Effect of Palliative Biliary Stenting on the Quality of Life (QOL) of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.

This study is currently recruiting participants.

Verified by All India Institute of Medical Sciences, New Delhi, October 2006

First Received: October 19, 2006 Last Updated: October 23, 2006 History of Changes

Sponsored by:	All India Institute of Medical Sciences, New Delhi
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00391183

Purpose

The purpose of the study is to determine whether palliative biliary stenting improves the quality of life, of gallblader cancer patients, who present with hilar block and obstructive jaundice.

Condition	Intervention	Phase
Gallbladder Cancer	Procedure: Biliary stenting	Phase II Phase III

MedlinePlus related topics: Cancer Gallbladder Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Palliative Biliary Stenting Versus Conservative Treatment on the Quality of Life (QOL) of Patients With Unresectable Carcinoma of the Gallbladder With Hiliar Block: A Randomised Controlled Trial

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:

Improvement in the physical functioning scale (containing five items) of EORTC QLQ-30 one month after after biliary stenting.

Secondary Outcome Measures:

Improvements in other functional and social scales and single items of EORTC QLQ-30
Survival
Hospital stay
Cost of therapy
Complications
Performance status change

Estimated Enrollment:	46
Study Start Date:	January 2006
Estimated Study Completion Date:	November 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with unresectable gallbladder cancer (Bismuth type II to IV).
Eastern Cooperative Oncology Group Performance (ECOG) status 0-3.

Exclusion Criteria:

Preoperative stenting
ECOG status 4
Distant residence precluding follow up visits, or unwillingness to return for follow up.
Poor comprehension of the Hindi QOL questionnaire.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391183

Contacts

Contact: Pramod Garg, M.D, D.M.	9868397205	pgarg10@hotmail.com
Contact: Vikram Bhatia, M.D, D.M.	9818014864	vikrambhatiadr@hotmail.com

Locations

India
All India Institute of Medical Sciences	Recruiting
New Delhi, India

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

Study Director:	Pramod Garg, M.D, D.M.	All India Institute of Medical Sciences, New Delhi
Principal Investigator:	Vikram Bhatia, M.D, D.M.	All India Institute of Medical Sciences, New Delhi

More Information

Additional Information:

Updated cancer treatment guidelines for patients and physicians This link exits the ClinicalTrials.gov site

Publications:

Ballinger AB, McHugh M, Catnach SM, Alstead EM, Clark ML. Symptom relief and quality of life after stenting for malignant bile duct obstruction. Gut. 1994 Apr;35(4):467-70.

Luman W, Cull A, Palmer KR. Quality of life in patients stented for malignant biliary obstructions. Eur J Gastroenterol Hepatol. 1997 May;9(5):481-4.

Abraham NS, Barkun JS, Barkun AN. Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life. Gastrointest Endosc. 2002 Dec;56(6):835-41.

Study ID Numbers:	GE-CAGB/2005
Study First Received:	October 19, 2006
Last Updated:	October 23, 2006
ClinicalTrials.gov Identifier:	NCT00391183 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:

Gallbladder cancer
Quality of life
Stenting
Survival
Performance status

Study placed in the following topic categories:

Gallbladder Diseases
Gall Bladder Cancer
Digestive System Diseases
Digestive System Neoplasms
Biliary Tract Neoplasms

Biliary Tract Diseases
Quality of Life
Gastrointestinal Neoplasms
Gallbladder Neoplasms
Carcinoma

Additional relevant MeSH terms:

Gallbladder Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site

Digestive System Neoplasms
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009