RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction

April 5, 2014 updated by: claes soderlund, Stockholm South General Hospital

Less than 20% of patients with malignant distal bile duct (BD) obstruction (often pancreatic cancer) are suitable for resection surgery.In the rest,palliation treatment comes into focus. Jaundice caused by BD obstruction gives pain, infection (cholangitis), often itching and increased weight loss, and the patient is stigmatized by the deep yellow colour of the skin.Therefore palliation with endoscopic stenting by ERCP-technique is important. Modern self-expanding metal stents (SEMS) are now widely used in this context. Comparison in a RCT between steel and nitinol SEMS has never been performed.

The steel stent (Wallstent®) is the "original",is widely used, and has more expanding power. Nitinol stents are softer and claimed to be easier to insert,and are more and more popular.A newly developed nitinol stent (Wallflex®)may have these advantages, but is some 120 Euros more expensive.

Regarding the most important outcome measure, time to stent failure (obstruction), no one knows if there is any difference.Our hypothesis is that there is no difference in this main outcome endpoint.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Secondary outcome measures (compare above) are complications caused by the stent or stent insertion and technical ease to insert the stent. To discover a 12% difference between the 2 groups, regarding patency, 400 patients must be included in the trial, alfa 0.05, beta 0.8. Investigators know from previous trials (Single center trial South Hospital GIE 2006;63:986-995 and a newly finished similar swedish multicenter trial,prel data DDW- 09)that the 9 hospitals recruited will be able to include this no of patients in approximately 2.5 years.

Investigators will have a shortest follow-up period of 10 months, followup will be by phone with standard questions connected to stent failure, which is defined clinically AND by a new ERCP with intervention because of an obstructed stent.

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
      • Göteborg, Sweden, 41345
        • Sahlgrenska Universitetssjukhuset
      • Jönköping, Sweden, 551 85
        • Länssjukhuset Ryhov
      • Kalmar, Sweden, 391 85
        • Länssjukhuset i Kalmar
      • Karlskrona, Sweden
        • Blekingesjukhuset
      • Kristianstad, Sweden, 29185
        • Centralsjukhuset i Kristianstad
      • Lund, Sweden, 221 85
        • Universitetssjukhuset i Lund
      • Malmö, Sweden
        • Universitetssjukhuset i Malmö,
      • Stockholm, Sweden, se 118 83
        • dept surgery, South Hospital-Karolinska Institute
      • Stockholm, Sweden, se 11883
        • Claes.Soderlund
      • Vasteras, Sweden
        • Vasteraslasarett
    • SLL
      • Stockholm, SLL, Sweden, 118 83
        • Department of Surgery, Upper GI Div. South 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:

  • pt more than 20yrs.
  • BD stenosis at least 2cm distal of the hepatic hilum, with typical malignant exposure radiologically.
  • Clinically in accordance with tumour.s-bilirubin more than 50 micromol per litre.
  • Radical surgery probably not possible(temporary-1month-plastic stenting for further investigation and then exchange to SEMS if estimated non-operable, after Rx is allowed).
  • The patient must be fully informed by his doctor orally and in writing prior to the procedure, and give her/his informed consent. Ultrasound or CT examination must be performed prior to Rx.

Exclusion Criteria:

  • Informed consent not obtained.
  • Significant multiple intrahepatic stenosis by multiple tumour growth, not suitable for ERCP stenting.
  • Radical Surgery will probably take place. Suspicion of non-malignant obstruction-further investigation must be performed.
  • Not possible by anatomical reasons to reach the papilla, i.e because of prior operations.

prior BD stent inserted (metal stent or plastic stent >1month).

  • Previously included in this trial. Prothrombin index more than 1.5. (normal <1.1).

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: steel
Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction
Device: Steel
ERCP procedure insertion of Metalic Steel Stent, Wallstent®
Other Names:
  • Wallstent®
Active Comparator: Nitinol
Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction
Device: Nitinol
Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction
Other Names:
  • Wallflex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
confirmed stent failure
Time Frame: 300 days follow up
300 days follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety with respective stent in trial at insertion and afterwards(complic.)
Time Frame: 300 days
300 days
Survival
Time Frame: 300 days
Survival difference between two groups
300 days

Collaborators and Investigators

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

Sponsor

Stockholm South General Hospital

Investigators

  • Principal Investigator: Claes soderlund, assist prof, south hospital, stockholm 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

May 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 5, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Steel vs nitinol

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.

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