NCT06453590Active, not recruiting
Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
Palliative Treatment of Distal Malignant Biliary Obstruction by Endoscopic Stents: Uncovered, Partially Covered, or Fully Covered Metal Stents: A Prospective Randomized Multicenter Study
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 28 May 2024
- Start date
- Feb 2020
- Primary completion date
- Jan 2027
- Lead sponsor
- Region Stockholm
- NCT number
- NCT06453590
What you commit to
- Study type: Interventional
- Planned participants: 450
- From Feb 2020 to the primary completion date, Jan 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient is probably a candidate for curative surgery or down-staging.
- 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).
- The patient has previously been included in the study.
Other illness
- 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.
Lab values
- Increased risk of bleeding (INR \>1.5)
Other
- Informed consent has not been obtained or denied.
- Suspicion of a benign biliary obstruction.
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Danderyds hospital Coordinator of this site? Confirm its status | Danderyd | Sweden | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Central Hospital Karlstad Coordinator of this site? Confirm its status | Karlstad | Sweden | Unknown status |
| University Hospital Lund Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| University Hospital Malmö Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| University Hospital Örebro Coordinator of this site? Confirm its status | Örebro | Sweden | Unknown status |
| Skaraborgs Hospital Skövde Coordinator of this site? Confirm its status | Skövde | Sweden | Unknown status |
| Capio S:t Görans hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Stockholm South Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| University Hospital of Umeå Coordinator of this site? Confirm its status | Umeå | Sweden | Unknown status |
| University hospital Uppsala Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
| Central Hospital Västerås Coordinator of this site? Confirm its status | Västerås | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.