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)

Sponsor

Ramsay Générale de Santé (Other)

Overall Status

Completed

CT.gov ID

NCT05122858

Collaborator

European Clinical Trial Experts Network (Other)

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography Biliary Drainage Echography Ultrasound	Procedure: EUS guided biliary drainage Procedure: ERCP	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Nov 13, 2020

Actual Primary Completion Date :

May 13, 2021

Actual Study Completion Date :

Jun 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EUS guided biliary drainage	Procedure: EUS guided biliary drainage A curvilinear endoscope is inserted orally and advanced to the duodenal bulb. Biliary accessibility will then be confirmed via endoscopic ultrasound (EE) from the duodenal bulb and via Doppler ultrasound to exclude any disturbing vessels. In order to maintain the stability of the duodenal bulb, the long endoscope position will be used whenever possible. A SMAL (AxiosTM) will be inserted with the assistance of cautery and then deployed. The use of a guidewire and the choice of stent size will be at the endoscopist's discretion.
Active Comparator: ERCP (Endoscopic Retrograde Cholangiopancreatography	Procedure: ERCP A duodenoscope is advanced to the papilla orally. The bile duct is then cannulated with a sphincterotome using the guidewire assisted technique. A cholangiogram is then performed followed by the placement of a self-expanding metallic bile stent. The performance of the biliary sphincterotomy before placement of the stent and the choice of the size of the stent will be at the discretion of the endoscopist.

Arm

Intervention/Treatment

Experimental: EUS guided biliary drainage

Procedure: EUS guided biliary drainage

A curvilinear endoscope is inserted orally and advanced to the duodenal bulb. Biliary accessibility will then be confirmed via endoscopic ultrasound (EE) from the duodenal bulb and via Doppler ultrasound to exclude any disturbing vessels. In order to maintain the stability of the duodenal bulb, the long endoscope position will be used whenever possible. A SMAL (AxiosTM) will be inserted with the assistance of cautery and then deployed. The use of a guidewire and the choice of stent size will be at the endoscopist's discretion.

Active Comparator: ERCP (Endoscopic Retrograde Cholangiopancreatography

Procedure: ERCP

A duodenoscope is advanced to the papilla orally. The bile duct is then cannulated with a sphincterotome using the guidewire assisted technique. A cholangiogram is then performed followed by the placement of a self-expanding metallic bile stent. The performance of the biliary sphincterotomy before placement of the stent and the choice of the size of the stent will be at the discretion of the endoscopist.

Outcome Measures

Primary Outcome Measures

Number of participant with stent dysfunction (obstruction or migration) requiring endoscopic, radiological or surgical intervention [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Privé des Peupliers	Paris		France	75013

Sponsors and Collaborators

Ramsay Générale de Santé
European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramsay Générale de Santé

ClinicalTrials.gov Identifier:

NCT05122858

Other Study ID Numbers:

2020-A00654-35

First Posted:

Nov 17, 2021

Last Update Posted:

Nov 17, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 17, 2021