NCT01041612

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2010

Typical duration for phase_4

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

December 28, 2009

Last Update Submit

October 19, 2016

Conditions

Cancer of Bile DuctPancreatic Cancer

Keywords

CBDHBDcancer of bile ductpancreatic cancer

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (1)

  • Death of patients

    one year

Study Arms (2)

Group A: C-SEMS, inserted above SO

ACTIVE COMPARATOR

-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

Group B: C-SEMS, inserted across SO

ACTIVE COMPARATOR

-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.

Device: PTFE Covered ComVi [full covered] Biliary Stent

Interventions

PTFE Covered ComVi [full covered] Biliary StentDEVICE

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.

Also known as: PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea
Group A: C-SEMS, inserted above SO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Gifu University

Gifu, Japan

Location

Onomichi General Hospital

Onomichi, Japan

Location

Teine-Keijinkai Hospital

Sapporo, Japan

Location

The University of Tokyo

Tokyo, Japan

Location

Toho University

Tokyo, Japan

Location

Tokyo Medical University

Tokyo, Japan

Location

Yamaguchi University

Ube, Japan

Location

Soon Chun Hyang University School of Medicine

Bucheon-si, South Korea

Location

Soon Chun Hyang University School of Medicine

Cheonan, South Korea

Location

Catholic University of Daegu School of Medicine

Daegu, South Korea

Location

Inha University School of Medicine

Incheon, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Ajou University School of Medicine

Suwon, South Korea

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Bile Duct NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Dong Ki Lee, PH.D

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General manager

Study Record Dates

First Submitted

December 28, 2009

First Posted

January 1, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(6)JP(7)