RCT Steel (Wallstent®) Vs Nitinol (Wallflex®) Bile Duct Stent For Palliation Of Malignant Obstruction

Study Overview

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

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.

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.

Biliary Tract Neoplasms
Pancreatic Neoplasms
Stent Occlusion

DEVICE: Steel
DEVICE: Nitinol

Steel vs nitinol

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-09-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-04-05
First Submitted that Met QC Criteria 2009-09-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-04-08
First Posted (ESTIMATED) 2009-09-21	Results First Posted N/A	Last Verified 2014-04

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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®
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

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®

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

Primary Outcome Measures	Measure Description	Time Frame
confirmed stent failure		300 days follow up

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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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.

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.

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Claes soderlund, assist prof, south hospital, stockholm sweden

Publications

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

General Publications

Soderlund C, Linder S, Bergenzaun PE, Grape T, Hakansson HO, Kilander A, Lindell G, Ljungman M, Ohlin B, Nielsen J, Rudberg C, Stotzer PO, Svartholm E, Toth E, Frozanpor F. Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial. Endoscopy. 2014 Nov;46(11):941-8. doi: 10.1055/s-0034-1377936. Epub 2014 Oct 16.

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Clinical Trial Record