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

September 18, 2009
April 5, 2014
May 2009
June 2012   (final data collection date for primary outcome measure)
confirmed stent failure [ Time Frame: 300 days follow up ] [ Designated as safety issue: No ]
stent failure [ Time Frame: 10 months follow up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00980889 on ClinicalTrials.gov Archive Site
  • 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
safety with respective stent in trial at insertion and afterwards(complic.) [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Biliary Tract Neoplasms
  • Pancreatic Neoplasms
  • Stent Occlusion
  • Device: Steel
    ERCP procedure insertion of Metalic Steel Stent, Wallstent®
    Other Name: Wallstent®
  • Device: Nitinol
    Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction
    Other Name: Wallflex
  • Active Comparator: steel
    Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction
    Intervention: Device: Steel
  • Active Comparator: Nitinol
    Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction
    Intervention: Device: Nitinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
May 2013
June 2012   (final data collection date for primary outcome measure)

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).
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00980889
Steel vs nitinol
Yes
claes soderlund, Stockholm South General Hospital
Stockholm South General Hospital
Not Provided
Principal Investigator: Claes soderlund, assist prof south hospital, stockholm sweden
Stockholm South General Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP