Status:
UNKNOWN
Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis
Lead Sponsor:
Frederic PRAT, MD, PhD
Conditions:
Malignant Biliary Stenosis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 3...
Eligibility Criteria
Inclusion
- Presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts
- Presence of clinical jaundice and / or biological cholestasis (GGT\> 3N)
- Absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal CT scan, MRI with biliary sequences.
- Endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion.
- No history of ERCP in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion
- Collegial validation of the need for a formal diagnosis of indeterminate biliary stenosis in order to guide therapeutic management
- Patients aged 18 to 85
- Patient who gave his consent to participate in the study
- No contraindication to anesthesia (ASA 1, 2,3)
- Patient affiliated to a social security scheme (beneficiary or beneficiary)
- Absence of pregnancy and current contraception in women of childbearing age
Exclusion
- Presence of a manifest tissue mass in relation to the biliary stenosis on CT and / or MRI imaging.
- Very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity
- History of ERCP and / or percutaneous biliary drainage in the 6 months preceding inclusion
- Presence of a plastic or metal biliary prosthesis in place at the time of inclusion
- History of cephalic duodeno-pancreatectomy or hepatico-jejunal anastomosis
- Non-passable stenosis of the main bile duct
- Severe coagulopathy, thrombocytopenia \<75,000 G / L, treatment with clopidogrel cannot be interrupted even temporarily
- Anesthetic contraindication (ASA 4)
- Inability to obtain informed consent
- person deprived of liberty
Key Trial Info
Start Date :
December 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 26 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04840537
Start Date
December 26 2018
End Date
December 26 2022
Last Update
April 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Beaujon
Clichy, France, 92110