Active — Not RecruitingNot Applicable

Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents

Sweden450 participantsStarted 2020-02-04

Plain-language summary

The goal of this randomized controlled trial is to compare uncovered, partially covered, and fully covered self-expandable metal stents (SEMS) in the palliative treatment of distal malignant biliary obstruction in a Swedish multicenter study. The main questions it aims to answer is: Is the stent patency rate different depending of stent type? Is the stent patency time different depending of stent type? Is the patient survival different between the groups? Which complications are seen, and do they differ between the groups? Are there different mechanisms behind the stent failure depending on stent type? Patients will at ERCP, with a guidewire passed through the stenosis in the bile duct, be allocated to either uncovered, partially covered, and fully covered (SEMS). Totally, 450 patients will be recruited, 150 in each study arm, according to the power analysis. Patients will be followed in a monthly surveillance by a study nurse up to 12 months after stent insertion. Endpoints are: alive after 12 months with a patent stent, death with a patent stent, stent dysfunction with a subsequent intervention i.e. repeated ERCP or PTC = "objective stent failure", stent dysfunction, jaundice or cholangitis, but not intervention has been undertaken due to a poor condition of the patient, "clinical stent failure", the patient has undergone curative surgery or a bilio-enteric by-pass (a gastro-enteroanastomosis or a duodenal stent is not a reason for exclusion), the patient refuses further follow-up.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient age \> 20 years. * The biliary stenosis located \> 2 cm below the hilum of the liver, and with a malignant appearance. * The patient history, and clinical data supporting a malignant bile duct stenosis. * S-Bilirubin \> 50 μmol/L. * Curative surgery or down-staging not possible due to an advanced decease, or surgery is precluded by high age or co-morbidity. Temporary placement of a plastic endoprosthesis allowed, and after reevaluation within 4 weeks the patient may enter the study. * The patient has received oral and written information about the study and accepted to participate. * CT and/or Ultrasound has been performed. Exclusion Criteria: * Informed consent has not been obtained or denied. * The presence of significant intrahepatic stenoses caused by metastatic disease with also intrahepatic obstruction of the bile flow. A malignant stenosis in the hilum of the liver, or a tumor stricture located \< 2cm below the hilum of the liver. * The patient is probably a candidate for curative surgery or down-staging. * Suspicion of a benign biliary obstruction. * Anatomical situation making ERCP impossible i.e. prior surgical interventions or a tumor stenosis of the duodenum. If the ERCP is not successful at the first attempt a repeated procedure or a PTC rendezvouz is allowed within one week. * Prior biliary drainage (\> 4 weeks earlier). * Increased risk of bleeding (INR \>1.5) * The patient has previously been included in the study.

What they're measuring

Stent patency rate

Timeframe: During the follow-up time from insertion of the SEMS (inclusion of the study) until reaching an endpoint (up to 12 months with a patent stent or until stent failure occurs) the rate of patent SEMS in the three different groups is calculated

Stent patency time

Timeframe: The time, days, of patency of the SEMS during follow-up (up to 12 months) until reaching an endpoint is calculated.

Trial details

NCT IDNCT06453590

SponsorRegion Stockholm

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-01-15

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