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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Stockholm South General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stockholm South General Hospital
ClinicalTrials.gov Identifier:
NCT00980889
First received: September 18, 2009
Last updated: July 25, 2011
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Biliary Tract Neoplasms
Pancreatic Neoplasms
Stents
 Device: Patency of Steel Stent.
Device: Patency of Nitinol Stent, Wallflex®.
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stockholm South General Hospital:

Primary Outcome Measures:
  • stent failure [ Time Frame: 10 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety with respective stent in trial at insertion and afterwards(complic.) [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: May 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction
 Device: Patency of Steel Stent.
ERCP procedure insertion of Metalic Steel Stent, Wallstent®
Other Name: Wallstent
Active Comparator: 2
Nitinol Stent, Wallflex®.
 Device: Patency of Nitinol Stent, Wallflex®.
at ERCP, after Rx,a nitinol stent is inserted.
Other Name: Wallflex

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 10% difference between the 2 groups, regarding patency, 400 patients must be included in the trial, alfa 0.05, beta 0.8. We 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.

We 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980889

Contacts
Contact: Claes Soderlund, assist prof. +4686162329 claes.soderlund@sodersjukhuset.se
Contact: Åsa Jirvelius, coordinator +466162475 asa.jirvelius@sodersjukhuset.se

Locations
Sweden
Department of Surgery, Upper GI Div. South Hospital, Recruiting
Stockholm, SLL, Sweden, 118 83
Contact: Stefan Linder, assist prof     +4686162363     stefan.linder@sodersjukhuset.se    
Contact: Farshad Frozanpor, MD     +4686163695     farshad.frozanpor@sodersjukhuset.se    
Principal Investigator: Claes Söderlund, Assist prof            
Sub-Investigator: Stefan Linder, Assist prof            
Sub-Investigator: Farshad Frozanpor, MD            
Sahlgrenska Universitetssjukhuset Recruiting
Göteborg, Sweden, 41345
Contact: Per-Ove Stotzer, MD         stotzer@vgregion.se    
Sub-Investigator: Per-Ove Stotzer, MD            
Principal Investigator: Anders Killander, MD            
Sub-Investigator: Anders Thune,, MD            
Länssjukhuset Ryhov Recruiting
Jönköping, Sweden, 551 85
Contact: Erik Svartholm, MD         erik.svartholm@lj.se    
Sub-Investigator: Erik Svartholm, MD            
Sub-Investigator: Gunnar Persson, MD            
Länssjukhuset i Kalmar Recruiting
Kalmar, Sweden, 391 85
Contact: Hans-olof Hakansson, MD         hansolofh@ltkalmar.se    
Sub-Investigator: Hans-olof Hakansson, MD            
Sub-Investigator: Peter Möller, MD            
Blekingesjukhuset Recruiting
Karlskrona, Sweden
Contact: Bo Ohlin, MD            
Sub-Investigator: Bo Ohlin, MD            
Centralsjukhuset i Kristianstad Recruiting
Kristianstad, Sweden, 29185
Contact: Tomas Grape, MD         tomas.grape@skane.se    
Sub-Investigator: Tomas Grape, MD            
Universitetssjukhuset i Lund Recruiting
Lund, Sweden, 221 85
Contact: Per Bergenzaun, MD         per.bergenzaun@skane.se    
Sub-Investigator: per Bergenzaun, MD            
Sub-Investigator: Gert Lindell, MD            
Universitetssjukhuset i Malmö, Recruiting
Malmö, Sweden
Contact: Ervin Toth, MD         ervin.toth@med.lu.se    
Sub-Investigator: Edvin Toth, MD            
Claes.Soderlund Recruiting
Stockholm, Sweden, se 11883
Contact: soderlund, MD, PhD         claes.soderlund@sodersjukhuset.se    
Contact: asa jirvelius         asa.jirvelius@sodersjukhuset.se    
Principal Investigator: claes soderlund, md,phd            
dept surgery, South Hospital-Karolinska Institute Recruiting
Stockholm, Sweden, se 118 83
Contact: claes soderlund, MD PhD         claes.soderlund@sodersjukhuset.se    
Contact: asa jirvelius         asa.jirvelius@sodersjukhuset.se    
Vasteraslasarett Recruiting
Vasteras, Sweden
Contact: Martin Ljungman, MD         martin.ljungman@ltv.se    
Contact: Piotr Tracz, MD         piotr.tracz@ltv.se    
Sub-Investigator: Martin Ljungman, MD            
Sub-Investigator: Pitr tracz, MD            
Sponsors and Collaborators
Stockholm South General Hospital
Investigators
Principal Investigator: Claes soderlund, assist prof south hospital, stockholm sweden
  More Information

No publications provided

Responsible Party: PI, Claes Soderlund, assist prof Surgery, South Hospital, Stockholm, dept Surgery, South Hosp. Stockholm, Sweden
ClinicalTrials.gov Identifier: NCT00980889     History of Changes
Other Study ID Numbers: Steel vs nitinol
Study First Received: September 18, 2009
Last Updated: July 25, 2011
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Institutional Review Board

Keywords provided by Stockholm South General Hospital:
bile duct obstruction
jaundice
metal stent

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Biliary Tract Diseases
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013