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

NCT ID: NCT02001779

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-09-30

Brief Summary

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.

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.

Conditions

Malignant Biliary Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biliary SEMS loaded with 125I seeds

Intervention Type: DEVICE

A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.

Conventional biliary SEMS

A self-expandable metallic biliary stent is inserted in patients with inoperable malignant biliary obstruction.

Group Type: ACTIVE_COMPARATOR

Conventional biliary SEMS

Intervention Type: DEVICE

A self-expandable metallic stent is inserted in patients with inoperable malignant biliary obstruction.

Interventions

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.

Intervention Type: DEVICE

Conventional biliary SEMS

A self-expandable metallic stent is inserted in patients with inoperable malignant biliary obstruction.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gao-jun Teng

Professor of Radiology & Chair,Department of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gao-jun Teng, Ph.D,MD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 29331343 (View on PubMed)

Other Identifiers

IR-C-STENT-MBO-83272121

Identifier Type: -

Identifier Source: org_study_id