Gastrointestinal (GI) tract leaks and fistulae—whether spontaneous or resulting from postoperative leakage or dehiscence—pose substantial clinical challenges and carry significant morbidity and mortality. Endoscopic vacuum therapy (EVT) and hybrid EVT-Self-expanding metal stent (SEMS) technology have emerged as promising minimally invasive therapeutic options as alternative to surgery. This multicenter prospective study evaluates the effectiveness and safety of EVT and hybrid EVT-SEMS in the management of GI tract leaks and fistulae

A total of 32 patients were prospectively included, of which 27 received EVT by Esosponge^®/Endosponge^®(Boston Scientific, Marlborough, Massachusetts, USA) and 5 received hybrid EVT-SEMS by VacStent GIä(Micro-Tech Europe GmbH, Düsseldorf, Germany) from 2022 onward across 2 portuguese centers. Demographic data, clinical characteristics, and treatment outcomes were collected. The primary endpoint was successful closure of the leak or fistula, confirmed through both endoscopic and radiologic assessment. Secondary outcomes included the need for adjuvant endoscopic therapy, and complication, readmission, and mortality rates.

Median follow-up was 100 weeks (IQR 56) and 82.1% of the patients included were male (n=22), with a median age of 67 years (IQR 12). Most sponges were placed in the upper GI tract (n=19) for malignant aetiology (75.8% of cases). Three patients received sponge in the lower GI tract due to surgery for pelvic/perianal abscess (n=2) and prostatic cancer (n=1). Both endoluminal and intracavitary sponges were used, with the former (median 4 [1-37]) being more frequently used than the latter (median 1 [0-11]). Main aetiology for VacStent placement was Boerhaave syndrome (n=4) and surgery for esophageal adenocarcinoma (n=1). One every three patients (30.3%) presented with sepsis at admission and median timing until device placement was 11.5 days (IQR 17.2). Median mural defect size was 15 mm (IQR 15) and median hospitalization length was 55 days (IQR 50.7). EVT by sponge/VacStent therapy achieved a high overall closure rate of 84.2% (100% for VacStent alone, p=0.342). Although a median of 4.5 treatment sessions was required, the need for additional non-EVT endoscopic interventions remained low (5.3%). Technique-related complications were uncommon (5.3%) and included migration and late stenosis, and readmission rates were low (13.5%). Mortality was low and not directly associated with device use. After multivariate logistic regression, sponge at upper GI tract was significantly associated with endoscopic success (OR 0.019, CI95% 0.001-0.531, p=0.020), but sepsis at admission proved to be an important factor, although without statistical significance (OR 0.09, CI95% 0.06-1.315, p=0.078).

This multicenter prospective study demonstrates that EVT and hybrid EVT-SEMS are highly effective and safe modalities for treating spontaneous and postoperative GI tract leaks/fistulae. With strong closure rates, minimal complications, and favorable overall outcomes, these vacuum-based therapies represent valuable endoscopic strategies and support their expanding role in managing of complex GI leaks/fistulae.