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

October 19, 2016 updated by: Jong Taek, Lee, Taewoong Medical Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Gifu, Japan
        • Gifu University
      • Onomichi, Japan
        • Onomichi General Hospital
      • Sapporo, Japan
        • Teine-Keijinkai Hospital
      • Tokyo, Japan
        • Tokyo Medical University
      • Tokyo, Japan
        • The University of Tokyo
      • Tokyo, Japan
        • Toho University
      • Ube, Japan
        • Yamaguchi University
  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Soon Chun Hyang University School of Medicine
      • Cheonan, Korea, Republic of
        • Soon Chun Hyang University School of Medicine
      • Daegu, Korea, Republic of
        • Catholic University of Daegu School of Medicine
      • Incheon, Korea, Republic of
        • Inha University School of Medicine
      • Seoul, Korea, Republic of, 135-720
        • Gangnam Severance Hospital
      • Suwon, Korea, Republic of
        • Ajou University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A: C-SEMS, inserted above SO
-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
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.
Other Names:
  • PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea
ACTIVE_COMPARATOR: Group B: C-SEMS, inserted across SO
-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.
Device: PTFE Covered ComVi [full covered] Biliary Stent
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.
Other Names:
  • PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Death of patients
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taewoong Medical Co., Ltd.

Investigators

  • Principal Investigator: Dong Ki Lee, PH.D, Gangnam Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Jung Nam Cho, Jimin Han, Ho Gak Kim, IM Hee Shin, Sang Heum Park, Jong Ho Moon, Jin Hong Kim, Don Haeng Lee, Iruru Maetani, Hiroyuki Maguchi, Keiji Hanada, Ichiro Yasuda, Takao Itoi, Hiroyuki Isayama, Dongki Lee. Prospective Randomized Trial Comparing Covered Metal Stent Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction. Gastrointestinal Endoscopy 77(58): AB139-AB140, 2013

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

December 28, 2009

First Submitted That Met QC Criteria

December 30, 2009

First Posted (ESTIMATE)

January 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RaMM-BO 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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