Cholecystectomy vs EUS-guided GBD With Stone Removal

NARecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

October 25, 2023

Primary Completion Date

October 2, 2024

Study Completion Date

November 2, 2024

Conditions
Cholelithiasis
Interventions
PROCEDURE

LAMS placement for cholecystostomy

The EUS-guided cholecystostomy entails placing a 10 mm x 10 mm or 10mm x 15mm Electrocautery-Enhanced LAMS for direct cholecystoscopy with a transnasal gastroscope. Then, the cholecystostomy will be performed with an echoendoscope, assisted by fluoroscopy to allow the puncturing of the gallbladder form either the duodenal bulb (cholecysto-duodenoscopy) or the gastric antrum (cholecysto-gastrostomy). Subsequently, from the most optimal anatomic point it will be tutored with a 10mmx10mm or 10mm x 15mm LAMS to create anastomosis between the structures. Then, the stone clearance will be performed by endoscopy (basket catheters) or by cholangioscopy (mechanical lithotripsy with or without basket catheters).

PROCEDURE

Laparoscopic cholecystectomy

A laparoscopic biliary exploration along with an elective laparoscopic cholecystectomy will be performed by experienced laparoscopic surgeons (over 100 laparoscopic procedures yearly) by three or four-trocar technique with transection of the cystic duct and artery.

Trial Locations (1)

090505

RECRUITING

Instituto Ecuatoriano de Enfermedades Digestivas, Guayaquil

All Listed Sponsors
lead

Instituto Ecuatoriano de Enfermedades Digestivas

OTHER