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Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409864
First Posted: December 11, 2006
Last Update Posted: May 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
All India Institute of Medical Sciences, New Delhi
  Purpose
Cancer of the gallbladder (CaGB) is one of the most common causes of malignant obstructive jaundice. Jaundice is the second most common presentation and occurs in 30-60% of patients with CaGB. It is obstructive in nature and frequently associated with pruritus, which is very disturbing for the patients. The usual mechanism of obstruction is direct infiltration of the bile duct by the tumour. Most patients with CaGB with obstructive jaundice are not amenable to a curative surgical resection and hence effective palliation is the goal of treatment. Although surgical bypass has been the traditional palliative approach, it is associated with substantial morbidity and mortality. Non-operative alternatives in the form of percutaneous and endoscopic drainage are available. A few trials have shown that endoscopic drainage is better than percutaneous drainage in patients with lower end bile duct obstruction due to pancreatic and peri-ampullary cancer. However, the scenario is quite different in patients with upper end of bile duct obstruction as occurs due to CaGB. Endoscopic drainage is associated with a higher incidence of cholangitis in patients with a block at the upper end of the bile duct and the success rate varies from 40% to 80%, while percutaneous drainage may be associated with complications such as biliary leak and bleeding. There has been no randomized trial comparing endoscopic and percutaneous drainage in patients with malignant obstruction due to CaGB. The objective of the present study is to carry out a randomized prospective trial comparing percutaneous and endoscopic biliary drainage in patients with CaGB with obstructive jaundice and to assess their quality of life.

Condition Intervention
Gallbladder Cancer Obstructive Jaundice Procedure: Endoscopic biliary stenting, Percutaneous biliary stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Versus Percutaneous Biliary Drainage For Hilar Block Due to Carcinoma Gall Bladder: A Randomized Prospective Trial and Quality Of Life Assessment

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Successful drainage: A decrease in bilirubin to less than 75% of the pretreatment value within 7 days [ Time Frame: 7 days ]
  • Early cholangitis: Occurring within 48 hours to 7 days of the procedure as evidenced by fever, leukocytosis and worsening LFTs. [ Time Frame: 7 days ]
  • Quality of life [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 30 day ]
  • Procedure-related and 30-day mortality [ Time Frame: 30 days ]
  • Stent patency time will be defined by time to stent occlusion [ Time Frame: 120 days ]

Estimated Enrollment: 182
Study Start Date: October 2003
Study Completion Date: December 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PTBD
percutaneous biliary drainage
Procedure: Endoscopic biliary stenting, Percutaneous biliary stenting
percutaneous 10 F stent, endoscopic 10 F stent insertion
Active Comparator: Endoscopic stenting
ERCP and stenting
Procedure: Endoscopic biliary stenting, Percutaneous biliary stenting
percutaneous 10 F stent, endoscopic 10 F stent insertion

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CaGB with hilar block not suitable for curative resection with one or more of the following criteria:

    • Jaundice with serum bilirubin >10 mg/dl,
    • Pruritus,
    • Cholangitis

Exclusion Criteria:

  • Poor performance status: Karnofsky index < 60,
  • Type 1 and 4 hilar block,
  • Uncontrolled ascites,
  • Duodenal obstruction,
  • Patients who opted for insertion of a metallic stent.
  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): NCT00409864


Locations
India
All India Institute of Medical Sciences,
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Director: Peush Sahni, MS, PhD Dept. of GI Surgery, All India Institute of Medical Sciences, New Delhi, India
Principal Investigator: Sundeep Saluja, MS, MCh Dept. of GI Surgery, All India Institute of Medical Sciences, New Delhi
  More Information

Publications:
Responsible Party: VP Gupta, A.I.I.M.S.
ClinicalTrials.gov Identifier: NCT00409864     History of Changes
Other Study ID Numbers: GIS/1/2003
First Submitted: December 8, 2006
First Posted: December 11, 2006
Last Update Posted: May 26, 2010
Last Verified: December 2006

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Gallbaldder Cancer
Endoscopic stenting
Percutaneous biliary drainage

Additional relevant MeSH terms:
Gallbladder Neoplasms
Jaundice
Jaundice, Obstructive
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms