EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the M… (NCT05122858) | Clinical Trial Compass
CompletedNot Applicable
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)
France15 participantsStarted 2020-11-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ÎĽmol / 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, depr…
What they're measuring
1
Number of participant with stent dysfunction (obstruction or migration) requiring endoscopic, radiological or surgical intervention