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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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ClinicalTrials.gov Identifier: NCT00391183
Recruitment Status : Completed
First Posted : October 23, 2006
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Gallbladder Cancer Procedure: Biliary stenting Phase 2 Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2006
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Endoscopic stenting
patients with biliary obstruction will undergo endoscopic stenting.
Procedure: Biliary stenting
ERCP and stenting
No Intervention: Best supportive care


Outcome Measures

Primary Outcome Measures :
  1. Improvement in the physical functioning scale (containing five items) of EORTC QLQ-30 one month after after biliary stenting. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Improvements in other functional and social scales and single items of EORTC QLQ-30 [ Time Frame: 30 days ]
  2. Survival [ Time Frame: 30 days ]
  3. Hospital stay [ Time Frame: 30 days ]
  4. Cost of therapy [ Time Frame: 30 days ]
  5. Complications [ Time Frame: 30 days ]
  6. Performance status change [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: October 23, 2006    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Pramod Kumar Garg, 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 Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases