Details

Autor(en) / Beteiligte

• 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
• Hong, Yang
• the AME Thoracic Surgery, Collaborative Group

Titel

Fibrin sealant for esophageal anastomosis: A phase II study

Ist Teil von

• World journal of gastrointestinal oncology, 2020-06, Vol.12 (6), p.651-662

Ort / Verlag

Baishideng Publishing Group Inc

Erscheinungsjahr

2020

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• BACKGROUNDEsophagectomy 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. AIMTo assess the efficacy and safety of applying FS to prevent AL in patients with EC or EJC. METHODSIn 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. RESULTSFrom 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. CONCLUSIONPerioperative 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.