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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00280709

Enrollment

400

Registered

2006-01-23

Start date

2006-01-31

Completion date

2010-08-31

Last updated

2011-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Cancer, Bile Duct Obstruction, Gallbladder Cancer, Pancreatic Cancer

Keywords

Bile duct, Bile duct obstruction, Biliary stent, Metal stent, ERCP, Patency, Complication, Stent occlusion

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.

Interventions

DEVICENitinella ; 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026