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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)

About this trial

This is an interventional treatment trial for Bile Duct Obstruction focused on measuring Bile duct, Bile duct obstruction, Biliary stent, Metal stent, ERCP, Patency, Complication, Stent occlusion

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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)

Sites / Locations

Department of Surgery, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

1

2

Arm Description

Covered metal stent

Uncovered metal stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00280709

First Posted

January 20, 2006

Last Updated

August 9, 2011

Sponsor

University Hospital, Linkoeping

1. Study Identification

Unique Protocol Identification Number

NCT00280709

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Active Comparator

Arm Description

Covered metal stent

Arm Title

2

Arm Type

Active Comparator

Arm Description

Uncovered metal stent

Intervention Type

Device

Intervention Name(s)

"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)

Intervention Description

Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm

Primary Outcome Measure Information:

Title

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

Time Frame

12 months after stent insertion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

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)

Overall Study Officials: