A Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

Study Overview
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Brief Summary
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Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. Biliary drainage and stent patency was a little superior in side by side than stent in stent. But, complication related with bilateral metal stent was increased in patients with side by side method. Another study showed that there was no significant difference between those bilateral stent insertion methods. The most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial. The purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD type) in patient with hilar malignant biliary obstruction.

Official Title
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A Prospective Randomized Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

Conditions
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HCC, Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer, AOV Cancer

Intervention / Treatment
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* Procedure: side by side
* Procedure: stent in stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction older than 20 years old Exclusion Criteria: Operable case Non-hilar biliary malignant obstruction Duodenal obstruction Other cancer except biliary malignancy uncontrolled infection status Eastern Cooperative Oncology Group ≥ 3 No signed informed consent Failed endoscopic approach to duodenum or biliary tract

Ages Eligible for Study
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Minimum Age: 20 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: Side by side group<br> | Procedure: side by side<br>* Stenting generally begins with selective guidewire cannulation into the left and right intrahepatic bile ducts. Self-expandable metallic stent(SEMS) deployment is the conventional method and parallel SEMS can be inserted. SEMS deployment can be performed serially or simultaneously.<br>|
| Active Comparator: Stent in stent group<br> | Procedure: stent in stent<br>* After first SEMS deployment, contralateral placement of a second SEMS through the mesh of the first deployed stent was done and it looks like a Y configuration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median patency duration | Median patency duration from stent insertion date to stent occlusion date or last follow up date if stent is patent | 1 year after stent insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 
| complication rate |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hilar malignant biliary obstruction, bilateral metal stent, stent in stent, side by side