Introduction
In the treatment of esophageal carcinoma, abdomino-thoracic esophagectomy is the curative therapeutic option, often combined with perioperative (radio-)chemotherapy. This procedure is associated with high complication rates and significant mortality. Anastomotic leakage, with a pooled incidence of 11% (ranging from 0% to 49%)1, constitutes a major postoperative complication. New therapeutic options, such as the EndoVac (Stent) system, offer promising approaches for its management. The aim of this study was to identify risk factors for the occurrence of anastomotic leaks and to evaluate the effectiveness of various treatment methods.
Aims & Methods
We present data from 2022–2024 collected at the University Medical Center Göttingen, a high-volume center for esophageal surgery. A total of 242 patients who underwent abdomino-thoracic esophagectomy, either as primary treatment or after neoadjuvant therapy, were included. Structured data collection and analysis were carried out using Excel and GraphPad Prism.
Results
In this patient cohort, 79.3% were male (n=192) and 20.7% female (n=50), with a mean age of 65.4 years and a mean BMI of 26.1 kg/m² at the time of surgery. The most common pre-existing conditions were 56.6% arterial hypertension (n=137), 7,9% COPD (n=19), 21% diabetes mellitus (n=51), as well as coronary artery disease (CAD) and peripheral arterial disease (PAD), each 8.2% (n=20). Histologically, 80.1% (n=194) adenocarcinomas and 19.4% (n=47) squamous cell carcinomas. 88.8% of patients received neoadjuvant therapy (n=215): 35.5% radiochemotherapy (n=86) and 53% chemotherapy (n=129). Of all patients, 24.8% (n=60) underwent primary open surgery and 75,3% (n=182) had minimally invasive hybrid procedures. By 2024, minimally invasive approaches had increased to 83.3% (n=86).
Anastomotic leakage occurred in 25 patients (10.3%), with clinical manifestation appearing on average 8 days postoperatively (range: 1–29 days). An association with the occurrence of anastomotic leakage was observed for nicotine abuse (OR 1.35; 95% CI: 0.60–3.11), alcohol consumption (OR 1.69; 95% CI: 0.66–4.24), coronary artery disease (CAD), and peripheral arterial disease (PAD) (each OR 2.37; 95% CI: 0.80–7.81); however, none reached statistical significance in Fisher’s exact test (all p > 0.05). Complete remission (24.4%, n=59) was significantly associated with an increased risk of leakage (OR 3.51; 95% CI: 1.53–7.86; p = 0.005).
All 25 anastomotic leaks were initially treated with EndoVac, healing successfully in 21 cases (96%). Four patients (16%) required revision surgery. An EndoVacStent was implanted in 52% of cases (n=13), with 20% receiving only an EndoVacStent (n=5) and 32% treated with a combination of sponge and stent (n=8). The average duration of EndoVac therapy was 15 days (range: 1–42 days), with the system being exchanged three times on average. In-hospital mortality was 1.6% (n=4).
Conclusion
In summary, the EndoVac and EndoVacStent systems have proven to be safe and effective treatment options for anastomotic leakage. Patients with complete remission showed an increased susceptibility to anastomotic leakage. Our data supports the importance of studies like ESORES (DRKS00022050)2 and PRESTO (NCT05713838)3, investigating non-operative treatment approaches for clinical complete remission cases followed by a watch-and-wait strategy.
References
1. Sivesh K Kamarajah, Aaron Lin, Thahesh Tharmaraja, Yashvi Bharwada, James R Bundred, Dmitri Nepogodiev, Richard P T Evans, Pritam Singh, Ewen A Griffiths, Risk factors and outcomes associated with anastomotic leaks following esophagectomy: a systematic review and meta-analysis, Diseases of the Esophagus, Volume 33, Issue 3, March 2020, doz089, https://doi.org/10.1093/dote/doz089
2. ESORES – A prospective registry study for patients with esophageal cancer and clinical complete response after neoadjuvant therapy. German Clinical Trials Register (DRKS00022050). https://www.drks.de/DRKS00022050
3. PRESTO – Prospective evaluation of watch-and-wait strategies in complete responders to neoadjuvant therapy for esophageal cancer. ClinicalTrials.gov (NCT05713838).
https://clinicaltrials.gov/ct2/show/NCT05713838
