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Newer scope technique may outperform standard procedure for Cancer-Related bile duct blockage

NCT ID NCT05122858

Disease control Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial compares two ways to open a blocked bile duct in people with advanced cancer: the standard ERCP procedure versus a newer approach called EUS-guided drainage using a special stent. The goal is to see which method keeps the bile duct open longer with fewer complications. The study enrolls 15 adults with malignant bile duct blockages that cannot be surgically removed.

What this could mean

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

Active substance
EUS-guided biliary drainage with a lumen-apposing metal stent (LAMS) versus ERCP
What this could lead to
If EUS-guided drainage proves safer and more effective, it could become the preferred first-line treatment for malignant bile duct blockages, reducing complications and re-interventions.
What could go wrong
This is a small, early-phase trial with only 15 participants, so results may not apply broadly. Both procedures carry risks like infection, bleeding, or stent failure.

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

15 people

The number who actually took part.

Started

Nov 2020

Finished

Jun 2021

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: * Radiological diagnosis (with or without pathological diagnosis) of a malignant obstruction of the borderline resectable distal bile ducts, locally advanced or unresectable distal to the hilum, at a minimum distance of 2 cm. * Resectability based on tumor staging after axial imaging and evaluation by a physician (surgeon, oncologist and / or gastroenterologist). * High results of the liver function test with a serum bilirubin level at least 3 times above the upper limit of normal (18.9 μmol / L) * Dilated extrahepatic bile duct measuring at least 1.2 cm in axial imaging, ultrasound or endoscopy. * Karnofsky index\> 30% * ASA score \<IV * Patient accepting the constraints of research * Patient affiliated or beneficiary of a social security scheme * Patient having signed an informed consent Exclusion Criteria: * \- Hilar obstruction (biliary obstruction located \<2 cm from the hilum) * Coagulopathy and / or thrombocytopenia that cannot be corrected * Age \<18 years old * Liver metastases involving\> 30% of hepatic volume * Liver cirrhosis with portal hypertension or ascites * Biliary sphincterotomy or placement of a stent performed in the past * Anatomy modified by surgery * Common bile ducts measuring less than 1.2 cm will be excluded. * Patient with clinical and radiological signs of stenosis of the gastric outlet * Patient participating in another clinical study * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * Pregnant, breastfeeding or parturient woman * Patient hospitalized without consent

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As listed by the trial registrant

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

Biliary drainage Echography ultrasound Endoscopic retrograde cholangiopancreatography

Contacts and locations

Locations

  • Hôpital Privé des Peupliers

    Paris, 75013, France

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