Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 20, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
High-risk Patients With Acute Calculous Cholecystitis (ACC)
Interventions
PROCEDURE

Transmural ultrasound-guided gallbladder drainage

TUGD will be performed using the bi-flanged LAMSs mounted on an electrocautery-enhanced delivery system (Hot-AXIOS™) by an experienced endoscopist defined as \> 10 LAMS positioning per year. The diameter and length of the stent and the modality of placing the stent (under complete EUS view or with endoscopic or fluoroscopic guidance) will be chosen at the discretion of the endoscopist performing the procedure

PROCEDURE

Laparoscopic cholecystectomy

LC will be performed by the four-trocar technique with transection of the cystic duct and cystic artery after reaching the critical view of safety. ELC will be performed by a surgeon trained and experienced in laparoscopic surgery defined as \> 5 laparoscopic procedures for ACC on a yearly basis

Trial Locations (1)

27100

RECRUITING

SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo, Pavia

All Listed Sponsors
lead

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER