Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer
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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 |
- 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 ]
- 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 |
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| India | |
| All India Institute of Medical Sciences, | |
| New Delhi, Delhi, India, 110029 | |
| 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 May 22, 2013