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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
claes soderlund, Stockholm South General Hospital
ClinicalTrials.gov Identifier:
NCT00980889
First received: September 18, 2009
Last updated: April 5, 2014
Last verified: April 2014
  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
Stent Occlusion
Device: Steel
Device: Nitinol
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:


Further study details as provided by Stockholm South General Hospital:

Primary Outcome Measures:
  • confirmed stent failure [ Time Frame: 300 days follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety with respective stent in trial at insertion and afterwards(complic.) [ Time Frame: 300 days ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 300 days ] [ Designated as safety issue: Yes ]
    Survival difference between two groups


Enrollment: 400
Study Start Date: May 2009
Study Completion Date: May 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 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 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.

  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

Locations
Sweden
Department of Surgery, Upper GI Div. South Hospital,
Stockholm, SLL, Sweden, 118 83
Sahlgrenska Universitetssjukhuset
Göteborg, Sweden, 41345
Länssjukhuset Ryhov
Jönköping, Sweden, 551 85
Länssjukhuset i Kalmar
Kalmar, Sweden, 391 85
Blekingesjukhuset
Karlskrona, Sweden
Centralsjukhuset i Kristianstad
Kristianstad, Sweden, 29185
Universitetssjukhuset i Lund
Lund, Sweden, 221 85
Universitetssjukhuset i Malmö,
Malmö, Sweden
Claes.Soderlund
Stockholm, Sweden, se 11883
dept surgery, South Hospital-Karolinska Institute
Stockholm, Sweden, se 118 83
Vasteraslasarett
Vasteras, Sweden
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: claes soderlund, Stockholm South General Hospital
ClinicalTrials.gov Identifier: NCT00980889     History of Changes
Other Study ID Numbers: Steel vs nitinol
Study First Received: September 18, 2009
Last Updated: April 5, 2014
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 April 23, 2014