Know Cancer

forgot password

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

Phase 4
20 Years
Open (Enrolling)
Biliary Tract Neoplasms, Pancreatic Neoplasms, Stents

Thank you

Trial Information

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

Secondary outcome measures (compare above) are complications caused by the stent or stent
insertion and technical ease to insert the stent. To discover a 10% difference between the 2
groups, regarding patency, 400 patients must be included in the trial, alfa 0.05, beta 0.8.
We 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.

We 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.

Inclusion Criteria:

- pt more than 20yrs.

- BD stenosis at least 2cm distal of the hepatic hilum, with typical malignant exposure

- 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

- 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

prior BD stent inserted (metal stent or plastic stent >1month).

- Previously included in this trial. Prothrombin index more than 1.5. (normal <1.1).

Type of Study:


Study Design:

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

Outcome Measure:

stent failure

Outcome Time Frame:

10 months follow up

Safety Issue:


Principal Investigator

Claes soderlund, assist prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

south hospital, stockholm sweden


Sweden: Regional Ethical Review Board

Study ID:

Steel vs nitinol



Start Date:

May 2009

Completion Date:

November 2012

Related Keywords:

  • Biliary Tract Neoplasms
  • Pancreatic Neoplasms
  • Stents
  • bile duct obstruction
  • jaundice
  • metal stent
  • Biliary Tract Neoplasms
  • Neoplasms
  • Pancreatic Neoplasms