Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00409864
First received: December 8, 2006
Last updated: May 25, 2010
Last verified: December 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • Early cholangitis: Occurring within 48 hours to 7 days of the procedure as evidenced by fever, leukocytosis and worsening LFTs. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
  • Procedure-related and 30-day mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Stent patency time will be defined by time to stent occlusion [ Time Frame: 120 days ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 8, 2006
Last Updated: May 25, 2010
Health Authority: India: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 11, 2014