Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.

NACompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

July 1, 2018

Primary Completion Date

December 27, 2019

Study Completion Date

July 27, 2020

Conditions
Acute Cholecystitis
Interventions
PROCEDURE

EUS-guided gallbladder drainage

During ERCP evaluation a self-expandable metallic stent will be deployed in the common biliary duct of the patients enrolled in both arms of the present study. A prophylaxis gallbladder drainage will be done using a 3.8 mm working-channel linear-array therapeutic echoendoscope (EG3870UTK;Pentax, Hamburg, Germany) attached to an ultrasound console (Avius Hitachi, Tokyo, Japan) within a transgastric and/or transduodenal approaches to the gallbladder puncture followed by placement of a lumen apposing stent (LAMS) (AXIOS; Xlumena Inc, CA, USA) with a 10 mm luminal diameter and a dumbbell-shaped flanges to bring together the 2 walls in apposition. These feature of the Axios decrease the risk for bile leak, stent migration, and stent occlusion.

PROCEDURE

Non EUS-guided gallbladder drainage

During ERCP evaluation a self-expandable metallic stent will be deployed in the common biliary duct of the patients enrolled in both arms of the present study. If the patient had an acute cholecystitis will be sent to surgery and be considered as a Non EUS-guided gallbladder drainage

Trial Locations (1)

090505

Instituto Ecuatoriano de Enfermedades Digestivas, Guayaquil

All Listed Sponsors
lead

Instituto Ecuatoriano de Enfermedades Digestivas

OTHER

NCT03729882 - Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement. | Biotech Hunter | Biotech Hunter