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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280709
• Other study ID #: ELLA
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2006
• Last updated: August 9, 2011
• Start date: January 2006
• Est. completion date: August 2010

Study information

• Verified date: December 2010
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Obstruction
• Cholangiocarcinoma
• Cholestasis
• Gallbladder Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Sweden	Department of Surgery, University Hospital	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?		12 months after stent insertion	Yes