Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

Study Overview
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Brief Summary
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The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.

Official Title
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Prospective Randomized Trial Comparing Covered Metal Stents Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction: A Multi-nation, Multi-center Study

Conditions
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Cancer of Bile Duct, Pancreatic Cancer

Intervention / Treatment
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* Device: PTFE Covered ComVi [full covered] Biliary Stent
* Device: PTFE Covered ComVi [full covered] Biliary Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or CBD, >= 18 years old Bile duct or gallbladder cancer invading CBD or distal CHD Pancreatic cancer with mid or distal CBD invasion Cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of Vater. First attempt of endoscopic biliary metallic stenting Negative history of biliary tract surgery Life expectancy at least longer than 4 months (Karnofsky score >60%) Exclusion Criteria: Ampullary cancer Klatskin tumor Combined intrahepatic bile duct cancer Patient with hemobilia Previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 14 days

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: C-SEMS, inserted above SO<br>-In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation. | Device: PTFE Covered ComVi [full covered] Biliary Stent<br>* The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.<br>* Other names: PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea;|
| Active Comparator: Group B: C-SEMS, inserted across SO<br>-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation. | Device: PTFE Covered ComVi [full covered] Biliary Stent<br>* The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.<br>* Other names: PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death of patients |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBD, HBD, cancer of bile duct, pancreatic cancer