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New stent technique may lower infection risk in bile duct cancer patients

NCT ID NCT07558304

Symptom relief Sponsor: Hospital de Clinicas de Porto Alegre 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways to drain blocked bile ducts in people with cancer near the liver. One method places a tube across the blockage into the intestine, while the other uses a metal stent that stops short of the intestine. The goal is to see which approach causes fewer complications like infection. About 84 patients will take part, and results could help doctors choose the safest drainage method.

What this could mean

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

Active substance
biliary drainage procedure
What this could lead to
If successful, this study could identify a safer drainage method that reduces infection and other complications for patients with bile duct blockages from cancer.
What could go wrong
This is a small, early-stage trial with only 84 participants, so results may not apply to all patients. Both procedures carry risks like infection or bleeding.

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 84 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 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: 1. Age \>18 years. 2. Malignant proximal biliary obstruction on imaging (magnetic resonance cholangiopancreatography or contrast-enhanced abdominal computed tomography) with histopathological confirmation or high clinical and radiological suspicion. 3. Total bilirubin \> 3 mg/dL. 4. Patients not candidates for potentially curative surgical resection due to locally advanced disease, metastatic disease, or inadequate clinical condition. 5. Patients with potentially resectable neoplasms, defined as the possibility of achieving complete resection (R0), who meet at least one of the following criteria: 5.1 Estimated future liver remnant \<40%, in whom percutaneous portal vein embolization of the side to be resected will also be indicated after initial drainage. 5.2 Prolonged jaundice with total bilirubin \>10 mg/dL for more than 14 days. 5.3 Malnutrition, defined as ≥10% unintentional weight loss or albumin \<3 g/dL, presumably attributable to cholestasis. 5.4 Indication for neoadjuvant chemotherapy. Exclusion Criteria: 1. Tumor with distal extension to the duodenal papilla, precluding suprapapillary drainage. 2. Prior biliary drainage procedure, either percutaneous (PTBD) or endoscopic (ERCP). 3. Acute cholangitis, clinically defined as fever (axillary temperature \>38°C) and leukocytosis (white blood cell count \>10,000/mm³). 4. Uncorrectable coagulopathy. 5. Iodinated contrast allergy not amenable to desensitization.

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Conditions

The condition(s) this trial relates to.

bile duct neoplasm biliary tract cancer cholangiocarcinoma hilar cholangiocarcinoma perihilar intrahepatic cholangiocarcinoma

As listed by the trial registrant

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

Bile duct neoplasms Cholangiocarcinoma Malignant biliary obstruction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.