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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Cancer of Bile Duct, Pancreatic Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Dong Ki Lee, PH.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gangnam Severance Hospital

Authority:

Korea: Institutional Review Board

Study ID:

RaMM-BO 2.0

NCT ID:

NCT01041612

Start Date:

January 2010

Completion Date:

July 2012

Related Keywords:

  • Cancer of Bile Duct
  • Pancreatic Cancer
  • CBD
  • HBD
  • cancer of bile duct
  • pancreatic cancer
  • Pancreatic Neoplasms
  • Bile Duct Neoplasms

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