EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction (AXIOS-CPRE)

Ramsay Générale de Santé

Status

Completed

Conditions

Endoscopic Retrograde Cholangiopancreatography

Echography Ultrasound

Biliary Drainage

Treatments

Procedure: EUS guided biliary drainage

Procedure: ERCP

Study type

Interventional

Funder types

Other

Identifiers

NCT05122858

2020-A00654-35

Details and patient eligibility

About

The main objective is to compare the EUS-BD with the insertion of a LAMS vs. traditional ERCP to restore biliary patency. Although ERCP has been the primary treatment for many years, it is associated with a significant risk of procedural complications and possible stent blockage. EUS-BD has been shown to be potentially safer and is associated with a lower risk of stent blockage. We seek with our study to determine whether EUS-BD may be the most effective treatment modality.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Radiological diagnosis (with or without pathological diagnosis) of a malignant obstruction of the borderline resectable distal bile ducts, locally advanced or unresectable distal to the hilum, at a minimum distance of 2 cm.
Resectability based on tumor staging after axial imaging and evaluation by a physician (surgeon, oncologist and / or gastroenterologist).
High results of the liver function test with a serum bilirubin level at least 3 times above the upper limit of normal (18.9 μmol / L)
Dilated extrahepatic bile duct measuring at least 1.2 cm in axial imaging, ultrasound or endoscopy.
Karnofsky index> 30%
ASA score <IV
Patient accepting the constraints of research
Patient affiliated or beneficiary of a social security scheme
Patient having signed an informed consent

Exclusion criteria

- Hilar obstruction (biliary obstruction located <2 cm from the hilum)
Coagulopathy and / or thrombocytopenia that cannot be corrected
Age <18 years old
Liver metastases involving> 30% of hepatic volume
Liver cirrhosis with portal hypertension or ascites
Biliary sphincterotomy or placement of a stent performed in the past
Anatomy modified by surgery
Common bile ducts measuring less than 1.2 cm will be excluded.
Patient with clinical and radiological signs of stenosis of the gastric outlet
Patient participating in another clinical study
Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Pregnant, breastfeeding or parturient woman
Patient hospitalized without consent