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

Primary Purpose

Biliary Tract Neoplasms, Pancreatic Neoplasms, Stent Occlusion

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Steel
Nitinol
Sponsored by
Stockholm South General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Neoplasms focused on measuring bile duct obstruction, jaundice, metal stent

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Surgery, Upper GI Div. South Hospital,
  • Sahlgrenska Universitetssjukhuset
  • Länssjukhuset Ryhov
  • Länssjukhuset i Kalmar
  • Blekingesjukhuset
  • Centralsjukhuset i Kristianstad
  • Universitetssjukhuset i Lund
  • Universitetssjukhuset i Malmö,
  • dept surgery, South Hospital-Karolinska Institute
  • Claes.Soderlund
  • Vasteraslasarett

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

steel

Nitinol

Arm Description

Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction

Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction

Outcomes

Primary Outcome Measures

confirmed stent failure

Secondary Outcome Measures

safety with respective stent in trial at insertion and afterwards(complic.)
Survival
Survival difference between two groups

Full Information

First Posted
September 18, 2009
Last Updated
April 5, 2014
Sponsor
Stockholm South General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00980889
Brief Title
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction
Official Title
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stockholm South General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Neoplasms, Pancreatic Neoplasms, Stent Occlusion
Keywords
bile duct obstruction, jaundice, metal stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
steel
Arm Type
Active Comparator
Arm Description
Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction
Arm Title
Nitinol
Arm Type
Active Comparator
Arm Description
Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction
Intervention Type
Device
Intervention Name(s)
Steel
Other Intervention Name(s)
Wallstent®
Intervention Description
ERCP procedure insertion of Metalic Steel Stent, Wallstent®
Intervention Type
Device
Intervention Name(s)
Nitinol
Other Intervention Name(s)
Wallflex
Intervention Description
Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction
Primary Outcome Measure Information:
Title
confirmed stent failure
Time Frame
300 days follow up
Secondary Outcome Measure Information:
Title
safety with respective stent in trial at insertion and afterwards(complic.)
Time Frame
300 days
Title
Survival
Description
Survival difference between two groups
Time Frame
300 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claes soderlund, assist prof
Organizational Affiliation
south hospital, stockholm sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Upper GI Div. South Hospital,
City
Stockholm
State/Province
SLL
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Länssjukhuset Ryhov
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Facility Name
Länssjukhuset i Kalmar
City
Kalmar
ZIP/Postal Code
391 85
Country
Sweden
Facility Name
Blekingesjukhuset
City
Karlskrona
Country
Sweden
Facility Name
Centralsjukhuset i Kristianstad
City
Kristianstad
ZIP/Postal Code
29185
Country
Sweden
Facility Name
Universitetssjukhuset i Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Universitetssjukhuset i Malmö,
City
Malmö
Country
Sweden
Facility Name
dept surgery, South Hospital-Karolinska Institute
City
Stockholm
ZIP/Postal Code
se 118 83
Country
Sweden
Facility Name
Claes.Soderlund
City
Stockholm
ZIP/Postal Code
se 11883
Country
Sweden
Facility Name
Vasteraslasarett
City
Vasteras
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25321620
Citation
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.
Results Reference
derived

Learn more about this trial

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

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