Elective endoscopic gallbladder treatment for benign diseases in patients at high surgical risk and an indication to perform cholecystectomy: a prospective multicenter study

Aims EUS-guided gallbladder drainage (EUS-GBD) is the procedure of choice to treat patients with acute cholecystitis (AC) at high surgical risk.), We have recently shown in a retrospective multicenter study that elective endoscopic gallbladder treatment (EEGBT) is safe and effective in patients with benign gallbladder diseases at high surgical risk. We aimed to prospectively assess safety and efficacy of EEGBT in a large cohort of patients with benign gallbladder diseases at high surgical risk and an indication to perform cholecystectomy.

Methods We prospectively enrolled consecutive patients with benign gallbladder disease in whom an indication to perform cholecystectomy had been made who underwent EEGBT in nine tertiary care centers between April 2022 and November 2023. EEGBT consist first of lumen apposing metal stent (LAMS) placement, followed by gallstone lithotripsy when needed. Primary outcomes were technical and clinical success rate, and adverse events (AEs) rate. Secondary outcomes included recurrent biliary events, defined as the occurrence of biliary colic, cholangitis, choledocolithiasis or acute biliary pancreatitis during follow-up.

Results Overall, 50 patients were enrolled in the study period. Mean age was 82+9 years, male/female ratio 31/19, with an ASA score of III (33/50, 66%) or IV (17/50, 34%). The most frequent indication to perform EEGBT was mild recurrent acute cholecystitis (34/50, 68%), followed by biliary colic (9/50, 18%), acute biliary pancreatitis (6/50, 12%) and previous cholangitis (1/50, 2%). EUS-guided LAMS implantation was achieved more frequently from the duodenum (27/50, 54%), and the Hot-Axios was the preferred utilized stent (48/50, 96%). As for stent size, 10x10mm, 15x10mm, 16x20mm, 8x8 mm and 6x8 mm were placed in 52%, 38%, 4%, 4% and 2% of cases, respectively. Coaxial double pig-tails plastic stent (DPPS) placement at the end of the procedure was done in 24% (12/50) of cases. Technical and clinical success were achieved in 94% and 94% of patients, respectively. Intra-procedural AEs occurred in 3/50 (6%), (two distal flange LAMS misdeployments and one duodenal perforation contralateral to where the stent was placed). Post-procedural AEs occurred in 4/50 (8%) of cases (one buried LAMS after 2 months which required surgery, and 3 acute cholecystitis due to stent obstruction). Recurrent biliary events were 3 choledocolithiasis (6%). Mean follow up was 6±3 months. Overall, there were no EEGBT-related deaths.

Conclusions This study represents the first multicenter prospective study on EEGBT in patients with benign gallbladder disease at high surgical risk and an indication to perform cholecystectomy and strongly suggest this treatment to be safe and clinically effective. With the aging of the population, the number of patients with multiple comorbidities and gallstones that will require treatment will exponentially increase and EEGBT will play an important role in those at high surgical risk.

Publication History

Article published online:
15 April 2024