Clinical Trial: Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer

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

Official Title: Endoscopic Versus Percutaneous Biliary Drainage For Hilar Block Due to Carcinoma Gall Bladder: A Randomized Prospective Trial and Quality Of Life Assessment

Brief Summary: 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.

Detailed Summary:

Hypothesis: Percutaneous biliary stenting is superior to endoscopic stenting in providing successful biliary drainage by 20% in patients with unresectable malignant hilar block due to carcinoma of gall bladder.

Background: Malignant biliary obstruction at the liver hilum is caused by a heterogeneous group of tumours that include cholangiocarcinoma, gallbladder cancer (CaGB) and metastatic cancer. CaGB is the commonest cause of malignant hilar obstruction in India (1). Jaundice is the second most common presentation and occurs in 30-60% of patients with CaGB (2-5). It is obstructive in nature and frequently associated with pruritis, which is very disturbing for the patients. Most patients with CaGB with surgical obstructive jaundice are not amenable to a curative surgical resection (5) and hence effective palliation is the goal of treatment. Although surgical bilioenteric bypass has been the traditional palliative approach (6), it is associated with substantial morbidity and mortality. Non-operative alternatives in the form of percutaneous and endoscopic drainage are available (7-8). Unilateral drainage of single liver lobe may be sufficient to palliate the jaundice and, pruritis and improve the quality of life (9-15). 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 periampullary cancer. However, the scenario is quite different in patients with hilar malignant obstruction. Endoscopic drainage is associated with a higher incidence of cholangitis in patients with a block at the confluence (Bismuth types 2 and 3) 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 hilar
Sponsor: All India Institute of Medical Sciences, New Delhi

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • 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


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

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


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

Dates:
Date Received: December 8, 2006
Date Started: October 2003
Date Completion:
Last Updated: May 25, 2010
Last Verified: December 2006