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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer of Bile Duct Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gifu University, Gifu, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTFE Covered ComVi [full covered] Biliary Stent

Device

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

Primary outcomes

Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange

Time frame: one year

Secondary outcomes

Death of patients

Time frame: one year

Sponsors and collaborators

Lead sponsor

Taewoong Medical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jan 1, 2010
Registry last updated: Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed