NCT00280709

Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction

Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.

Conditions

• Bile Duct Obstruction
• Pancreatic Cancer
• Gallbladder Cancer
• Bile Duct Cancer

Interventions

Type	Name	Description
DEVICE	"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)	Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-10-01
• Completion: 2010-08-01
• First posted: 2006-01-23
• Last updated: 2011-08-10

Locations

1 site across 1 country: Sweden