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

Southeast University

Status

Completed

Conditions

Malignant Biliary Obstruction

Treatments

Device: Biliary SEMS loaded with 125I seeds

Device: Conventional biliary SEMS

Study type

Interventional

Funder types

Other

Identifiers

NCT02001779

IR-C-STENT-MBO-83272121

Details and patient eligibility

About

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.

Full 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.

Enrollment

328 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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