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)

EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial.

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.

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