Introduction
Managing leaks and defects of the upper gastrointestinal (UGI) tract remains challenging. Endoscopic Vacuum Therapy (EVT) is a promising option1-3; However, data on its efficacy in large cohorts remain limited.
Aims & Methods
This retrospective study with prospectively collected data enrolled all consecutive patients with UGI defects treated by EVT at a single academic center (San Raffaele Hospital, Milan, Italy) from March 2015 to September 2024. The primary outcome was clinical success (CS). Secondary outcomes included median treatment duration/devices, technical success (TS) and adverse events (AEs). Clinical success (CS) was defined as complete endoscopic and/or radiologic defect healing, with the patient remaining asymptomatic. Adverse events (AEs) were classified according to the AGREE classification.
Results
Over a period of 114 months, 96 patients [72.9% male, median age 67 years (IQR 57-75), 49% ASA 3] were included. Among them, 66 patients (68.7%) had anastomotic leaks after Ivor-Lewis esophagectomy, with 57% undergoing neoadjuvant chemotherapy. The median leak size was 7 mm (IQR 4-10), with a median circumferential involvement of 20% (IQR 10-40). A fistula involving the airways was present in 28.1% of cases. EVT was the first-line treatment in 78.1% of patients, with a median time from surgery to EVT of 7 days (IQR 4-9).
The overall clinical success (CS) rate was 72.9% (70/96 patients). Of the remaining patients, 20 underwent redo-surgery. Technical success for all procedures was 100% (302/302 procedures). The median treatment duration was 11 days (IQR 5-18), with a median of 3 EVT sessions (IQR 2-4). Three adverse events (AEs) (3/302, 1%) were recorded, including one bleeding episode and two sponge dislodgments, all managed endoscopically (AGREE IIIa). During a median follow-up of 62 days (IQR 33-155), two cases (2.1%) of esophageal strictures were reported (Table 1)
In the subgroup analysis, the intraluminal (IL) group (n=70) had a lower mean number of EVT sessions (3±2 vs. 5±3, p<0.001) and a shorter mean treatment duration (11±10 vs. 21±16 days, p<0.001) compared to the intracavitary (IC) group (n=26).
Table 1: Outcomes
| Patients n=96 | Median (IQR) OR n (%) |
| Clinical success, n | 70 (72.9%) |
| Technical success, n | 302/302 (100.0%) |
| Adverse events, n | 3/302 (1%) |
| Treatment duration (days) | 11 (5-18) |
| Number of EVT sessions | 3 (2-4) |
| Hospital stay (days) | 28 (17-43) |
| ICU admission, n | 14 (14.9%) |
| Stricture, n | 2 (2.1%) |
| Follow-up (days) | 62 (33-155) |
Conclusion
EVT is a safe and effective treatment for UGI defects. The IL approach was associated with shorter treatment duration and fewer sessions compared to the IC approach. Further controlled studies are needed to optimize EVT application and outcomes.
References
1. Mandarino FV, Barchi A, Leone L, et al. Endoscopic vacuum therapy versus self-expandable metal stent for treatment of anastomotic leaks < 30 mm following oncologic Ivor-Lewis esophagectomy: a matched case-control study. Surg Endosc. 2023;37(9):7039-7050. doi:10.1007/s00464-023-10213-8
2. Mandarino FV, Barchi A, D'Amico F, et al. Endoscopic Vacuum Therapy (EVT) versus Self-Expandable Metal Stent (SEMS) for Anastomotic Leaks after Upper Gastrointestinal Surgery: Systematic Review and Meta-Analysis. Life (Basel). 2023;13(2):287. Published 2023 Jan 19. doi:10.3390/life13020287
3. Mandarino FV, Barchi A, Fanti L, et al. Endoscopic vacuum therapy for post-esophagectomy anastomotic dehiscence as rescue treatment: a single center case series. Esophagus. 2022;19(3):417-425. doi:10.1007/s10388-022-00912-x