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Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: All India Institute of Medical Sciences, New Delhi
Information provided by: All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT00409864
  Purpose

Cancer of the gallbladder (CaGB) is one of the commonest cause 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

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Cancer    Endoscopy   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Endoscopic Versus Percutaneous Biliary Drainage For Hilar Block Due to Carcinoma Gall Bladder: A Randomized Prospective Trial and Quality Of Life Assessment

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
  • Early cholangitis: Occurring within 48 hours to 7 days of the procedure as evidenced by fever, leukocytosis and worsening LFTs.
  • Quality of life

Secondary Outcome Measures:
  • Complications
  • Procedure-related and 30-day mortality
  • Stent patency time will be defined by time to stent occlusion

Estimated Enrollment:   182
Study Start Date:   October 2003
Estimated Study Completion Date:   February 2006

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409864

Locations
India, Delhi
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:

Study ID Numbers:   GIS/1/2003
First Received:   December 8, 2006
Last Updated:   December 8, 2006
ClinicalTrials.gov Identifier:   NCT00409864
Health Authority:   India: Ministry of Health

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

Study placed in the following topic categories:
Gallbladder Diseases
Biliary Tract Neoplasms
Digestive System Neoplasms
Urinary Bladder Neoplasms
Quality of Life
Gall bladder cancer
Carcinoma
Jaundice, Obstructive
Signs and Symptoms
Digestive System Diseases
Hyperbilirubinemia
Biliary Tract Diseases
Gastrointestinal Neoplasms
Gallbladder Neoplasms
Jaundice
Bladder neoplasm

Additional relevant MeSH terms:
Skin Manifestations
Neoplasms
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on October 15, 2008




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