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

This study has been completed.
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: July 10, 2013
Last verified: July 2013
  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:


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 ]

Enrollment: 60
Study Start Date: January 2006
Study Completion Date: December 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
All India Institute of Medical Sciences
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:
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: July 10, 2013
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
Biliary Tract Diseases
Biliary Tract Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gallbladder Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2014