Clinical trial NCT05122858: 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)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography
Biliary Drainage
Echography Ultrasound
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-11-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participant with stent dysfunction (obstruction or migration) requiring endoscopic, radiological or surgical intervention
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Privé des Peupliers
Study officials:
References: