|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| 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 |
| Estimated Enrollment: | 182 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | February 2006 |
![]() |
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:
Exclusion Criteria:
Contacts and Locations| India, Delhi | |||||
| All India Institute of Medical Sciences, | |||||
| New Delhi, Delhi, India, 110029 | |||||
| All India Institute of Medical Sciences, New Delhi |
| 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
| 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 |
|
|
|
|