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

Phase 4

Completed

• Conditions: Cancer of Bile Duct; Pancreatic Cancer
• Interventions: Device: PTFE Covered ComVi [full covered] Biliary Stent

• Registration Number: NCT01041612
• Lead Sponsor: Taewoong Medical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-28
• Study First Submitted QC: 2009-12-30
• Study Start: 2010-01
• Study First Posted: 2010-01-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A: C-SEMS, inserted above SO	PTFE Covered ComVi [full covered] Biliary Stent	-In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation.
Group B: C-SEMS, inserted across SO	PTFE Covered ComVi [full covered] Biliary Stent	-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.

Primary Outcome Measures

Name	Time	Method
Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange	one year

Secondary Outcome Measures

Name	Time	Method
Death of patients	one year

Trial Locations

Locations (12)

The University of Tokyo; 🇯🇵 Tokyo, Japan

Onomichi General Hospital; 🇯🇵 Onomichi, Japan

Yamaguchi University; 🇯🇵 Ube, Japan

Gifu University; 🇯🇵 Gifu, Japan

Tokyo Medical University; 🇯🇵 Tokyo, Japan

Teine-Keijinkai Hospital; 🇯🇵 Sapporo, Japan

Toho University; 🇯🇵 Tokyo, Japan

Soon Chun Hyang University School of Medicine; 🇰🇷 Cheonan, Korea, Republic of

Inha University School of Medicine; 🇰🇷 Incheon, Korea, Republic of

Ajou University School of Medicine; 🇰🇷 Suwon, Korea, Republic of

Catholic University of Daegu School of Medicine; 🇰🇷 Daegu, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of