Lab-Grown cells could seal bile leaks without more surgery
NCT ID NCT07214649
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether a patient's own bile duct cells, grown into tiny organoids in a lab, can be used to patch persistent bile leaks after liver surgery. Researchers will take a small bile duct sample during surgery, store it, and if a leak doesn't heal with standard treatments, they'll grow organoids and deliver them to the leak site. The study includes 25 adults and aims to see if the leak closes without further intervention.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- patient-derived bile duct organoids
- What this could lead to
- If it works, this could provide a new way to repair stubborn bile leaks without repeated surgeries or transplants.
- What could go wrong
- This is a small early-phase trial with only 25 people. The organoids may not engraft or fully close the leak, and long-term safety is unknown.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 over 18 years old * Undergone HPB surgical procedure with hepatic duct reconstruction * Presence of anastomotic bile leakage untreatable with radiological or endoscopic approach * Presence of bile duct specimen Exclusion Criteria: * Age under 18 years old * Undergone HPB surgical procedure without hepatic duct reconstruction * Absence of anastomotic bile leakage untreatable with radiological or endoscopic approach * Absence of bile duct specimen
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.