Phase II trial evaluating esophageal anastomotic reinforcement with a biologic, degradable, extracellular matrix after total gastrectomy and esophagectomy Journal Article


Authors: Vos, E. L.; Nakauchi, M.; Capanu, M.; Park, B. J.; Coit, D. G.; Molena, D.; Yoon, S. S.; Jones, D. R.; Strong, V. E.
Article Title: Phase II trial evaluating esophageal anastomotic reinforcement with a biologic, degradable, extracellular matrix after total gastrectomy and esophagectomy
Abstract: BACKGROUND: A biologic, degradable extracellular matrix (ECM) has been shown to support esophageal tissue remodeling, which could reduce the risk of anastomotic leak following total gastrectomy and esophagectomy. We evaluated the safety and efficacy of reinforcing the anastomosis with ECM in reducing anastomotic leak as compared to a matched cohort. STUDY DESIGN: In this single-center, nonrandomized phase II trial, gastric or esophageal adenocarcinoma patients undergoing total gastrectomy or esophagectomy were recruited from November 2013 through December 2018. ECM was surgically wrapped circumferentially around the anastomosis. Anastomotic leak was assessed clinically and by contrast study and defined as clinically significant if requiring invasive treatment (grade 3 or higher). Anastomotic stenosis, other adverse events, symptoms, and dysphagia score were collected by standardized forms at regular follow-up visits at approximately postoperative days (POD) 21 and 90. Patients receiving ECM were compared to a cohort matched for surgery type and age. RESULTS: ECM placement was not feasible in 9 of 75 patients (12%), resulting in 66 patients receiving ECM. Total gastrectomy was performed in 50 patients (76%) and esophagectomy in 16 (24%). Clinically significant anastomotic leak was diagnosed in 6 of 66 patients (9.1%) (3/50 [6.0%] after gastrectomy, 3/16 [18.8%] after esophagectomy); this rate did not differ from that in the matched cohort (p = 0.57). Stenosis requiring invasive treatment occurred in 8 patients (12.5%), and 10 patients (15.6%) reported not being able to eat a normal diet at POD 90. No adverse events related to ECM were reported. CONCLUSIONS: Esophageal anastomotic reinforcement after total gastrectomy or esophagectomy with a biologic, degradable ECM was mostly feasible and safe, but was not associated with a statistically significant decrease in anastomotic leak. Copyright © 2022 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.
Journal Title: Journal of the American College of Surgeons
Volume: 234
Issue: 5
ISSN: 1072-7515
Publisher: Elsevier Science, Inc.  
Date Published: 2022-05-01
Start Page: 910
End Page: 917
Language: English
DOI: 10.1097/xcs.0000000000000113
PUBMED: 35426405
PROVIDER: scopus
PMCID: PMC9128801
DOI/URL:
Notes: Article -- Export Date: 2 May 2022 -- Source: Scopus
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MSK Authors
  1. Sam Yoon
    108 Yoon
  2. Marinela Capanu
    388 Capanu
  3. Bernard J Park
    265 Park
  4. Vivian Strong
    268 Strong
  5. Daniel Coit
    542 Coit
  6. David Randolph Jones
    418 Jones
  7. Daniela   Molena
    277 Molena
  8. Elvira Lise Vos
    26 Vos