Status:
COMPLETED
Palliative Biliary Stenting on the Quality of Life of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Gallbladder Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
For most patients with gallbladder cancer, cure is not possible and treatment should be therefore aimed at palliation of symptoms and maintaining quality of life (QOL) in the few months between diagno...
Eligibility Criteria
Inclusion
- Patients with unresectable gallbladder cancer (Bismuth type II to IV).
- Eastern Cooperative Oncology Group Performance (ECOG) status 0-3.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00391183
Start Date
January 1 2006
End Date
December 1 2012
Last Update
July 11 2013
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, India