Clinical trial NCT00980889: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Biliary Tract Neoplasms
Pancreatic Neoplasms
Stent Occlusion
Keywords: bile duct obstruction
jaundice
metal stent
Lead sponsor: Stockholm South General Hospital
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: confirmed stent failure
timeFrame: 300 days follow up
Secondary outcomes:
measure: safety with respective stent in trial at insertion and afterwards(complic.)
timeFrame: 300 days
measure: Survival
timeFrame: 300 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Surgery, Upper GI Div. South Hospital,
state: SLL
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
city: Kalmar
country: Sweden
facility: Länssjukhuset i Kalmar
city: Karlskrona
country: Sweden
facility: Blekingesjukhuset
city: Kristianstad
country: Sweden
facility: Centralsjukhuset i Kristianstad
city: Lund
country: Sweden
facility: Universitetssjukhuset i Lund
city: Malmö
country: Sweden
facility: Universitetssjukhuset i Malmö,
city: Stockholm
country: Sweden
facility: dept surgery, South Hospital-Karolinska Institute
city: Stockholm
country: Sweden
facility: Claes.Soderlund
city: Vasteras
country: Sweden
facility: Vasteraslasarett
Study officials:
affiliation: south hospital, stockholm sweden
name: Claes soderlund, assist prof
role: PRINCIPAL_INVESTIGATOR
References:
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.