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

University Hospital, Linkoeping1 site in 1 country400 target enrollmentJanuary 2006

ConditionsBile Duct Obstruction Pancreatic Cancer Gallbladder Cancer Bile Duct Cancer

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Bile Duct Obstruction
Sponsor: University Hospital, Linkoeping
Enrollment: 400
Locations: 1
Primary Endpoint: Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

August 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Linkoeping

Eligibility Criteria

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)