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)

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 13, 2020

Primary Completion Date

May 13, 2021

Study Completion Date

June 14, 2021

Conditions
Endoscopic Retrograde CholangiopancreatographyBiliary DrainageEchography Ultrasound
Interventions
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.

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.

Trial Locations (1)

75013

Hôpital Privé des Peupliers, Paris

All Listed Sponsors
collaborator

European Clinical Trial Experts Network

OTHER

lead

Ramsay Générale de Santé

OTHER

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) | Biotech Hunter | Biotech Hunter