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

NCT02001779 | Completed DMC

• 1 other identifier: IR-C-STENT-MBO-83272121
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Biliary Obstruction

Keywords

Malignant biliary obstruction; Obstruction/stricture; Stent; Brachytherapy; Bile duct

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Over survival

  Participants will be followed till die or lost to follow-up,an expected average of a year.

• Clinical success

  Participants will be followed till die or lost to follow-up,an expected average of a year.

• Safety

  Participants will be followed till die or lost to follow-up,an expected average of a year.

Study Arms (2)

Biliary SEMS loaded with 125I seeds

EXPERIMENTAL

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

Conventional biliary SEMS

ACTIVE COMPARATOR

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

Device: Conventional biliary SEMS

Interventions

Biliary SEMS loaded with 125I seeds DEVICE

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

Biliary SEMS loaded with 125I seeds

Conventional biliary SEMS DEVICE

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

Conventional biliary SEMS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• 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.

  PMID: 29331343 DERIVED

MeSH Terms

Conditions

Bites and Stings; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gao-jun Teng, Ph.D,MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology & Chair,Department of Radiology

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 5, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)