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

August 9, 2011 updated by: University Hospital, Linkoeping

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linkoping, Sweden, 58185
        • Department of Surgery, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Covered metal stent
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
Active Comparator: 2
Uncovered metal stent
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months after stent insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Study Chair: Eric P Kullman, M.D., Department of Surgery, University Hostpital, Linkoping, Sweden.
  • Principal Investigator: Claes Soderlund, M.D., Department of Surgery, Sodersjukhuset, Stockholm, Sweden.
  • Principal Investigator: Bo Ohlin, M.D., Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden.
  • Principal Investigator: Ervin Toth, M.D., Department of Endoscopy, University Hospital MAS, Malmö, Sweden.
  • Principal Investigator: Carl-Eric Leijonmarck, M.D., Department of Surgery, S:t Goran Hospital, Stockholm, Sweden.
  • Principal Investigator: Eduard Jonas, M.D., Department of Surgery, Danderyd Hospital, Stockholm, Sweden.
  • Principal Investigator: Claes Rudberg, M.D., Department of Surgery, Central Hospital, Vasteras, Sweden.
  • Principal Investigator: Kalev Teder, M.D., Department of Surgery, Central Hospital, Norrkoping, Sweden.
  • Principal Investigator: Erik Svartholm, M.D., Department of Surgery, Ryhov Hospital, Jonkoping, Sweden.
  • Principal Investigator: Mehmet Gozen, M.D., Department of Surgery, Vastervik Hospital, Vastervik, Sweden.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 20, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Estimate)

August 10, 2011

Last Update Submitted That Met QC Criteria

August 9, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELLA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe