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New stent aims to safely unclog bile ducts when standard treatment fails

NCT ID NCT05169398

Symptom relief Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new type of stent designed to drain bile from the liver in patients whose bile ducts are blocked by cancer. The stent is placed using an endoscope guided by ultrasound, without major surgery. The goal is to see if the stent is safe and works well in 20 adults who cannot have the usual ERCP procedure.

What this could mean

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

Active substance
MG-biliary stent (Niti-S)
What this could lead to
If successful, this new stent could provide a safer way to drain bile in patients with cancer-related bile duct blockages when standard methods fail.
What could go wrong
This is a small early study with only 20 participants, so results may not apply to everyone. There is a risk of serious complications 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 20 people

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

Started

Jan 2022

Expected to finish

Nov 2026

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. \>= 18 years of age 2. Anatomically feasible for EUS-guided hepatico-gastrostomy 3. Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis) 4. Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis) 5. Written informed consent (and assent when applicable) obtained from subject. Exclusion Criteria: 1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 2. Coagulopathic patients (INR\>1.5, platelets \<50,000)

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Conditions

The condition(s) this trial relates to.

biliary tract cancer

As listed by the trial registrant

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

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

  • Department of Surgery, Prince of Wales Hospital

    RECRUITING

    Hong Kong, Hong Kong

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