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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01041612

Enrollment

120

Registered

2010-01-01

Start date

2010-01-31

Completion date

2012-09-30

Last updated

2016-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Bile Duct, Pancreatic Cancer

Keywords

CBD, HBD, cancer of bile duct, pancreatic cancer

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.

Interventions

DEVICEPTFE 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Death of patients	one year

Countries

Japan, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026