Zhu DS, Zhang Z, Huang XR, Zhang JZ, Zhang ZW, Guo XY, Zheng H, Guo T, Yu YH. Textbook outcome and associated risk factors in laparoscopic transcystic common bile duct exploration. World J Gastroenterol 2025; 31(31): 109994 [DOI: 10.3748/wjg.v31.i31.109994]
Corresponding Author of This Article
Ya-Hong Yu, MD, Chief Physician, FRCS (Gen Surg), Professor, Department of Biliopancreatic Surgery, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan 430000, Hubei Province, China. yuyahong615@sina.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Retrospective Cohort Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Deng-Sheng Zhu, Zhen Zhang, Xiao-Rui Huang, Jing-Zhao Zhang, Zhi-Wei Zhang, Xin-Yi Guo, Huan Zheng, Tong Guo, Ya-Hong Yu, Department of Biliopancreatic Surgery, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430000, Hubei Province, China
Co-corresponding authors: Tong Guo and Ya-Hong Yu.
Author contributions: Zhu DS and Zhang Z contributed equally to this work as co-first authors; Zhu DS was responsible for study design, data curation, conceptualization, methodology, and drafting the initial manuscript; Zhang Z performed formal data analysis and co-drafted the manuscript; Huang XR and Zhang JZ completed case data collection, follow-up, and data organization; Zhang ZW and Guo XY provided manuscript revision suggestions; Zheng H participated in the literature search for the manuscript and the production of related figures and tables; Guo T and Yu YH, as co-corresponding authors, contributed equally to study supervision, funding acquisition, and critical review/editing of the manuscript. All authors approved the final version of the manuscript.
Institutional review board statement: The study was approved by the Ethics Committee of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, No. TJ-IRB202504074.
Informed consent statement: After review by the Ethics Committee of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, a waiver of informed consent was granted for this subject.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author. Participants gave informed consent for data sharing.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ya-Hong Yu, MD, Chief Physician, FRCS (Gen Surg), Professor, Department of Biliopancreatic Surgery, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan 430000, Hubei Province, China. yuyahong615@sina.com
Received: May 28, 2025 Revised: June 20, 2025 Accepted: July 25, 2025 Published online: August 21, 2025 Processing time: 82 Days and 21.3 Hours
Abstract
BACKGROUND
Textbook outcome (TO), an emerging composite metric for surgical quality assessment, has recently gained recognition for evaluating perioperative results. Laparoscopic transcystic common bile duct exploration (LTCBDE) has become a widely adopted minimally invasive technique for treating cholecystolithiasis with choledocholithiasis. Despite its growing clinical application, TO has not yet been formally defined for LTCBDE, nor have its failure-associated risk factors been systematically examined.
AIM
To define TO for LTCBDE, establish standardized criteria, and identify risk factors for TO failure via logistic regression.
METHODS
A retrospective cohort of 388 patients who underwent LTCBDE in combination with laparoscopic cholecystectomy at the Department of Biliopancreatic Surgery, Tongji Hospital, from January 2018 to October 2024, was analyzed. The study delineated TO criteria for LTCBDE, calculated the rate of TO achievement, and employed logistic regression to determine independent predictors of TO failure.
RESULTS
TO was defined as the absence of the following seven criteria: Conversion to open surgery, postoperative complications (Clavien-Dindo grade ≥ 2), biliary leakage (International Study Group of Pancreatic Surgery/International Study Group of Liver Surgery grade B/C), delayed removal of drainage tube (> 4 days), postoperative interventions, prolonged length of stay (> 7 days), and 30-day readmission or mortality. Among 388 patients, 276 (71.1%) achieved TO. The primary causes of TO failure included delayed removal of drainage tube (94 cases, 83.9%), prolonged length of stay (50 cases, 44.6%). Multivariate analysis revealed four independent risk factors for TO failure: Preoperative endoscopic retrograde cholangiopancreatography (P = 0.022), advanced age (P = 0.010), prolonged anesthesia time (P < 0.001), and elevated preoperative alkaline phosphatase levels (P = 0.048).
CONCLUSION
These findings suggest that applying the concept of TO to LTCBDE enhances surgical quality evaluation and supports early identification of high-risk patients, facilitating personalized clinical decisions and optimizing individual management.
Core Tip: This study defined textbook outcome (TO) criteria for laparoscopic transcystic common bile duct exploration as the absence of seven criteria: Conversion to open surgery, postoperative complications (Clavien-Dindo grade ≥ 2), biliary leakage (International Study Group of Pancreatic Surgery/International Study Group of Liver Surgery grade B/C), delayed removal of drainage tube (> 4 days), postoperative interventions, prolonged length of stay (> 7 days), and 30-day readmission or mortality. Factors independently associated with TO failure included preoperative endoscopic retrograde cholangiopancreatography, advanced age, prolonged anesthesia time, and elevated preoperative alkaline phosphatase levels. This investigation addresses the existing gap in TO evaluation within laparoscopic transcystic common bile duct exploration and contributes to risk stratification efforts, optimizing individual management.
Citation: Zhu DS, Zhang Z, Huang XR, Zhang JZ, Zhang ZW, Guo XY, Zheng H, Guo T, Yu YH. Textbook outcome and associated risk factors in laparoscopic transcystic common bile duct exploration. World J Gastroenterol 2025; 31(31): 109994
In patients diagnosed with symptomatic cholecystolithiasis, concurrent choledocholithiasis is observed in 10%-20% of cases, with prevalence increasing among the elderly population[1-3]. Advances in endoscopic and laparoscopic modalities have expanded therapeutic strategies, including laparoscopic cholecystectomy (LC) combined with preoperative, intraoperative, or postoperative endoscopic retrograde cholangiopancreatography (ERCP); laparoscopic common bile duct exploration (LCBDE) with either T-tube drainage or stent insertion; and laparoscopic transcystic common bile duct exploration (LTCBDE)[3-5]. Compared to LC with LCBDE, LTCBDE avoids complications linked to T-tube utilization, such as electrolyte disturbances, tube displacement, retrograde infections, and diminished postoperative quality of life[3,6]. Furthermore, by avoiding direct incision of the common bile duct, LTCBDE substantially lowers the risk of iatrogenic ductal injury and markedly reduces the incidence of biliary fistula formation[7]. In a cohort study involving 4223 patients, LTCBDE was associated with a significantly lower incidence of bile leakage compared to LCBDE [odds ratio (OR) = 0.46, 95% confidence interval (CI): 0.23-0.93], as well as reduced operative time [mean difference (MD) = 0.86, 95%CI: 0.77-0.97] and shorter postoperative hospitalization (MD = 0.78, 95%CI: 0.42-1.14)[8]. A separate trial comparing 150 patients per group reported that the LTCBDE + LC group achieved a shorter hospital stay (4.31 ± 0.69 days vs 4.73 ± 1.26 days; t = 2.28, P < 0.001) and significantly decreased total medical expenses (16173 ± 558.5 yuan vs 19852 ± 1481.3 yuan; t = 4.11, P < 0.001)[9]. Overall, LTCBDE has been demonstrated to reduce operative time, perioperative complication rates, length of hospitalization, and total costs relative to LCBDE[7], contributing to its increasing clinical adoption. Unlike LC combined with preoperative, intraoperative, or postoperative ERCP, LTCBDE enables one-stage management of both cholecystolithiasis and choledocholithiasis under a single anesthesia session. Despite comparable overall therapeutic efficacy between the two approaches[3]. LTCBDE avoids ERCP-associated adverse events such as acute pancreatitis, biliary tract infections, and gastrointestinal hemorrhage[10]. Further evidence indicates that LTCBDE is linked to reduced total hospitalization duration and overall expenditure compared with LC + ERCP[11]. Specifically, mean hospitalization length was 9.28 ± 3.01 days for LTCBDE, vs 13.04 ± 3.51 days for LC + ERCP (P < 0.001), while mean hospitalization cost for LTCBDE amounted to 29153.10 ± 9953.99 yuan, significantly lower than 49453.19 ± 7766.62 yuan in the LC + ERCP group (P < 0.001).
However, LTCBDE demands a high level of surgical expertise, including advanced competencies in both laparoscopy and choledochoscopy. Its implementation may be constrained by anatomical complexities, including a narrow or tortuous cystic duct and the presence of large bile duct stones[12]. Technological advancements, particularly the introduction of 3 mm ultra-thin choledochoscopes and the SpyGlass cholangioscopy system[13], have markedly improved procedural accessibility. Consequently, LTCBDE has emerged as the treatment of choice for patients with cholecystolithiasis accompanied by choledocholithiasis in top-tier hepatobiliary centers. Presently, quality evaluation of LTCBDE primarily depends on isolated metrics such as bile leakage rates and hospital length of stay (LOS), which inadequately reflect the overall perioperative performance. To achieve a more holistic appraisal of surgical quality, the adoption of a composite quality indicator is warranted[14].
The textbook outcome (TO) constitutes a composite quality metric that encapsulates optimal perioperative performance by integrating multiple clinical endpoints. Initially introduced in 2013 by Dutch colorectal surgeons[15], the TO framework was developed to define and measure the ideal outcome of colorectal surgical procedures. This optimal outcome is delineated by specific benchmarks: Hospital survival, complete tumor resection, absence of reintervention, avoidance of ostomy, no adverse events, and discharge within 14 days. In accordance with an “all-or-none” paradigm, TO is attained only when all predefined criteria are simultaneously met[16,17]. In 2018, TO was incorporated into hepatopancreatic surgery[18], subsequently undergoing substantial refinement for use in quality assessment across benign and malignant conditions of the liver, pancreas, and biliary system. Tailored TO criteria have since been proposed for hepatic resections, pancreatic procedures, and elective laparoscopic cholecystectomies[17,19,20]. For hepatobiliary-pancreatic interventions, TO commonly comprises the absence of surgical complications, no prolonged LOS, and no readmissions or mortality events[21,22]. Traditional evaluations of perioperative care, often limited to singular metrics such as morbidity, LOS, or mortality, inadequately reflect the multidimensional nature of clinical outcomes[18,23]. As a multidimensional aggregate endpoint, TO synthesizes key outcome measures and elements of perioperative care, yielding a more integrated and accurate depiction of the perioperative course. Its application in clinical practice enhances the precision of surgical quality assessments and supports iterative improvement of care standards[17,18]. To date, no studies have explicitly defined or documented TO in the context of LTCBDE. This study therefore aims to establish standardized TO criteria specific to LTCBDE and to conduct logistic regression analysis to identify predictors of TO failure, thereby generating an evidence-based framework for improving surgical quality and informing clinical decision-making.
MATERIALS AND METHODS
Population cohort
A total of 388 patients who underwent LTCBDE combined with LC at the Department of Biliopancreatic and Pancreatic Surgery, Tongji Hospital, from January 2018 to October 2024 were retrospectively evaluated. Eligibility criteria included: (1) Age ≥ 18 years; (2) Preoperative diagnosis based on magnetic resonance cholangiopancreatography (MRCP), computed tomography, endoscopic ultrasound, or biliary ultrasonography confirming at least one of the following: Cholecystolithiasis with choledocholithiasis; cholecystolithiasis with a common bile duct diameter ≥ 1 cm; biliary pancreatitis; biochemical evidence of biliary obstruction [total bilirubin (TB) ≥ 34.2 μmol/L, alkaline phosphatase (ALP) > 1.5 × upper limit of normal, alanine aminotransferase/aspartate aminotransferase > 1.5 × upper limit of normal][24]; and (3) Completion of LTCBDE combined with LC. Exclusion criteria comprised: (1) Biliary tract malignancies; (2) Intrahepatic bile duct calculi; (3) Cystic duct anomalies, including diameter < 3 mm; tortuous, sharply angled, or left-sided insertion into the common hepatic duct; Mirizzi syndrome; (4) Emergency intervention for acute suppurative cholangitis; (5) Previous upper abdominal open surgery; and (6) Incomplete clinical data. All procedures were performed by a single surgeon, Yu YH. The study protocol received approval from the Ethics Committee of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology.
Surgical procedure
Patients were placed in the supine position under general anesthesia. A 1.5-2 cm infraumbilical incision was created to establish pneumoperitoneum at an intra-abdominal pressure of approximately 12 mmHg. A trocar, cannula, and laparoscope were inserted in sequence. Additional ports were introduced via puncture sites at the xiphoid process, 2 cm inferior to the right midclavicular line at the costal margin, and 2 cm below the right anterior axillary line at the costal margin (Figure 1). Comprehensive inspection of the gallbladder, common bile duct, hepatic, pancreatic, and pelvic regions was conducted to assess for neoplastic involvement.
Figure 1 Trocar position.
A 1.5-2 cm infraumbilical incision was created to establish pneumoperitoneum at an intra-abdominal pressure of approximately 12 mmHg. A trocar, cannula, and laparoscope were inserted in sequence. Additional ports were introduced via puncture sites at the xiphoid process, 2 cm inferior to the right midclavicular line at the costal margin, and 2 cm below the right anterior axillary line at the costal margin.
Adhesiolysis was performed to expose the cystic triangle. The cystic artery and duct were dissected and ligated near the gallbladder using absorbable clips. A transverse incision was created 1-2 cm distal to the common bile duct, followed by a longitudinal T-shaped extension along the cystic duct to prevent iatrogenic common bile duct injury. Based on the cystic duct diameter, a 3 mm or 5 mm choledochoscope was introduced through the incision. Sequential ductal dilation was conducted using 6F to 16F dilators (a minimum of 10F for a 3 mm choledochoscope; 16F for a 5 mm choledochoscope). The choledochoscope was then advanced to inspect the common bile duct, and calculi were extracted with a standard retrieval basket. In cases where the stone-to-cystic duct diameter ratio was ≥ 1, the incision was extended to the cystic duct-common bile duct junction, and a minor incision into the common bile duct was performed. Fragmentation was achieved using electrohydraulic lithotripsy or biopsy forceps. The duct was irrigated with normal saline until clearance of residual stones was confirmed. Following choledochoscope withdrawal, the cystic duct-common bile duct junction was closed with absorbable sutures, and the proximal cystic duct was re-clipped using absorbable clips. The gallbladder was excised entirely and retrieved (Figure 2). A peritoneal drain was positioned in the foramen of Winslow, and the abdominal wall incision was closed. On postoperative day two, routine abdominal ultrasonography was performed to assess for ascites. In the absence of significant fluid accumulation or biliary leakage, the drain was removed between postoperative days 3 and 4.
Figure 2 Surgical procedure.
A: Clip the cystic artery and the gallbladder-side of the cystic duct, make a transverse incision on the cystic duct 1-2 cm from the common bile duct, and extend a longitudinal incision from the transverse incision along the cystic duct to its junction with the common bile duct; B: Sequentially insert 6F, 8F, 10F, 12F, 14F, and 16F dilators through the incision to dilate the bile duct; C: Insert a choledochoscope through the cystic duct to explore the common bile duct and remove stones; D: Perform interrupted suture at the junction of the cystic duct and common bile duct with absorbable sutures; E: Clip the cystic duct with absorbable clips; F: Complete cholecystectomy.
Data collection
Patient characteristics included sex, age, body mass index, American Society of Anesthesiologists classification, and comorbidities including hypertension, diabetes, and coronary artery disease. Laboratory assessments at admission involved leukocyte, neutrophil, and platelet counts; alanine aminotransferase, aspartate aminotransferase, TB, direct bilirubin, ALP, γ-glutamyl transferase; serum and urine amylase; and fasting blood glucose levels. Preoperative imaging parameters included maximum common bile duct diameter, number and size of choledocholiths, gallbladder wall thickness, cystic duct diameter, and presence of intrahepatic bile duct dilatation. Diagnoses prior to surgery comprised cholecystolithiasis, cholecystolithiasis with choledocholithiasis, and biliary pancreatitis. Preoperative procedures included ERCP and biliary drainage via percutaneous transhepatic gallbladder drainage (PTGD) or percutaneous transhepatic cholangial drainage. Intraoperative variables included choledochoscope size (3 mm or 5 mm), conversion to open surgery, and anesthesia duration. Postoperative parameters covered complication severity (Clavien-Dindo classification), biliary leakage grade [International Study Group of Pancreatic Surgery (ISGPS)/International Study Group of Liver Surgery (ISGLS)], duration until peritoneal drain removal, LOS, requirement for additional interventions, and 30-day readmission or mortality.
TO definition
The literature was systematically analyzed, and TO was defined by the simultaneous absence of the following seven outcomes: Conversion to open surgery, postoperative complications (Clavien-Dindo grade ≥ 2), biliary leakage (ISGPS/ISGLS grade B/C), delayed drainage tube removal (> 75th percentile, > 4 days), postoperative interventions (ERCP, ultrasound-guided drainage, or reoperation), prolonged LOS (> 75th percentile, > 7 days), and 30-day readmission or mortality. Achievement of TO necessitated fulfillment of all listed criteria. Thresholds for prolonged LOS and delayed drain removal were determined as > 7 days and > 4 days, respectively, based on statistical distribution. Currently, a standardized definition for prolonged hospitalization following LTCBDE remains unavailable. However, prior research on hepatobiliary-pancreatic surgery has frequently adopted the absence of prolonged LOS, defined as not exceeding the 75th percentile, as a surrogate marker of TO[21]. Consistent with international protocols, studies in laparoscopic liver and pancreatic surgery have incorporated similar LOS benchmarks into TO criteria, generally identifying durations beyond the 75th percentile as prolonged[25,26]. In this study, LOS > 7 days was categorized accordingly. Nonetheless, clinical application of this benchmark requires contextual adjustment, accounting for institutional variations in healthcare resources and perioperative care standards. As a high-volume hepatobiliary-pancreatic center in mainland China, the parameters used herein may necessitate extended postoperative observation when translated to primary care settings, potentially resulting in longer hospital stays. Moreover, no existing literature has yet integrated delayed postoperative drain removal into the definition of TO. In hepatobiliary-pancreatic surgery, abdominal drainage tubes are routinely employed to monitor postoperative complications and maintain adequate fluid evacuation. However, substantial heterogeneity persists regarding the timing of drainage tube placement and removal in LTCBDE, influenced by regional practices, institutional protocols, and individual surgeon preferences. At this center, clinical data indicate that drainage tubes are typically removed within 3 to 4 days postoperatively, with the 75th percentile for removal time exceeding 4 days, findings consistent with observed local practice patterns. Integrating the absence of delayed drainage tube removal into the TO criteria aligns with institutional standards and strengthens the evaluation of surgical performance and benchmark outcome metrics. Nonetheless, adaptation of TO criteria should consider local healthcare infrastructure, nursing protocols, and economic contexts to ensure clinical applicability and relevance.
Statistical analysis
The TO achievement rate was quantified, and comparisons of preoperative and intraoperative parameters between the TO and non-TO cohorts were conducted. Continuous variables with normal distributions were reported as mean ± SD and evaluated using independent samples t-tests. For non-normally distributed variables, data were summarized as medians with interquartile ranges and analyzed using Mann-Whitney U or Kruskal-Wallis tests, depending on group comparisons. Categorical data were expressed as counts and percentages, and assessed via Pearson’s χ² test or Fisher’s exact test, based on distributional assumptions. To determine variables independently associated with TO, both univariate and multivariate logistic regression analyses were implemented, with OR and corresponding 95%CI calculated. Variables exhibiting P < 0.1 in univariate analysis were incorporated into the multivariate model. All statistical procedures were executed using SPSS version 27.0 (IBM Corp., Armonk, NY, United States) and R version 4.4.3 (R Foundation for Statistical Computing, Vienna, Austria), with R analyses performed through RStudio version 2024.12.1 (Posit Software, Boston, MA, United States). Statistical significance was defined as a two-tailed P < 0.05.
RESULTS
A total of 388 patients undergoing LTCBDE + LC were analyzed, comprising 180 males (46.4%) and 208 females (53.6%), with a median age of 53.5 years (range: 18-84; Table 1). No 30-day mortality was observed. Postoperative interventions were necessary in 10 cases (2.6%): 2 patients (0.5%) presented with residual common bile duct stones identified postoperatively and managed by ERCP; 8 required ultrasound-guided peritoneal drainage for fluid collections. No reoperations were recorded. Four patients (1.0%) were readmitted within 30 days. One was a 62-year-old male initially diagnosed with acute biliary pancreatitis who underwent LTCBDE + LC on hospital day 5. After an uneventful postoperative course, including drain removal on day 4 and discharge on day 6, he was readmitted on day 27 due to persistent fever (39 °C) lasting two days. Imaging confirmed acute pancreatitis with peripancreatic effusion, and conservative management led to discharge after 11 days. Another case involved a 58-year-old female with cholecystolithiasis and choledocholithiasis who had an uncomplicated recovery (drain removed on day 4, discharged on day 5). She was readmitted on day 20 with abdominal pain and jaundice; MRCP revealed a biliary stricture, which was successfully treated with ERCP and endoscopic stent placement. The stent was removed after 3 months, with normalization of liver function and no evidence of restenosis at follow-up. The remaining two patients, males aged 55 and 68 with similar biliary pathology, were discharged on postoperative day 6 (drains removed on day 4). They were readmitted on days 21 and 25 with recurrent upper abdominal pain. Both were diagnosed with postcholecystectomy syndrome attributed to Oddi’s sphincter spasm, and responded to oral pinaverium bromide following spasmolytic treatment.
Table 1 Univariate comparison of preoperative variables between textbook outcome and non-textbook outcome groups.
A total of 276 patients (71.1%) met the TO criteria, with perioperative outcomes showing no statistically significant differences between the TO and non-TO groups (Table 1). Among the 112 patients (28.9%) who failed to achieve TO, the primary contributing factor was delayed removal of the drainage tube (> 4 days), observed in 94 cases (83.9%), followed by extended LOS in 50 cases (44.6%; Table 2). Univariate analysis revealed that patients in the non-TO group had a significantly higher median age [59 (28, 84) vs 52 (18, 83), P < 0.01], as well as elevated preoperative TB (25.6 μmol/L vs 18.5 μmol/L, P = 0.018), direct bilirubin (13.6 μmol/L vs 9.5 μmol/L, P = 0.005), and blood glucose levels (5.59 mmol/L vs 5.04 mmol/L, P = 0.004). Additionally, greater common bile duct stone diameter (0.5 cm vs 0.3 cm, P = 0.004) and increased incidence of preoperative ERCP (7.1% vs 1.4%, P = 0.007) were noted in the non-TO cohort.
Table 2 Analysis of perioperative factors associated with textbook outcome failure, n (%).
Univariate and multivariate logistic regression analyses were conducted to identify variables independently associated with TO achievement. Variables with P < 0.1 in univariate analysis were entered into the multivariate model. Independent predictors of TO failure included preoperative ERCP (OR = 5.408; 95%CI: 1.28-22.92; P = 0.022), advanced age (OR = 1.03; 95%CI: 1.01-1.05; P = 0.010), prolonged anesthesia duration (OR = 1.02; 95%CI: 1.01-1.02; P < 0.001), and elevated preoperative ALP levels (OR = 1.002; 95%CI: 1.000-1.005; P = 0.048; Table 3).
Table 3 Univariate and multivariate analysis of risk factors for achieving textbook outcome after laparoscopic transcystic common bile duct exploration.
In this study, receiver operating characteristic curves were constructed to assess the predictive performance of age, preoperative ALP level, preoperative ERCP, and anesthesia duration in relation to TO failure. As depicted in Figure 3, all curves remained above the reference line, indicating varying degrees of discriminatory capacity. Among the variables, anesthesia duration yielded the highest area under the curve (AUC) at 0.679 (95%CI: 0.617-0.741, P = 0.000), reflecting moderate predictive accuracy. Age followed with an AUC of 0.628 (95%CI: 0.566-0.690, P < 0.001), suggesting relevant prognostic potential. Preoperative ALP and ERCP demonstrated relatively lower AUCs of 0.554 and 0.528, respectively, yet maintained measurable associations with outcome prediction.
Figure 3 Nomogram for predicting the probability of achieving textbook outcome after laparoscopic transcystic common bile duct exploration.
ALP: Alkaline phosphatase; ERCP: Endoscopic retrograde cholangiopancreatography.
Collectively, the receiver operating characteristic curves and AUC values provide intuitive and quantitative evidence for evaluating the predictive ability of these variables. Based on the multivariate regression model, a nomogram (Figure 4) was established to integrate these independent predictors into a quantitative risk stratification tool for TO failure. Each predictor contributes to a cumulative score, which maps onto a probability axis; a total score exceeding 140 corresponds to an estimated risk greater than 80%. This visual algorithm enables efficient, individualized risk estimation, supporting clinical judgment and informing treatment strategy.
Figure 4 Receiver operating characteristic curve for risk factors associated with textbook outcome failure after laparoscopic transcystic common bile duct exploration.
ROC: Receiver operating characteristic; ALP: Alkaline phosphatase; ERCP: Endoscopic retrograde cholangiopancreatography.
DISCUSSION
With ongoing advancements in endoscopic and laparoscopic techniques, LC + LTCBDE has emerged as the preferred strategy for managing concomitant gallbladder and common bile duct stones in many tertiary medical centers. Compared with LC + LCBDE, the LTCBDE approach avoids common bile duct incision, thereby reducing the likelihood of bile duct trauma and biliary leakage, while also avoiding T-tube–related complications such as electrolyte disturbances, retrograde infections, and tube dislodgement[3,6,7]. LTCBDE is associated with reduced operative time, lower perioperative morbidity, shorter hospitalizations, and decreased treatment costs relative to LCBDE[7-9]. When evaluated against LC + ERCP, LTCBDE achieves comparable therapeutic outcomes, yet confers additional benefits, including shorter hospital stay, reduced financial burden, elimination of dependence on an endoscopic team, and avoidance of ERCP-associated complications such as acute pancreatitis, infection, gastrointestinal hemorrhage, and perforation[3,10,11]. Collectively, LTCBDE minimizes hospitalization duration, alleviates financial strain on patients, and optimizes the utilization of healthcare resources[11,27]. These benefits have led to its increasing adoption among surgeons. Nonetheless, an internationally standardized protocol for LTCBDE indications and operative procedures remains undefined. Suitability for LTCBDE must be determined through a comprehensive preoperative evaluation, including color Doppler ultrasound, MRCP, abdominal computed tomography, or endoscopic ultrasound, combined with patient history, general condition, and intraoperative assessment. Anatomical prerequisites include a cystic duct of adequate diameter and configuration, and common bile duct stones that are not excessively large[12,28]. Technical competence in both choledochoscopy and laparoscopy is fundamental for performing LTCBDE, which demands substantial procedural experience; previous reports indicate that proficiency typically requires approximately 250 cases[28]. At present, surgical quality assessment for LTCBDE predominantly relies on isolated perioperative indicators, which lack the breadth to accurately characterize overall performance. In contrast, TO, a multidimensional composite metric, includes multiple facets of perioperative management and has been validated across various surgical disciplines, including gallbladder, hepatic, pancreatic, and esophageal procedures[17,20,29,30]. However, no prior studies have defined or reported TO in the setting of LTCBDE. The present study sought to establish TO criteria specific to LTCBDE and determine predictors of TO failure.
Based on existing literature review, TO for LTCBDE was defined by the absence of seven criteria: Conversion to open surgery, postoperative complications (Clavien-Dindo grade ≥ 2), biliary leakage (ISGPS/ISGLS grade B/C), delayed drainage tube removal (> 4 days), postoperative interventions (ERCP, ultrasound-guided drainage, or reoperation), prolonged LOS (> 7 days), and 30-day readmission or mortality. Fulfillment of all seven criteria constituted achievement of TO. Definitions for prolonged hospital stay (> 7 days) and delayed drain removal (> 4 days) were determined based on statistical thresholds derived from this cohort. In the current analysis, the TO achievement rate for LTCBDE was 71.1%. While no comparative data for LTCBDE TO rates exist, this value falls below the rate reported for elective LC (85.5%)[17], a difference likely influenced by the increased complexity associated with choledocholithiasis. Patients undergoing LTCBDE often present with more intricate pathophysiology and operative challenges than those treated for uncomplicated gallbladder disease. Common bile duct stones frequently result in complications such as cholangitis, obstructive jaundice, and gallstone pancreatitis, with incidence rates ranging from 5.9% to 8.9%, substantially exceeding the 1%-4% observed in cases of uncomplicated cholelithiasis[31,32]. The prevalence of choledocholithiasis also increases markedly with age, affecting 8%-15% of individuals under 60 and rising to 15%-60% in those over 60[33]. In this study, advancing age was independently associated with an elevated likelihood of postoperative TO failure (OR = 1.03; P = 0.010), likely attributable to increased comorbidity burden and diminished physiological reserve in elderly patients[34,35]. This age-related trend may partly account for the lower TO rate observed following LTCBDE compared to elective LC. Moreover, LTCBDE combined with LC presents greater technical complexity than LC alone, requiring more intricate navigation of biliary anatomy, extended operative time, and a heightened risk of intraoperative and postoperative complications, all of which contribute to prolonged hospitalization. These procedural and patient-related challenges help explain the modestly reduced TO achievement in LTCBDE. Among perioperative contributors to TO failure, delayed removal of the drainage tube (> 4 days) was most common, occurring in 94 cases (83.9%), followed by prolonged LOS (> 7 days) in 50 cases (44.6%). Previous TO criteria for hepatobiliary and pancreatic surgeries have generally excluded drainage duration as an evaluative component. However, this study incorporated it based on institutional data indicating a strong association between prolonged drainage and adverse postoperative trajectories in patients undergoing LC with LTCBDE. Notably, extended drainage duration alone accounted for 48.2% of TO failures, reinforcing its relevance as a primary determinant in outcome assessment. Multivariate logistic regression identified preoperative ERCP, advanced age, elevated preoperative ALP levels, and extended anesthesia duration as independent predictors of TO failure.
Preoperative ERCP was associated with a significantly increased risk (OR = 5.40, P = 0.022), potentially due to several interrelated mechanisms. ERCP carries an overall complication rate of approximately 5%-11%[4], with pancreatitis being the most frequent (3.5%-9.7%), followed by cholangitis, hemorrhage, and perforation[36,37]; such adverse events can directly impair perioperative outcomes. Additionally, preoperative ERCP may enhance biliary tract inflammation, thereby increasing intraoperative complexity and anesthesia duration during LTCBDE, especially in cases involving residual stone management. Comparative analysis in this study revealed significantly prolonged anesthesia times in patients with prior ERCP compared to those without (P < 0.01). Postoperatively, delayed resolution of inflammation attributable to ERCP-induced biliary irritation was reflected in longer hospital stays among ERCP patients (P = 0.007). Collectively, these factors suggest that preoperative ERCP contributes to TO failure not only through procedural complications but also by extending operative time and impeding recovery.
Advancing age is associated with an elevated likelihood of postoperative TO failure (OR = 1.03; P = 0.010), potentially reflecting a greater burden of comorbidities such as cardiovascular and cerebrovascular diseases, pulmonary dysfunction, and age-related organ decline, particularly in individuals aged ≥ 70 years. These conditions diminish physiological resilience to anesthesia and surgical stress, leading to prolonged recovery relative to younger cohorts[34,35]. Cardiovascular disease remains the primary cause of postoperative mortality following biliary surgery in the elderly population[38]. Furthermore, data from Table 1 revealed a higher incidence of coronary heart disease in the non-TO group (12.5% vs 4.3%), with significantly more elderly patients affected (P < 0.001).
ALP, a membrane-bound enzyme predominantly derived from hepatic and osseous sources, with limited contributions from the intestine, kidneys, and placenta[39], localizes primarily to the canalicular and apical membranes of biliary epithelial cells. Under physiological conditions, its serum concentration remains low. In the context of biliary obstruction or cholestasis, unlike bilirubin, which accumulates due to impaired excretion, increased biliary pressure and bile acid-induced epithelial disruption stimulate hepatic ALP synthesis and enhance membrane shedding, collectively driving a sharp rise in circulating ALP levels[40,41]. Notably, even subclinical or segmental cholestasis can elevate serum ALP in the absence of bilirubin elevation, rendering ALP a more sensitive indicator of cholestatic processes[42]. The current analysis identified elevated preoperative ALP as an independent predictor of TO failure, plausibly attributable to bile duct obstruction secondary to choledocholithiasis, which promotes bile stasis and increased intraductal pressure. Due to its higher sensitivity, ALP more reliably reflects both the presence and intensity of biliary obstruction. When obstruction is compounded by cholangitis, bile becomes vulnerable to colonization by Gram-negative bacilli[43]. The lipid A moiety of lipopolysaccharide in these organisms serves as the primary toxic determinant, triggering hepatic ALP synthesis. This enzyme dephosphorylates lipid A, thereby attenuating its endotoxin activity and exerting a hepatoprotective effect during inflammation[44,45]. However, elevated ALP also implicates the presence of concurrent biliary infection. Advanced obstruction impairs toxin clearance via the bile ducts and weakens Kupffer cell phagocytic function[44], resulting in a progressive ALP surge in response to endotoxins. This mechanistic sequence may explain the observed association between high preoperative ALP levels and TO failure.
Prolonged operation duration has been consistently associated with increased postoperative complication rates and prolonged hospitalization in general surgery populations[46,47]. In the present study, prolonged anesthesia time emerged as an independent predictor of TO failure following LTCBDE, with a statistically significant association (P < 0.001). The OR of 1.016 (95%CI: 1.010-1.023) highlights the cumulative impact of incremental intraoperative variations on TO attainment. Prolonged anesthesia exposure often reflects greater intraoperative anatomical complexity, elevated procedural difficulty, and possibly suboptimal preoperative patient status, factors known to elevate the likelihood of adverse postoperative events and delayed recovery trajectories.
In addition to the above risk factors, this study found no significant association between preoperative biliary drainage (percutaneous transhepatic cholangial drainage or PTGD) and TO outcomes. However, prior investigations in elective LC settings have identified preoperative cholecystostomy and ERCP as risk factors for TO failure[17]. For patients with acute cholecystitis and concomitant choledocholithiasis who are deemed high risk for emergency intervention, preoperative biliary decompression remains beneficial in reducing biliary pressure, mitigating inflammatory symptoms, and alleviating gallbladder wall edema. Among drainage modalities, ultrasound-guided PTGD is regarded as the preferred option for high-risk individuals with gallstone-related acute cholecystitis[48], given its ability to reduce operative difficulty, lower perioperative complication rates, and minimize conversion to open surgery[49]. Given the identified association between prolonged anesthesia duration and TO failure after LTCBDE, the potential role of preoperative biliary drainage in attenuating biliary inflammation, simplifying intraoperative management, and shortening operative time warrants further consideration. This approach may offer a strategy to improve TO achievement in selected high-risk populations.
Finally, this study discusses and prospects the gaps present in the current body of research on TO. It is acknowledged that preoperative liver reserve assessment remains essential for optimizing surgical risk stratification particularly in the context of patients with underlying hepatic dysfunction. Patients with liver cirrhosis complicated by cholelithiasis and cholecystitis exhibit significantly higher complication and mortality rates than non-cirrhotic counterparts, with cholecystectomy-associated mortality notably increased in this population[50]. This elevated risk primarily stems from coagulopathy and reduced hepatic reserve, which collectively heighten susceptibility to perioperative hemorrhage, postoperative infection, hepatic decompensation, prolonged hospitalization, and increased 30- and 90-day readmission rates[51]. Evaluation of hepatic function in cirrhotic patients commonly relies on the Child-Pugh classification and the model for end-stage liver disease score[52], while hepatic functional reserve is more precisely assessed using the indocyanine green clearance test. Among the parameters derived from this assay, the indocyanine green retention rate at 15 minutes is considered the most informative indicator for quantifying hepatic reserve capacity[53]. Previous significant international studies on TO in hepatobiliary and pancreatic surgery have identified a gap in the assessment of liver function reserve and coagulation function within TO studies focusing on elective LC and various pancreatic surgeries[17,19,26]. Notably, only TO studies pertaining to liver resection incorporated indicators such as cirrhosis status[20]. In our center’s prior clinical practice, preoperative indicators, including liver function reserve in patients undergoing LTCBDE, were not routinely monitored. Consequently, these indicators were not discussed in this study. Moving forward, integration of refined hepatic function metrics into preoperative risk stratification models is recommended, with validation across patient cohorts presenting with diverse degrees of hepatic dysfunction.
Limitation
This study presents several limitations. First, it is a single-center retrospective analysis comprising 388 patients treated at Tongji Hospital, introducing potential selection bias. Consequently, generalizability remains limited, and the applicability of conclusions across diverse geographic and institutional settings may be constrained. Broader validation of the identified TO criteria and associated risk factors requires prospective, multicenter investigations including varied surgical capacities and regional populations. Second, the definition of TO following LTCBDE may be subject to interpretative variability. In particular, the inclusion of postoperative drainage tube retention exceeding 4 days as a component of TO warrants further justification through standardized, multicenter evaluation. Discrepancies in the operationalization of TO criteria may lead to inconsistencies relative to internationally accepted benchmarks. Despite this, such criteria are essential for procedural standardization and for optimizing both clinical management and perioperative nursing care. Third, this study did not include an assessment of preoperative liver function reserve indices, such as the Child-Pugh score and indocyanine green retention rate at 15 minutes, which could influence risk stratification in patients with cirrhosis. Future research should incorporate these markers to enhance the optimization of therapeutic options criteria for various hepatic conditions. Fourth, long-term outcomes were not evaluated.
CONCLUSION
This study proposed TO as a novel evaluative endpoint for LTCBDE, formulated standardized criteria, and identified independent predictors of TO failure, including preoperative ERCP, advanced age, elevated preoperative ALP levels, and extended anesthesia duration. Based on the multivariate regression model, a nomogram was constructed to offer clinicians a streamlined preoperative risk stratification tool, enabling early identification of high-risk individuals and supporting the development of individualized perioperative management plans.
ACKNOWLEDGEMENTS
We acknowledge all patients who contributed to this study.
Footnotes
Provenance and peer review: Unsolicited article; Externally peer reviewed.
Peer-review model: Single blind
Specialty type: Gastroenterology and hepatology
Country of origin: China
Peer-review report’s classification
Scientific Quality: Grade C
Novelty: Grade D
Creativity or Innovation: Grade D
Scientific Significance: Grade C
P-Reviewer: Jiang J S-Editor: Wu S L-Editor: A P-Editor: Zhao S
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