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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00391183 |
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Date of registration:
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19/10/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Palliative Biliary Stenting on the Quality of Life of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.
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Scientific title:
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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 |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00391183 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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India
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Contacts
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Name:
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Vikram Bhatia, M.D, D.M. |
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Address:
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Telephone:
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Email:
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Affiliation:
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All India Institute of Medical Sciences, New Delhi |
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Name:
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Pramod Garg, M.D, D.M. |
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Address:
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Telephone:
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Email:
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Affiliation:
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All India Institute of Medical Sciences, New Delhi |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gallbladder Cancer
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Intervention(s)
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Procedure: Biliary stenting
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Primary Outcome(s)
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Improvement in the physical functioning scale (containing five items) of EORTC QLQ-30 one month after after biliary stenting.
[Time Frame: 30 days]
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Secondary Outcome(s)
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Hospital stay
[Time Frame: 30 days]
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Cost of therapy
[Time Frame: 30 days]
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Improvements in other functional and social scales and single items of EORTC QLQ-30
[Time Frame: 30 days]
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Complications
[Time Frame: 30 days]
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Performance status change
[Time Frame: 30 days]
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Survival
[Time Frame: 30 days]
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Secondary ID(s)
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GE-CAGB/2005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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