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Above or across? trial tests which stent placement keeps bile flowing longer

NCT ID NCT07811791

Symptom relief Sponsor: National Taiwan University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Cancer near the liver's bile duct junction can block bile flow, causing jaundice and infection. Doctors usually drain the bile with a plastic stent placed through an endoscope. This trial randomly assigns about 70 adults with inoperable high-grade hilar biliary obstruction to one of two stent positions: entirely inside the bile duct above the opening, or across the opening into the intestine. Researchers track how long each stent keeps bile flowing before it blocks again, along with survival and safety.

What this could mean

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

Active substance
plastic biliary stent placement during an endoscopic procedure (ERCP), either above or across the bile duct opening
What this could lead to
If one placement method keeps bile flowing longer, doctors could use it to delay repeat procedures and reduce hospital visits for people with inoperable bile duct cancer.
What could go wrong
Earlier studies comparing these methods gave mixed results, so the difference may be small or absent. Stents can still block or shift, and this trial enrolls only about 70 people with a specific type of blockage.

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 70 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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: * Age 18 years or older * Unresectable high-grade malignant hilar biliary obstruction (Bismuth type II, III, or IV) diagnosed by CT, MRI, and/or previous surgical specimen * Need for biliary drainage due to biliary obstruction (serum total bilirubin ≥2 mg/dL or diagnosis of cholangitis) * Life expectancy greater than 3 months * No stent previously placed in the biliary system * Written informed consent for participation in the study Exclusion Criteria: * Condition not allowing endoscopic intervention * Failed biliary cannulation * Surgically altered anatomy of the upper gastrointestinal tract, excluding Billroth-I reconstruction * Previous endoscopic or surgical ampullectomy, papilloplasty, or surgical bilioenteric anastomosis * Previous placement of external biliary drainage (e.g., percutaneous transhepatic biliary drainage) * Primary sclerosing cholangitis, immunoglobulin G4-associated cholangitis, or primary biliary cholangitis * Pregnancy * Patients who opt for self-paid metal stent placement and are judged suitable for metal stents by the treating physician

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Conditions

The condition(s) this trial relates to.

biliary tract neoplasm Biliary Tract Neoplasms obstructive jaundice

As listed by the trial registrant

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

Biliary drainage Biliary tract neoplasms Malignant biliary obstruction Obstructive jaundice

How to take part

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

  1. The places running it

    8 sites. 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

  • Chung Shan Medical University Hospital

    Taichung, Taiwan

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, Taiwan

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Cancer Center

    Taipei, Taiwan

  • National Taiwan University Hospital (Coordinating Center)

    Taipei, Taiwan

  • National Taiwan University Hospital Hsinchu Branch, Biomedical Park Hospital

    Hsinchu, Taiwan

  • Taipei Tzu Chi Hospital

    New Taipei City, Taiwan

  • Tri-Service General Hospital

    Taipei, Taiwan

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