Palliative Treatment of Distal Malignant Biliary Obstruction by Endoscopic Stents: Uncovered, Partially Covered, or Fully Covered Metal Stents: a Prospective Randomized Multicenter Study

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Danderyds hospital
RECRUITING
Danderyd
Sahlgrenska University hospital
RECRUITING
Gothenburg
Central Hospital Karlstad
RECRUITING
Karlstad
University Hospital Lund
RECRUITING
Lund
University Hospital Malmö
RECRUITING
Malmö
University Hospital Örebro
RECRUITING
Örebro
Skaraborgs Hospital Skövde
RECRUITING
Skövde
Capio S:t Görans hospital
RECRUITING
Stockholm
Stockholm South Hospital
RECRUITING
Stockholm
University Hospital of Umeå
RECRUITING
Umeå
University hospital Uppsala
RECRUITING
Uppsala
Central Hospital Västerås
RECRUITING
Västerås
Contact Information
Primary
Fredrik Swahn, MD, PhD
fredrik.swahn@ki.se
+46723886818
Backup
Mari Hult, MD, PhD
mari.hult@ki.se
+46707223136
Time Frame
Start Date: 2020-02-04
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 450
Treatments
Experimental: Uncovered SEMS
Allocated to treatment with an uncovered SEMS in the distal bile duct.
Experimental: Partially covered SEMS
Allocated to treatment with a partially covered SEMS in the distal bile duct.
Experimental: Fully covered SEMS
Allocated to treatment with a fully covered SEMS in the distal bile duct.
Sponsors
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov