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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 T

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 Summary:

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 diagnosis and death. Most of these patients suffer from intractable pruritis, pain, anorexia and general debility. Biliary stenting leads to a reduction in pruritis and jaundice, and is commonly offered to many unresectable patients. However stenting related complications like cholangitis, rescue percutaneous treatment and need for prolonged hospitalization often impair the remaining short survival of these patients. In these patients improving the QOL should be the primary focus, and survival a secondary end point in disease management. No study has addressed the issue of QOL of patients with gallbladder cancer, post stenting.

Three clinical studies have evaluated the change in the QOL of patients with malignant biliary obstruction after of endoscopic stenting. Ballinger et al evaluated 19 patients with unresectable pancreatic carcinoma before stenting and upto 12 weeks or death after stenting. The Rotterdam Symptom Checklist and the Hospital Anxiety and Depression Scale were used. Significant improvements were seen in the parameters of mood, indigestion, appetite and level of activity. Luman et al studied 47 inoperable patients with malignant biliary strictures. The European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC QLQ-C30) was used at baseline and 1 month after stenting. For patients successfully completing the follow up, significant improvement in emotional, cognitive , and global health scores was found after stenting. In addition to the expected improvement in pruritis and jaundice , anorexia, diarrhea and sleep pattern were also improved. Abraham et al studied 50 patients with malignant biliary obstruction without liver metastasis considered
Sponsor: All India Institute of Medical Sciences, New Delhi

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

Original Primary Outcome: Improvement in the physical functioning scale (containing five items) of EORTC QLQ-30 one month after after biliary stenting.

Current Secondary Outcome:

  • Improvements in other functional and social scales and single items of EORTC QLQ-30 [ Time Frame: 30 days ]
  • Survival [ Time Frame: 30 days ]
  • Hospital stay [ Time Frame: 30 days ]
  • Cost of therapy [ Time Frame: 30 days ]
  • Complications [ Time Frame: 30 days ]
  • Performance status change [ Time Frame: 30 days ]


Original Secondary Outcome:

  • Improvements in other functional and social scales and single items of EORTC QLQ-30
  • Survival
  • Hospital stay
  • Cost of therapy
  • Complications
  • Performance status change


Information By: All India Institute of Medical Sciences, New Delhi

Dates:
Date Received: October 19, 2006
Date Started: January 2006
Date Completion:
Last Updated: July 10, 2013
Last Verified: July 2013