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

This study is currently recruiting participants.
Verified September 2012 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
Pramod Kumar Garg, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00391183
First received: October 19, 2006
Last updated: September 2, 2012
Last verified: September 2012
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvements in other functional and social scales and single items of EORTC QLQ-30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cost of therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Performance status change [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: January 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endoscopic stenting
patients with biliary obstruction will undergo endoscopic stenting.
 Procedure: Biliary stenting
ERCP and stenting
No Intervention: Best supportive care

  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:

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

Exclusion Criteria:

  1. Preoperative stenting
  2. ECOG status 4
  3. Distant residence precluding follow up visits, or unwillingness to return for follow up.
  4. 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:

Responsible Party: Pramod Kumar Garg, Additional Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT00391183     History of Changes
Other Study ID Numbers: GE-CAGB/2005
Study First Received: October 19, 2006
Last Updated: September 2, 2012
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

Additional relevant MeSH terms:
Gallbladder Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases

ClinicalTrials.gov processed this record on May 22, 2013