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Could a simple stent stop bile leaks after liver surgery?

NCT ID NCT01469442

Disease control Sponsor: University Hospital, Toulouse 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether placing a temporary stent in the bile duct during liver surgery can prevent bile leaks afterward. 304 adults having large liver resections took part. The goal was to see if the stent reduces bile leaks from 15% to 5%.

What this could mean

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

Active substance
external biliary duct stent
What this could lead to
If it works, this could reduce bile leaks after liver surgery, leading to fewer complications and shorter hospital stays.
What could go wrong
This trial is completed but results are not yet widely confirmed. The stent may not work for everyone and could cause its own complications.

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

304 people

The number who actually took part.

Start date

May 2009

Finished

Sep 2017

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: * Subject has given his informed consent and signed consent * Hepatectomy at least 2 segments of liver parenchyma for a benign or malignant disease by laparotomy * Not cirrhotic liver Exclusion Criteria: * Surgery made in emergency * Surgery by laparoscopy * Need to draw up a bilic-digestive anastomosis * Liver cirrhosis * History of cholecystectomy * Resection of less than 2 segments * Preoperative jaundice (total bilirubin\> 30 micromol / l) * Presence of preoperative biliary drainage * Patients requiring the installation of a drain transcystic during the operation

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Conditions

The condition(s) this trial relates to.

Biliary Fistula

As listed by the trial registrant

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

Hepatectomy

Contacts and locations

Locations

  • CHU

    Amiens, 80054, France

  • CHU la conception

    Marseille, 13385, France

  • Hotel Dieu

    Clermont-Ferrand, 63003, France

  • Hotel Dieu

    Nantes, 44093, France

  • Hôpital Claude Huriez

    Lille, 59037, France

  • Hôpital Paul Brousse

    Villejuif, 94804, France

  • Hôpital Saint Antoine

    Paris, 75012, France

  • Hôpital St Eloi

    Montpellier, 34295, France

  • Hôpital beaujon

    Clichy, France, 92118, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Toulouse Purpan

    Toulouse, France, 31000, France

  • hôpital Haute Pierre

    Strasbourg, 67098, France

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