Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across The Sphincter Of Oddi

Study Overview

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

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.

N/A

Cancer of Bile Duct
Pancreatic Cancer

DEVICE: PTFE Covered ComVi [full covered] Biliary Stent
DEVICE: PTFE Covered ComVi [full covered] Biliary Stent

RaMM-BO 2.0

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-12-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-10-19
First Submitted that Met QC Criteria 2009-12-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-10-21
First Posted (ESTIMATED) 2010-01-01	Results First Posted N/A	Last Verified 2016-10

Study Plan

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

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.
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.

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.

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.

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

Secondary Outcome Measures	Measure Description	Time Frame
Death of patients		one year

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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%)

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Dong Ki Lee, PH.D, Gangnam Severance Hospital

Publications

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

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Resources

PatientS

Caregivers

Clinical Trial Record