Endoscopic ultrasound (EUS)–guided gallbladder drainage using lumen-apposing metal stents (LAMS) has become an important therapeutic option for the management of acute cholecystitis in patients who are not surgical candidates. The aim of our study was to assess the efficacy and safety of creating a cholecystoenteric anastomosis followed by elective stent removal, in order to prevent late adverse events such as stent migration or occlusion in this high-risk population.

This prospective study included all patients with biliary disease who had a contraindication to surgery and were managed with EUS-guided gallbladder drainage. The study began in September 2024 and is currently ongoing. Patients with biliary or pancreatic malignancies were excluded. The protocol consisted of two steps: placement of a 15-mm Axios® lumen-apposing metal stent, followed by stent removal two months later. After the second procedure, all patients underwent scheduled follow-up evaluations every three months.

A total of 40 patients were included in the study. The mean age was 88.1 years (range 73–99), with a mean Charlson comorbidity index of 5.85. Eighteen patients were receiving anticoagulant therapy, which was systematically discontinued 48 hours before the procedure. Fourteen patients had a history of cholecystitis, including one following percutaneous drainage. Thirty patients presented with acute cholecystitis, associated with pancreatitis in 7 cases and cholangitis in 20 cases. Additionally, 4 patients had isolated pancreatitis and 6 had isolated cholangitis. All patients received antibiotic therapy.

Six patients had a sclerotic–atrophic gallbladder and required intravesicular saline injection using a 19G needle (mean volume: 20 mL) to facilitate drainage. Twenty-two patients had common bile duct stones and underwent ERCP. The mean procedure time was 28.9 minutes (range 11–80). Technical success was achieved in 100% of cases, and clinical success in 97%. One patient, an 85-year-old with grade 3 cholecystitis, died during hospitalization. The mean length of stay was 5 days.

Among the included patients, 20 underwent a second procedure with outpatient stent removal (study ongoing; 11 patients still awaiting removal). Complete gallbladder clearance was obtained in 17 patients. Three patients had residual stones: two were removed using a Dormia basket, and one large stone required laser lithotripsy. At the time of stent removal, four patients had duodenal ulcers at the stent contact site, two had stent obstruction due to food debris, and one showed evidence of intravesicular stent migration.

The mean follow-up period was 4.5 months (range 1–12). Three deaths were recorded at 2, 3, and 6 months after the initial procedure, none related to biliary pathology. No long-term complications or recurrent biliary events were observed.

According to the preliminary results of our study, cholecystoenteric anastomosis should be considered the procedure of choice for patients at very high surgical risk, given its high technical and clinical success rates, effective gallbladder clearance, and ability to prevent long-term recurrence.