Elective endoscopic gallbladder treatment (EEGBT) may represent a minimally invasive alternative to cholecystectomy in fragile elderly patients with benign gallbladder disease who are considered at high surgical risk (HSR). Evidence in this specific setting remains scarce and largely retrospective. We conducted a multicenter prospective study to evaluate safety and long-term clinical efficacy of EEGBT using lumen-apposing metal stents (LAMSs) in a large cohort of elderly HSR patients.

Prospective, multicentre study over a 4-year period, involving elderly (≥70 yrs) HSR patients (ASA score ≥ 3) with benign gallbladder disease in whom indication to cholecystectectomy was made. Patients first underwent EUS-guided gallbladder drainage using LAMSs, which worked as a port of entry for intracholecystic procedure(s) when needed. Primary endpoint was safety, defined by rate of intraprocedural, early (<14 days), or late (>14 days) adverse events (AEs) graded according AGREE classification. Secondary endpoints included: (i) long-term clinical success, defined as the absence of biliary recurrence within 24 months, in patients achieving either a full 2-years follow-up or ≥ 1 year of follow-up before death; (ii) predictors of biliary recurrence and mortality calculated by univariate and multivariate analysis.

A total of 95 consecutive frail elderly patients (mean age 83.9±7.2 years; 80% ASA III) with benign gallbladder disease deemed at high surgical risk for cholecystectomy underwent EEGBT. A transduodenal approach was performed in 55.8% of procedures, and a 10×10 mm LAMS was used in 82.1% of cases. Technical success was achieved in 94/95 patients (98.9%). Median procedural time was 10 minutes (IQR 8–16), and median hospital stay was 5 days (IQR 3–8.25). Intracolecystic lithotripsy (mechanical or holmium laser) was performed after EEGBT in 10/95 patients (10.5%), without any adverse events.

Overall, EEGBT-related adverse events occurred in 21/95 patients (22.1%). Among these, 5 patients experienced intraprocedural AEs only, 12 experienced late AEs only, and 4 patients (4.2%) developed both an intraprocedural and a delayed AE. Severe AEs—defined as those requiring surgery or resulting in death—were observed in 2/95 patients (2.1%). Intraprocedural AEs occurred in 5.3% of cases (4 minor bleedings and one stent misdeployment), all successfully managed endoscopically or conservatively. Late AEs occurred in 20/95 patients (21.05%). Among these, biliary recurrences were documented in 12 patients (12.6%), including 10 recurrent cholecystitis and 2 choledocholithiasis (one presenting with acute pancreatitis). Most late AEs were managed with conservative or endoscopic therapy. Other delayed AEs included 5 cases of minor bleeding and 3 buried-LAMS events, one of which required cholecystectomy.

During a median follow-up of 27 months (IQR 24–37), we observed an overall mortality of 18.9%, with one procedure-related death (1.2%). Fifteen patients were lost to follow-up or died before completing 12 months. Among 80 patients eligible for secondary endopoints, clinical success was achieved in 68 (85%). At univariate analysis, the transgastric approach showed a borderline association with increased biliary recurrence compared with the transduodenal route (p=0.050). At multivariate analysis, LAMS removal followed by placement of a double-pigtail plastic stent was independently associated with biliary recurrence compared with leaving the LAMS indwelling (p=0.028). Age was the only independent predictor of all-cause mortality (p=0.020).

In fragile elderly HSR patients with benign gallbladder disease, EEGBT provides very high technical success and favourable procedural safety. Long-term clinical success was high, and most late adverse events were manageable endoscopically or conservatively. LAMS removal emerged as the main driver of biliary recurrence, suggesting that long-term stent strategy is clinically relevant. With the aging of the population, this approach opens the possibility to treat electively an increasing number of elderly fragile patients with vulnerability and decreased physiological reserve, preventing or impairing post-procedural recovering and the return to preexisting functional level.