Bile infection test could guide stent timing, prevent repeat illness
NCT ID NCT07379749
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at 140 adults who need a plastic stent to open a blocked bile duct. If their bile has bacteria, they are randomly assigned to have the stent replaced after 1 month instead of the usual 3 months. The goal is to see if earlier replacement lowers the chance of the stent clogging and causing a serious bile duct infection.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
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 years and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * All patients between 18 and 90 years old with native papilla and obstructive jaundice of any etiology requiring plastic biliary stent placement, with a positive bile culture at index ERCP who can provide written informed consent (obtained from the patient or legal caregiver). Exclusion Criteria: * prior ERCP attempts * patients with bilio-digestive surgical or endoscopic anastomoses * inability to provide informed consent due to cognitive, legal, or medical reasons * scheduled surgical resection within one month after ERCP.
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Conditions
The condition(s) this trial relates to.
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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Colentina Clinical Hospital
Bucharest, Bucharest, 021025, Romania
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Above or across? trial tests which stent placement keeps bile flowing longer
- Ultrasound inside the body reveals how tumors block the bile duct
- New index aims to better measure bile duct infection treatment outcomes
- New oxygen method may prevent dangerous drops during ERCP
- Anesthesia choice may impact ERCP outcomes in jaundice patients
- New drug may shorten jaundice in gallstone patients