IRS(Irradiation Stent) vs. CS(Conventional Stent) Insertion in Inoperable Malignant Biliary Obstruction (IRCSMBO)

Study of Stent Insertion Combined With or Without Brachytherapy in Patients With Inoperable Malignant Biliary Obstruction

Stenting the malignant biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated the safety and technical feasibility of an irradiation biliary stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.

Study Overview

• Status: Completed
• Conditions: Malignant Biliary Obstruction
• Intervention / Treatment: Device: Biliary SEMS loaded with 125I seeds; Device: Conventional biliary SEMS

Detailed Description

Malignant biliary obstruction is a common condition caused by various carcinomas.The clinical process is usually silent and insidious,only 10-20% patients can be surgically removed once obstructive jaundice occurred.The long-term survival rate after resection remain dismal.Relief of obstructive jaundice plays major role on prognosis in patients without surgical indications.For unresectable patients,stenting the biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice.Although a number of new techniques for treatment of malignant biliary obstruction have been developed,there have been no significant differences in survival or quality of life comparing surgery bypass versus plastic stent insertion,metal stent insertion versus plastic stents insertion,or covered stent versus uncovered stents insertion in such patients.Our previous unicentric clinical trial has demonstrated the safety and technical feasibility of a biliary intraluminal irradiation stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion in the overall survival and stent patency between two groups.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital，Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical,histological or pathological diagnosis of malignant biliary obstruction
• Unresectability or refusal to be surgically treated
• The Eastern Cooperative Oncology Group(ECOG) scores from 0 to 3
• With symptoms such as jaundice related to biliary obstruction
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• Biliary obstruction of Bismuthe-Corlette,type I and II

Exclusion Criteria:

• Benign biliary obstruction
• The Eastern Cooperative Oncology Group(ECOG) score of 4
• Biliary tract stricture that could not be dilated enough to pass the delivery system
• Presence of metallic biliary stent or bile duct surgery
• Percutaneous transhepatic cholangiography(PTC) procedure was contraindicated
• Active hepatitis
• Biliary obstruction of Bismuthe-Corlette,type Ⅲ and Ⅳ
• Uncooperative or could not provide authorization and signature

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biliary SEMS loaded with 125I seeds; A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.	Device: Biliary SEMS loaded with 125I seeds; A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.
Active Comparator: Conventional biliary SEMS; A self-expandable metallic biliary stent is inserted in patients with inoperable malignant biliary obstruction.	Device: Conventional biliary SEMS; A self-expandable metallic stent is inserted in patients with inoperable malignant biliary obstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency	Time from stenting to the day when stricture/obstruction of the stent occured or restricture/reobstruction after recanalization the obstructed stent.	Participants will be followed till die or lost to follow-up,an expected average of a year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Over survival	Time from stenting to the day when the patients died or lost to the follow-up.	Participants will be followed till die or lost to follow-up,an expected average of a year.
Clinical success	The rate of relief of the symptoms and signs of the patients.	Participants will be followed till die or lost to follow-up,an expected average of a year.
Safety	Including technique success rate,side effect/complication,radioactive safety.	Participants will be followed till die or lost to follow-up,an expected average of a year.

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-jun Teng, Ph.D,MD, Zhongda Hospital Southeast University

Publications and helpful links

General Publications

• Zhu HD, Guo JH, Huang M, Ji JS, Xu H, Lu J, Li HL, Wang WH, Li YL, Ni CF, Shi HB, Xiao EH, Lv WF, Sun JH, Xu K, Han GH, Du LA, Ren WX, Li MQ, Mao AW, Xiang H, Zhang KX, Min J, Zhu GY, Su C, Chen L, Teng GJ. Irradiation stents vs. conventional metal stents for unresectable malignant biliary obstruction: A multicenter trial. J Hepatol. 2018 May;68(5):970-977. doi: 10.1016/j.jhep.2017.12.028. Epub 2018 Jan 10.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 12, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Stent; Brachytherapy; Malignant biliary obstruction; Obstruction/stricture; Bile duct
• Other Study ID Numbers: IR-C-STENT-MBO-83272121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No