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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980889
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : April 8, 2014
Information provided by (Responsible Party):
claes soderlund, Stockholm South General Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Biliary Tract Neoplasms Pancreatic Neoplasms Stent Occlusion Device: Steel Device: Nitinol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction
Study Start Date : May 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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 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

Primary Outcome Measures :
  1. confirmed stent failure [ Time Frame: 300 days follow up ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00980889

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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
Karlskrona, Sweden
Centralsjukhuset i Kristianstad
Kristianstad, Sweden, 29185
Universitetssjukhuset i Lund
Lund, Sweden, 221 85
Universitetssjukhuset i Malmö,
Malmö, Sweden
dept surgery, South Hospital-Karolinska Institute
Stockholm, Sweden, se 118 83
Stockholm, Sweden, se 11883
Vasteras, Sweden
Sponsors and Collaborators
Stockholm South General Hospital
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Principal Investigator: Claes soderlund, assist prof south hospital, stockholm sweden

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: claes soderlund, Stockholm South General Hospital Identifier: NCT00980889     History of Changes
Other Study ID Numbers: Steel vs nitinol
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014
Keywords provided by claes soderlund, Stockholm South General Hospital:
bile duct obstruction
metal stent
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases