Palliative Biliary Stenting on the Quality of Life of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 19, 2006
CompletedFirst Posted
Study publicly available on registry
October 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 11, 2013
July 1, 2013
6.9 years
October 19, 2006
July 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in the physical functioning scale (containing five items) of EORTC QLQ-30 one month after after biliary stenting.
30 days
Secondary Outcomes (6)
Improvements in other functional and social scales and single items of EORTC QLQ-30
30 days
Survival
30 days
Hospital stay
30 days
Cost of therapy
30 days
Complications
30 days
- +1 more secondary outcomes
Study Arms (2)
Endoscopic stenting
ACTIVE COMPARATORpatients with biliary obstruction will undergo endoscopic stenting.
Best supportive care
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Patients with unresectable gallbladder cancer (Bismuth type II to IV).
- Eastern Cooperative Oncology Group Performance (ECOG) status 0-3.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
All India Institute of Medical Sciences
New Delhi, India
Related Publications (3)
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. doi: 10.1136/gut.35.4.467.
PMID: 7513672BACKGROUNDLuman 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. doi: 10.1097/00042737-199705000-00013.
PMID: 9187881BACKGROUNDAbraham 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. doi: 10.1067/mge.2002.129868.
PMID: 12447294BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pramod Garg, M.D, D.M.
All India Institute of Medical Sciences
- PRINCIPAL INVESTIGATOR
Vikram Bhatia, M.D, D.M.
All India Institute of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Additional Professor
Study Record Dates
First Submitted
October 19, 2006
First Posted
October 23, 2006
Study Start
January 1, 2006
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 11, 2013
Record last verified: 2013-07