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Which stent lasts longest? a Head-to-Head test for bile duct blockage

NCT ID NCT06453590

Disease control Sponsor: Region Stockholm Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is testing three types of metal stents used to relieve jaundice in people with advanced cancer blocking the bile duct. The stents – uncovered, partially covered, or fully covered – are placed during an endoscopic procedure to keep the duct open. The study will compare how long each stent stays functional, patient survival, and complication rates. The goal is to find which stent type offers the best, longest-lasting relief for those who cannot have surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endoscopic placement of self-expandable metal stents (SEMS) – either uncovered, partially covered, or fully covered – to relieve bile duct blockage.
What this could lead to
If one stent type proves more durable, it could improve quality of life and reduce the need for repeat procedures in people with advanced bile duct cancer.
What could go wrong
This is a randomized trial, but results may vary by patient. Stents can fail due to blockage or migration, and the best type may not be clearly superior.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bile duct cancer bile duct neoplasm carcinoma of duodenum duodenum cancer malignant pancreatic neoplasm papillary carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bile duct cancer Duodenal cancer Pancreatic cancer non-resectable Papillary carcinoma

Contacts and locations

Locations

  • Capio S:t Görans hospital

    Stockholm, 112 19, Sweden

  • Central Hospital Karlstad

    Karlstad, 652 40, Sweden

  • Central Hospital Västerås

    Västerås, 721 89, Sweden

  • Danderyds hospital

    Danderyd, 18288, Sweden

  • Sahlgrenska University hospital

    Gothenburg, 413 45, Sweden

  • Skaraborgs Hospital Skövde

    Skövde, 549 49, Sweden

  • Stockholm South Hospital

    Stockholm, 118 83, Sweden

  • University Hospital Lund

    Lund, 222 42, Sweden

  • University Hospital Malmö

    Malmö, 214 28, Sweden

  • University Hospital of Umeå

    Umeå, 901 85, Sweden

  • University Hospital Örebro

    Örebro, 701 85, Sweden

  • University hospital Uppsala

    Uppsala, 751 85, Sweden

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