Clinical trial NCT02001779: IRS(Irradiation Stent) vs. CS(Conventional Stent) Insertion in Inoperable Malignant Biliary Obstruction
Official title: Study of Stent Insertion Combined With or Without Brachytherapy in Patients With Inoperable Malignant Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Biliary Obstruction
Keywords: Malignant biliary obstruction
Obstruction/stricture
Stent
Brachytherapy
Bile duct
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patency
timeFrame: Participants will be followed till die or lost to follow-up,an expected average of a year.
Secondary outcomes:
measure: Over survival
timeFrame: Participants will be followed till die or lost to follow-up,an expected average of a year.
measure: Clinical success
timeFrame: Participants will be followed till die or lost to follow-up,an expected average of a year.
measure: Safety
timeFrame: Participants will be followed till die or lost to follow-up,an expected average of a year.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital,Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-jun Teng, Ph.D,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.