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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980889
• Other study ID #: Steel vs nitinol
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2009
• Last updated: April 5, 2014
• Start date: May 2009
• Est. completion date: May 2013

Study information

• Verified date: April 2014
• Source: Stockholm South General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Neoplasms
• Pancreatic Neoplasms
• Stent Occlusion

Intervention

Device:
• Steel
ERCP procedure insertion of Metalic Steel Stent, Wallstent®
• Nitinol
Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction

Locations

Country	Name	City	State
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg
Sweden	Länssjukhuset Ryhov	Jönköping
Sweden	Länssjukhuset i Kalmar	Kalmar
Sweden	Blekingesjukhuset	Karlskrona
Sweden	Centralsjukhuset i Kristianstad	Kristianstad
Sweden	Universitetssjukhuset i Lund	Lund
Sweden	Universitetssjukhuset i Malmö,	Malmö
Sweden	Claes.Soderlund	Stockholm
Sweden	Department of Surgery, Upper GI Div. South Hospital,	Stockholm	SLL
Sweden	dept surgery, South Hospital-Karolinska Institute	Stockholm
Sweden	Vasteraslasarett	Vasteras

Sponsors (1)

Lead Sponsor	Collaborator
Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	confirmed stent failure		300 days follow up	No
Secondary	safety with respective stent in trial at insertion and afterwards(complic.)		300 days	Yes
Secondary	Survival	Survival difference between two groups	300 days	Yes