Endoluminal vacuum therapy using a new “fistula sponge” in treating defects of the upper gastrointestinal tract – a comparative, retrospective cohort study.

Abstract Background: Anastomotic insufficiencies (AI) and perforations of the upper gastrointestinal tract (uGIT) result in high morbidity and mortality. As treatment options surgical revision, endoscopic stent placement as well as endoluminal vacuum therapy (EVT) have been established. The Eso-Sponge® is the only licensed EVT system with limitations in treating small defects (Methods: The aim of the study was to compare indications, technical/clinical success rates, and complications in a retrospective, comparative study of both EVT approaches. Between 01/2018 and 01/2021 clinical data of patients undergoing FS-EVT or conventional EVT (cEVT; Eso-Sponge®, Braun Melsungen, Germany) due to AI/perforation of the uGIT were recorded. Indication, diameter of leakage, therapeutic success, and complications during the procedure were assessed. FSs were prepared using a nasogastric tube and a porous drainage film (Suprasorb® CNP, Lohmann 52 cEVT). FS-EVT was performed in 60% suffering from AI (cEVT = 68%) and 40% from perforation (cEVT = 32%; p > 0.05). FS-EVT's duration was significantly shorter than cEVT (7.6±12.0d vs. 15.1±14.3d; p = 0.014). The mean diameter of the defect was 9 mm in the FS-EVT group compared to 24 mm in cEVT (p 0.05). Conclusions: EVT comprises an efficient treatment option for transmural defects of the uGIT. In daily clinical practice, fistulas <10 mm with large abscess formations poses a special challenge since intraluminal cEVT usually is ineffective. In these cases, the concept of extraluminal FS placement is safe and effective.