Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Feb 6, 2021; 9(4): 801-811
Published online Feb 6, 2021. doi: 10.12998/wjcc.v9.i4.801
Biliary stent combined with iodine-125 seed strand implantation in malignant obstructive jaundice
Hui-Wen Wang, Xiao-Jing Li, Shi-Jie Li, Jun-Rong Lu, Dong-Feng He
Hui-Wen Wang, Xiao-Jing Li, Shi-Jie Li, Jun-Rong Lu, Dong-Feng He, Department of Interventional, Harbin Medical University Cancer Hospital, Harbin 150081, Heilongjiang Province, China
Author contributions: Wang HW and Li XJ drafted the manuscript and analyzed all the data; He DF performed the surgeries and acquired data; Li SJ and Lu JR assisted in all surgeries and data collection; He DF designed and supervised the study, analyzed all the data, and revised the manuscript.
Institutional review board statement: The study was reviewed and approved by the Medical Ethics Review Committee of Harbin Medical University Cancer Hospital.
Clinical trial registration statement: This registration policy applies to prospective, randomized, controlled trials only.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare no competing interests.
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: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Dong-Feng He, PhD, Research Scientist, Surgical Oncologist, Department of Interventional, Harbin Medical University Cancer Hospital, No. 150 Haping Street, Nangang District, Harbin 150081, Heilongjiang Province, China. 13644578588@139.com
Received: November 3, 2020
Peer-review started: November 3, 2020
First decision: November 20, 2020
Revised: November 23, 2020
Accepted: December 10, 2020
Article in press: December 10, 2020
Published online: February 6, 2021
Abstract
BACKGROUND

Malignant obstructive jaundice is mainly caused by cholangiocarcinoma. Only a few patients are indicated for surgical resection, and the 3-year survival rate is < 50%. For patients who are not eligible for surgery, biliary stent placement can relieve biliary obstruction and improve liver function and quality of life. However, restenosis after biliary stents has a poor prognosis and is a clinical challenge. Biliary stent combined with iodine-125 (125I) seed implantation can prolong stent patency and improve survival.

AIM

To evaluate the safety and efficacy of biliary stent combined with 125I seed strand implantation in malignant obstructive jaundice.

METHODS

We enrolled 67 patients between January 2016 and June 2018 with malignant obstructive jaundice and randomized them into a biliary stent combined with 125I seed strand treatment (combined) group (n = 32) and biliary stent (control) group (n = 35). All patients underwent enhanced computed tomography and magnetic resonance imaging and were tested for biochemical and cancer markers. Twelve patients underwent pathological examination before surgery. All patients were followed up by telephone or clinical visit. Postoperative liver function improvement, postoperative complications, stent patency time, and survival time were compared between the two groups. Prognostic risk factors were evaluated.

RESULTS

Technical success was achieved in all patients in both groups. Postoperative liver function improved significantly in all patients (total bilirubin, direct bilirubin, alanine aminotransferase, and aspartate aminotransferase decreased significantly in all patients, the P values were less than 0.05). There was no significant difference in preoperative or postoperative indexes between the two groups for changes in total bilirubin (P = 0.147), direct bilirubin (P = 0.448), alanine aminotransferase (P = 0.120), and aspartate aminotransferase (P = 0.387) between the two groups. The median stent patency time of the combined group was 9.0 ± 1.4 mo [95% confidence interval (CI): 6.3-11.8 mo], which was significantly longer than the that of the control group (6.0 ± 0.3 mo, 95%CI: 5.5-6.5 mo, P = 0.000). The median survival time of the combined group was 11.0 ± 1.4 mo (95%CI: 8.2-13.7 mo), which was significantly longer than that of the control group (7.0 ± 0.3 mo, 95%CI: 6.4-7.6 mo, P = 0.000). Location of obstruction and number of stents were independent risk factors affecting prognosis.

CONCLUSION

Biliary stent combined with 125I seed strand implantation is safe and effective in malignant obstructive jaundice and improves stent patency time and median survival time.

Keywords: Biliary stent, 125I, Obstructive jaundice, Malignant tumor, Clinical research, Surgery

Core Tip: For patients who are unable to undergo surgery, biliary stent placement can relieve biliary obstruction and prolong survival. However, previous studies relieved stenosis caused by an existing tumor lesion by placing an iodine-125 seed in the middle of the stent while ignoring both ends. Both ends of the stent can be reobstructed. We observed that extending the iodine-125 seed strand along the length of the stent produced a safe and effective result in malignant obstructive jaundice.