Comparing different types of metal stents for treating bile duct obstruction
Palliative Treatment of Distal Malignant Biliary Obstruction by Endoscopic Stents: Uncovered, Partially Covered, or Fully Covered Metal Stents: a Prospective Randomized Multicenter Study
This study is testing which type of metal stent works best to relieve jaundice in patients with bile duct obstruction caused by cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 12 sites (Danderyd and 11 other locations) |
| Trial ID | NCT06453590 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of uncovered, partially covered, and fully covered self-expandable metal stents (SEMS) in providing palliative treatment for distal malignant biliary obstruction caused by various cancers. A total of 450 patients will be randomly assigned to one of the three stent types during an endoscopic retrograde cholangiopancreatography (ERCP) procedure. The study will evaluate stent patency rates, survival outcomes, and complications associated with each stent type over a follow-up period of up to 12 months. The goal is to determine which stent type offers the best relief from jaundice and the longest duration of effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 20 years old with malignant bile duct stenosis located more than 2 cm below the liver hilum and who are not candidates for curative surgery.
Not a fit: Patients with significant intrahepatic stenoses or those with tumors located less than 2 cm below the hilum of the liver may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of jaundice and better quality of life for patients with malignant biliary obstruction.
How similar studies have performed: Previous studies have shown varying success with different types of stents in similar contexts, but this trial aims to provide more definitive comparisons.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Danderyd and 11 other locations
- Danderyds hospital — Danderyd, Sweden (Recruiting)
- Sahlgrenska University hospital — Gothenburg, Sweden (Recruiting)
- Central Hospital Karlstad — Karlstad, Sweden (Recruiting)
- University Hospital Lund — Lund, Sweden (Recruiting)
- University Hospital Malmö — Malmö, Sweden (Recruiting)
- Skaraborgs Hospital Skövde — Skövde, Sweden (Recruiting)
- Capio S:t Görans hospital — Stockholm, Sweden (Recruiting)
- Stockholm South Hospital — Stockholm, Sweden (Recruiting)
- University Hospital of Umeå — Umeå, Sweden (Recruiting)
- University hospital Uppsala — Uppsala, Sweden (Recruiting)
- Central Hospital Västerås — Västerås, Sweden (Recruiting)
- University Hospital Örebro — Örebro, Sweden (Recruiting)
Study contacts
- Principal investigator: Stefan Linder, MD, PhD — Karolinska university hospital, Karolinska Institutet, Stockholm, Sweden.
- Study coordinator: Fredrik Swahn, MD, PhD
- Email: fredrik.swahn@ki.se
- Phone: +46723886818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.