Bile duct device study pulled before it began
NCT ID NCT06666699
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study was designed to test a new device for accessing the bile duct in patients with bile duct blockages caused by cancer. The goal was to see if the device could safely and effectively help drain the bile. However, the study was withdrawn before any patients were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EUS access device
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.
- Expected to start
-
Aug 2025
An estimate. Start dates often move.
- Expected to finish
-
May 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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
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Anyone
- Healthy volunteers
-
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: * Patient with malignant biliary obstruction and who is indicated to receive EUS-guided hepaticogastrostomy for biliary drainage, as documented by dilated left hepatic duct and hyperbilirubinemia * Patient who failed ERCP (e.g., inability to access the obstructed biliary system via a transpapillary route) or for whom ERCP is not an option (e.g., due to altered anatomy, gastric outlet obstruction) * 18 years of age or older * Patient willing and able to provide written informed consent and comply with specified study visits Exclusion Criteria: * Patient whose general medical condition and degree of respiratory failure would not allow them to tolerate endoscopy and/or the manipulation required to perform the study procedure * Abnormal coagulopathy: * INR \>1.5 and not correctable * presence of bleeding disorder * platelets \<50,000 mm3 * Patient with contraindication to use of electrical devices * Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study * Patient from a vulnerable population * Current participation in another investigational drug or device study that could interfere with the endpoints of this study
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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.
Contacts and locations
Locations
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Asian Institute of Gastroenterology
Hyderabad, Telangana, 500032, India
-
Georges Pompidou European Hospital
Paris, 75015, France
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Ghent University Hospital
Ghent, 9000, Belgium
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Other studies related to the condition(s) this trial covers.
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