Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer

NCT00409864 | Completed

• 1 other identifier: GIS/1/2003
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallbladder Cancer; Obstructive Jaundice

Keywords

Gallbaldder Cancer; Endoscopic stenting; Percutaneous biliary drainage

Outcome Measures

Primary Outcomes (3)

• Successful drainage: A decrease in bilirubin to less than 75% of the pretreatment value within 7 days

  7 days

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

  7 days

• Quality of life

  30 days

Secondary Outcomes (3)

• Complications

  30 day

• Procedure-related and 30-day mortality

  30 days

• Stent patency time will be defined by time to stent occlusion

  120 days

Study Arms (2)

PTBD

ACTIVE COMPARATOR

percutaneous biliary drainage

Procedure: Endoscopic biliary stenting, Percutaneous biliary stenting

Endoscopic stenting

ACTIVE COMPARATOR

ERCP and stenting

Procedure: Endoscopic biliary stenting, Percutaneous biliary stenting

Interventions

Endoscopic biliary stenting, Percutaneous biliary stenting PROCEDURE

percutaneous 10 F stent, endoscopic 10 F stent insertion

Endoscopic stenting; PTBD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences,

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (2)

• Speer AG, Cotton PB, Russell RC, Mason RR, Hatfield AR, Leung JW, MacRae KD, Houghton J, Lennon CA. Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice. Lancet. 1987 Jul 11;2(8550):57-62. doi: 10.1016/s0140-6736(87)92733-4.

  PMID: 2439854 BACKGROUND

• Pinol V, Castells A, Bordas JM, Real MI, Llach J, Montana X, Feu F, Navarro S. Percutaneous self-expanding metal stents versus endoscopic polyethylene endoprostheses for treating malignant biliary obstruction: randomized clinical trial. Radiology. 2002 Oct;225(1):27-34. doi: 10.1148/radiol.2243011517.

  PMID: 12354980 BACKGROUND

MeSH Terms

Conditions

Gallbladder Neoplasms; Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Peush Sahni, MS, PhD

  Dept. of GI Surgery, All India Institute of Medical Sciences, New Delhi, India

  STUDY DIRECTOR

• Sundeep Saluja, MS, MCh

  Dept. of GI Surgery, All India Institute of Medical Sciences, New Delhi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 11, 2006
• Study Start: October 1, 2003
• Primary Completion: July 1, 2005
• Study Completion: December 1, 2005
• Last Updated: May 26, 2010

Record last verified: 2006-12

Locations

IN (1)