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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Biliary Obstruction

Intervention / Treatment
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* Device: Biliary SEMS loaded with 125I seeds
* Device: Conventional biliary SEMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant biliary obstruction, Obstruction/stricture, Stent, Brachytherapy, Bile duct