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NCT Number: NCT00980889

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.

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Key information

Conditions

Biliary Tract Neoplasms Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hyperbilirubinemia Jaundice Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations Stent Occlusion

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Surgery, Upper GI Div. South Hospital,, Stockholm, SLL, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Steel

Device

ERCP procedure insertion of Metalic Steel Stent, Wallstent®

Other names: Wallstent®

Nitinol

Device

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

Other names: Wallflex

Primary outcomes

  1. confirmed stent failure

    Time frame: 300 days follow up

Secondary outcomes

  1. safety with respective stent in trial at insertion and afterwards(complic.)

    Time frame: 300 days

  2. Survival

    Time frame: 300 days

    Survival difference between two groups

Sponsors and collaborators

Lead sponsor

Stockholm South General Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Sep 21, 2009
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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