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Phase 2 Study Of Fibrin Sealant For Prevention Of Anastomotic Leakage In Esophageal Or Junctional Cancer
Yihuai Hu, Yaobin Lin, Yan Huang, Kongjia Luo, Jianhua Fu, Hong Yang
Sun Yat-sen University Cancer Center, Guangzhou, China
BACKGROUND: Surgery is the primary treatment for esophageal or esophagogastric junction cancer (EC or EJC), but anastomotic leakage (AL) remains problematic. The use of fibrin sealant (FS) may improve the strength of anastomosis and reduce incidence of AL. We aimed to assess the efficacy and safety of application of porcine FS in the prevention of AL for patients with EC or EJC. METHODS: In this single-arm, phase 2 study, we recruited patients aged 18-80 years with resectable EC or EJC, clinically staged as T1-4aN0-3M0. An open or minimally invasive McKeown esophagectomy was performed with circular stapled anastomosis. After anastomosis, 2.5 ml of porcine FS was applied circumferentially. The primary endpoint was the proportion of patients with AL within 3 months. RESULTS: From Jun 4, 2018, to Dec 29, 2018, 57 patients were enrolled, including 47 patients with thoracic EC and 5 with EJC. At data cutoff date (Jun 30, 2019), 2 (3.5%) of the 57 patients had developed cervical AL. One (1.8%) patient was diagnosed with gastric fistula. The incidence of anastomotic stricture and other major postoperative complications was 1.8% and 17.5%, respectively. The median time needed to initiate oral feeding after operation was 8 days (IQR 7.0-9.0). No adverse events related to FS were recorded. No deaths occurred within 90 days after surgery. CONCLUSIONS: Perioperative sealing with porcine FS is safe and shows promise for the prevention of AL after esophagectomy in patients with resectable EC or EJC. Further phase 3 study is warranted. ClinicalTrials.gov number: NCT03529266.
| Postoperative complications | No. (%), N=57 |
| Anastomotic leakage | 2 (4%) |
| Anastomotic stricture | 1 (2%) |
| Gastric fistula | 1 (2%) |
| Arrhythmia | 11 (19%) |
| Laryngeal nerve injury | 10 (18%) |
| Pneumonia | 8 (14%) |
| Heart failure | 6 (11%) |
| Respiratory failure | 4 (7%) |
| Acute respiratory distress syndrome | 3 (5%) |
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