Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma.

Summary

The primary objective is to evaluate the efficacy and assess the role of Porcine Fibrin Sealant (Bioseal®) in preventing cervical anastomotic leakage after esophagectomy in the patients with resectable thoracic esophageal cancer and gastroesophageal junction cancer.

Timeline

Start

2018-06-01

Primary completion

2019-03-31

Completion

2021-08-22

Publications

• Background Saldana-Cortes JA, Larios-Arceo F, Prieto-Diaz-Chavez E, De Buen EP, Gonzalez-Mercado S, Alvarez-Villasenor AS, Prieto-Aldape MR, Fuentes-Orozco C, Gonzalez-Ojeda A. Role of fibrin glue in the prevention of cervical leakage and strictures after esophageal reconstruction of caustic injury. World J Surg. 2009 May;33(5):986-93. doi: 10.1007/s00268-009-9949-x.
• Results Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
• Results Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
• Results Jones CE, Watson TJ. Anastomotic Leakage Following Esophagectomy. Thorac Surg Clin. 2015 Nov;25(4):449-59. doi: 10.1016/j.thorsurg.2015.07.004. Epub 2015 Sep 8.
• Results Low DE. Diagnosis and management of anastomotic leaks after esophagectomy. J Gastrointest Surg. 2011 Aug;15(8):1319-22. doi: 10.1007/s11605-011-1511-0. Epub 2011 May 10.
• Results Zhou C, Ma G, Li X, Li J, Yan Y, Liu P, He J, Ren Y. Is minimally invasive esophagectomy effective for preventing anastomotic leakages after esophagectomy for cancer? A systematic review and meta-analysis. World J Surg Oncol. 2015 Sep 4;13:269. doi: 10.1186/s12957-015-0661-z.
• Results Law S, Fok M, Chu KM, Wong J. Comparison of hand-sewn and stapled esophagogastric anastomosis after esophageal resection for cancer: a prospective randomized controlled trial. Ann Surg. 1997 Aug;226(2):169-73. doi: 10.1097/00000658-199708000-00008.
• Results Yuan Y, Zeng X, Hu Y, Xie T, Zhao Y. Omentoplasty for oesophagogastrostomy after oesophagectomy. Cochrane Database Syst Rev. 2014 Oct 2;2014(10):CD008446. doi: 10.1002/14651858.CD008446.pub3.
• Results Takeuchi H, Miyata H, Gotoh M, Kitagawa Y, Baba H, Kimura W, Tomita N, Nakagoe T, Shimada M, Sugihara K, Mori M. A risk model for esophagectomy using data of 5354 patients included in a Japanese nationwide web-based database. Ann Surg. 2014 Aug;260(2):259-66. doi: 10.1097/SLA.0000000000000644.
• Results van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
• Results Liu Q, Chen J, Wen J, Yang H, Hu Y, Luo K, Tan Z, Fu J. Comparison of right- and left-approach esophagectomy for elderly patients with operable thoracic esophageal squamous cell carcinoma: a propensity matched study. J Thorac Dis. 2017 Jul;9(7):1883-1890. doi: 10.21037/jtd.2017.06.22.
• Results Rutegard M, Lagergren P, Rouvelas I, Lagergren J. Intrathoracic anastomotic leakage and mortality after esophageal cancer resection: a population-based study. Ann Surg Oncol. 2012 Jan;19(1):99-103. doi: 10.1245/s10434-011-1926-6. Epub 2011 Jul 19.
• Results Ederle A, Scattolini C, Bulighin G, Benini L, Orlandi PG, Talamini G, Vantini I. Does the combination of a human fibrin sealant with ranitidine accelerate the healing of duodenal ulcer? Ital J Gastroenterol. 1991 Jul-Aug;23(6):354-6.
• Results Hirst NA, Tiernan JP, Millner PA, Jayne DG. Systematic review of methods to predict and detect anastomotic leakage in colorectal surgery. Colorectal Dis. 2014 Feb;16(2):95-109. doi: 10.1111/codi.12411.
• Results Nguyen NT, Nguyen CT, Stevens CM, Steward E, Paya M. The efficacy of fibrin sealant in prevention of anastomotic leak after laparoscopic gastric bypass. J Surg Res. 2004 Dec;122(2):218-24. doi: 10.1016/j.jss.2004.05.005.
• Results Martin I, Au K. Does fibrin glue sealant decrease the rate of anastomotic leak after a pancreaticoduodenectomy? Results of a prospective randomized trial. HPB (Oxford). 2013 Aug;15(8):561-6. doi: 10.1111/hpb.12018. Epub 2012 Dec 27.
• Results Tekinbas C, Erol MM, Akdogan R, Turkyilmaz S, Aslan M. Treatment of anastomotic leaks after esophagectomy with endoscopic hemoclips. J Thorac Cardiovasc Surg. 2009 Mar;137(3):766-7. doi: 10.1016/j.jtcvs.2008.01.052. Epub 2008 Sep 14. No abstract available.
• Results Lee S, Ahn JY, Jung HY, Lee JH, Choi KS, Kim DH, Choi KD, Song HJ, Lee GH, Kim JH, Kim BS, Yook JH, Oh ST, Kim BS, Han S. Clinical outcomes of endoscopic and surgical management for postoperative upper gastrointestinal leakage. Surg Endosc. 2013 Nov;27(11):4232-40. doi: 10.1007/s00464-013-3028-y. Epub 2013 Jun 20.
• Results Upadhyaya VD, Gopal SC, Gangopadhyaya AN, Gupta DK, Sharma S, Upadyaya A, Kumar V, Pandey A. Role of fibrin glue as a sealant to esophageal anastomosis in cases of congenital esophageal atresia with tracheoesophageal fistula. World J Surg. 2007 Dec;31(12):2412-5. doi: 10.1007/s00268-007-9244-7.

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