Clinical Trials Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Apr 15, 2025; 17(4): 103311
Published online Apr 15, 2025. doi: 10.4251/wjgo.v17.i4.103311
Efficacy and safety of early pancreatic duct stenting for unresectable pancreatic cancer: A randomized controlled trial
Min-Hui Sun, Hong-Zhang Shen, Hang-Bin Jin, Jian-Feng Yang, Xiao-Feng Zhang
Min-Hui Sun, Department of Gastroenterology, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, Hangzhou 310000, Zhejiang Province, China
Min-Hui Sun, Department of Gastroenterology, The Fourth Clinical Medical College of Zhejiang Chinese Medicine University, Hangzhou 310000, Zhejiang Province, China
Hong-Zhang Shen, Hang-Bin Jin, Jian-Feng Yang, Xiao-Feng Zhang, Department of Gastroenterology, The Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou Digestive Disease Research Institute, Key Laboratory of Pancreatobiliary Disease of Zhejiang Integrated Chinese and Western Medicine, Hangzhou 310000, Zhejiang Province, China
Author contributions: Zhang XF and Yang JF contributed to study design, reviewing, and final approval; Sun MH contributed to data collection, analysis, manuscript writing, and reviewing; Shen HZ and Jin HB contributed to manuscript reviewing; All authors contributed to the article and approved the submitted version.
Supported by The Health Commission of Zhejiang Provence, China, No. WKJ-ZJ-2136.
Institutional review board statement: The study studies involving human participants were reviewed and approved by the Ethics Committee of the Hangzhou First People’s Hospital [(Approval No. KY-20201114-0178-01]) and conducted with Declaration of Helsinki. All authors had access to the study data, and reviewed and approved the final manuscript submitted for publication.
Clinical trial registration statement: This study was registered at [Chictr.org]. The registration identification number is [ChiCTR2400090684].
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Technical appendix and dataset available from the corresponding author at [email: zxf837@126.com]. Participants gave informed consent for data.
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: Xiao-Feng Zhang, Chief Physician, Professor, Department of Gastroenterology, The Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou Digestive Disease Research Institute, Key Laboratory of Pancreatobiliary Disease of Zhejiang Integrated Chinese and Western Medicine, No. 261 Huansha Road, Hangzhou 310000, Zhejiang Province, China. zxf837@126.com
Received: November 18, 2024
Revised: January 1, 2025
Accepted: February 10, 2025
Published online: April 15, 2025
Processing time: 130 Days and 2.9 Hours
Abstract
BACKGROUND

Palliative care for unresectable pancreatic cancer (PC) focuses mainly on the symptoms of the disease, including abdominal pain, obstructive jaundice, and malnutrition. Biliary stent placement using endoscopic retrograde cholangiopancreatography (ERCP) to relieve biliary obstruction has become an internationally recognized treatment. Although a few studies have evaluated the efficacy of endoscopic pancreatic duct stenting in advanced PC, no consensus exists on the use of endoscopic treatment to relieve pain and improve nutritional status.

AIM

To evaluate the efficacy and safety of early pancreatic duct stenting in patients with unresectable PC.

METHODS

Patients with unresectable PC were recruited. The participants were randomized into two groups: The double-stent group underwent ERCP with a fully-covered self-expandable metallic biliary stent (FCSEMS) and a pancreatic duct stent, while the single-stent group underwent ERCP with an FCSEMS only. Abdominal pain, nutritional status, and incidence of adverse events were compared between the two groups using the SPSS software.

RESULTS

Seventy-eight patients with unresectable PC were included in the analysis (40 and 38 in the double- and single-stent groups, respectively). The median pain scores of patients in the double-stent group were lower than those in the single-stent group at 1 (0 vs 2.5, P = 0.002), 2 (0 vs 3, P < 0.001), 3 (0 vs 4, P < 0.001), and 6 months (0 vs 4, P < 0.001) after ERCP. Total serum protein levels in patients in the double-stent group were higher than those in the single-stent group (66.6 ± 8.4 g/L vs 60.4 ± 4.0 g/L, P = 0.046) 6 months postoperatively. The body mass index (BMI) of patients in both groups decreased at six months. However, the BMI in the single-stent group was higher than that in the double-stent group (P < 0.001).

CONCLUSION

Early pancreatic duct stenting reduces abdominal pain and improves nutritional status in patients with unresectable PC without reducing the technical success rate or increasing the incidence of adverse events.

Keywords: Abdominal pain; Nutritional status; Pancreatic duct stenting; Unresectable pancreatic cancer; Endoscopic retrograde cholangiopancreatography

Core Tip: The early and effective improvement of abdominal pain and malnutrition in patients with unresectable pancreatic cancer (PC) is a key component of clinical treatment. Our findings suggest that early pancreatic duct stenting can reduce abdominal pain and improve the nutritional status of patients with unresectable PC.