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)

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography; Biliary Drainage; Echography Ultrasound
• Interventions: Procedure: EUS guided biliary drainage; Procedure: ERCP

• Registration Number: NCT05122858
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-13
• Primary Completion: 2021-05-13
• Study Completion: 2021-06-14
• Status Verified: 2021-11
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study First Posted: 2021-11-17
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS guided biliary drainage	EUS guided biliary drainage	-
ERCP (Endoscopic Retrograde Cholangiopancreatography	ERCP	-

Primary Outcome Measures

Name	Time	Method
Number of participant with stent dysfunction (obstruction or migration) requiring endoscopic, radiological or surgical intervention	12 months

Trial Locations

Locations (1)

Hôpital Privé des Peupliers; 🇫🇷 Paris, France