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

Phase 4

Completed

• Conditions: Bile Duct Obstruction; Pancreatic Cancer; Gallbladder Cancer; Bile Duct Cancer
• Interventions: Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)

• Registration Number: NCT00280709
• Lead Sponsor: University Hospital, Linkoeping

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-20
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-23
• Primary Completion: 2008-10
• Study Completion: 2010-08
• Status Verified: 2010-12
• Last Update Submitted: 2011-08-09
• Last Update Posted: 2011-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 20 years of age or older
• oral and written information given and informed consent obtained
• clinical data in accordance with malignant bile duct obstruction
• ultrasonography signs of extrahepatic malignant common bile duct obstruction
• typical radiological findings at ERCP of malignant common bile duct stenosis
• proximal margin of the bile duct stenosis at least 2 cm from the hepatic confluence
• bilirubin > 50 micromol/L
• radical surgery estimated not possible (temporary stenting with insertion of a plastic stent can be obtained but should be replaced by a metal stent within 4 weeks after the first ERCP procedure, and the patient is randomized at the time of insertion of the metal stent)

Exclusion Criteria

• patients with active hepatitis or other hepatic diseases that may cause jaundice
• informed consent not obtained
• metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria)
• the patient is probably a candidate for surgical resection
• suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
• the proximal end of the stenosis is located within 2 cm from the hepatic confluence
• the patient has previously undergone BII or Roux-en-Y gastric resection, or has a significant duodenal obstruction making ERCP difficult
• previously (more than 4 weeks earlier) treated with a bile duct stent
• severe coagulation disturbance (PK-INR > 1.6)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)	Covered metal stent
2	"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)	Uncovered metal stent

Primary Outcome Measures

Name	Time	Method
Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?	12 months after stent insertion

Trial Locations

Locations (1)

Department of Surgery, University Hospital; 🇸🇪 Linkoping, Sweden