Lin Yao-Bin, Fu Jian-Hua, Huang Yan, Hu Yi-Huai, Luo Kong-Jia, Wang Ke-Xi, Bella Amos Éla, Situ Dong-Rong, Chen Ji-Yang, Lin Ting, D'Journo Xavier B, Novoa Nuria M, Brunelli Alessandro, Fernando Hiran C, Cerfolio Robert J, Ismail Mahmoud, Yang Hong
Department of Thoracic Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Esophageal Cancer Institute, Sun Yat-sen University Cancer Center, Guangzhou 510060, Guangdong Province, China.
Department of Thoracic Surgery, Avicenne Hospital, Bobigny 93000, France.
World J Gastrointest Oncol. 2020 Jun 15;12(6):651-662. doi: 10.4251/wjgo.v12.i6.651.
Esophagectomy is a pivotal curative modality for localized esophageal or esophagogastric junction cancer (EC or EJC). Postoperative anastomotic leakage (AL) remains problematic. The use of fibrin sealant (FS) may improve the strength of esophageal anastomosis and reduce the incidence of AL.
To assess the efficacy and safety of applying FS to prevent AL in patients with EC or EJC.
In this single-arm, phase II trial (Clinicaltrial.gov identifier: NCT03529266), 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 a circular stapled anastomosis. After performing the anastomosis, 2.5 mL of porcine FS was applied circumferentially. The primary endpoint was the proportion of patients with AL within 3 mo.
From June 4, 2018, to December 29, 2018, 57 patients were enrolled. At the data cutoff date (June 30, 2019), three (5.3%) of the 57 patients had developed AL, including two (3.5%) with esophagogastric AL and one (1.8%) 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 resume oral feeding after operation was 8 d (Interquartile range: 7.0-9.0 d). No adverse events related to FS were recorded. No deaths occurred within 90 d after surgery.
Perioperative sealing with porcine FS appears safe and may prevent AL after esophagectomy in patients with resectable EC or EJC. Further phase III studies are warranted.
食管切除术是局限性食管癌或食管胃交界癌（EC或EJC）的关键治愈性治疗方式。术后吻合口漏（AL）仍然是个问题。使用纤维蛋白密封剂（FS）可能会提高食管吻合的强度并降低AL的发生率。
评估应用FS预防EC或EJC患者发生AL的疗效和安全性。
在这项单臂II期试验（Clinicaltrial.gov标识符：NCT0352926）中，我们招募了年龄在18至80岁之间、临床分期为T1-4aN0-3M0的可切除EC或EJC患者。采用开放式或微创McKeown食管切除术并进行圆形吻合器吻合。吻合完成后，在吻合口周围环形应用2.5 mL猪源FS。主要终点是3个月内发生AL的患者比例。
从2018年6月4日至2018年12月29日共纳入57例患者。在数据截止日期（2019年6月30日），57例患者中有3例（5.3%）发生了AL，其中2例（3.5%）为食管胃AL，1例（1.8%）为胃瘘。吻合口狭窄和其他主要术后并发症的发生率分别为1.8%和17.5%。术后恢复经口进食所需的中位时间为8天（四分位间距：7.0-9.0天）。未记录到与FS相关的不良事件。术后90天内无死亡病例。
围手术期使用猪源FS似乎是安全的，并且可能预防可切除EC或EJC患者食管切除术后的AL。有必要进行进一步的III期研究。
