Anastomotic leakage has been reported in up to 30% of patients  who have esophagectomy or gastrectomy, with an associated morbidity and mortality rate of 20%–50% [1]. Treatment options for upper gastrointestinal (UGI) leaks include endoscopic, surgical, and conservative therapy [2]. Endoluminal vacuum therapy (EVT) uses the principles of vacuum-assisted closure of external wounds to improve and accelerate healing by removing infected secretions, reducing edema, increasing local perfusion, and promoting granulation tissue formation [3]. Most studies of EVT for UGI leaks and perforations have been retrospective case series or case reports to date. We conducted a meta-analysis of the efficacy and safety of EVT to treat UGI defects in adults.

An expert librarian conducted searches of the MEDLINE full file (via Ovid) and Embase databases to identify studies of Eso-SPONGE™ (Boston Scientific Corporation, Massachusetts, USA) published in English January 1, 2008‒May 30, 2025. Clinical studies (including meta-analyses & systematic reviews) and case reports/series including more than 10 patients were included. Efficacy and safety outcomes were assessed using a random-effects meta-analysis to estimate the proportion of patients with the outcome. Efficacy outcomes were UGI EVT technical success, clinical success, and reinterventions. The safety outcome was the proportion of patients with ≥1 serious adverse event (SAE).

Data from 301 patients who participated in 8 observational studies were included in the analysis of all eligible publications. The estimated pooled proportions of patients with technical success and clinical success were 100% (95% CI 99.7–100%) and 77.4% (95% CI 65.2%‒87.6%), respectively. Patients had reinterventions associated with closure management (15.3%, 95% CI 8.4%‒23.8%) or adverse events (8.2%, 95% CI 1.2%, 20.7%). The estimated pooled proportion of patients with ≥1 SAE during the study period was 21.3% (95% CI 6.6%‒41.5%), with a mortality rate of 5.9% (95% CI 3.5%‒8.9%). Among 127 patients with an anastomotic leak from 5 studies with available data, 7 (5.5%) patients died from one of the following causes: acute respiratory distress syndrome with or without multiorgan failure (2), sepsis (4), pneumonia (1). Among 10 patients with a perforation in a single study, no deaths were reported.

EVT using Eso-SPONGE for UGI anastomotic leaks and perforations showed high technical success and good clinical success. High rates of adverse events and mortality occurred in ill patient populations at high baseline risk of complications. (Funded by Boston Scientific Corporation)