Tisseel® as a Reinforcement of Esophagojejunal Anastomoses

Summary

Background: The dehiscence of esophagojejunal anastomoses is one of the most serious complications after total gastrectomy in patients with gastric cancer. Any method of avoiding this problem will affect not only the postoperative course but also the prognostic of disease. Methods: This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Group, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer. The rate of anastomosis leak will be measured with clinical, radiological and analytic parameters. Objective: Analyze the efficacy of Tisseel® as a reinforcement in reducing the rate of anastomotic esophagojejunal anastomoses.

Timeline

Start

2020-07-21

Primary completion

2021-07-01

Completion

2022-07-01

Publications

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• Background Yoo HM, Lee HH, Shim JH, Jeon HM, Park CH, Song KY. Negative impact of leakage on survival of patients undergoing curative resection for advanced gastric cancer. J Surg Oncol. 2011 Dec;104(7):734-40. doi: 10.1002/jso.22045. Epub 2011 Jul 25.
• Background Garcia-Granero A, Frasson M, Flor-Lorente B, Blanco F, Puga R, Carratala A, Garcia-Granero E. Procalcitonin and C-reactive protein as early predictors of anastomotic leak in colorectal surgery: a prospective observational study. Dis Colon Rectum. 2013 Apr;56(4):475-83. doi: 10.1097/DCR.0b013e31826ce825.
• Background Giaccaglia V, Salvi PF, Antonelli MS, Nigri G, Pirozzi F, Casagranda B, Giacca M, Corcione F, de Manzini N, Balducci G, Ramacciato G. Procalcitonin Reveals Early Dehiscence in Colorectal Surgery: The PREDICS Study. Ann Surg. 2016 May;263(5):967-72. doi: 10.1097/SLA.0000000000001365.
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• Background Reid-Lombardo KM, Farnell MB, Crippa S, Barnett M, Maupin G, Bassi C, Traverso LW; Pancreatic Anastomotic Leak Study Group. Pancreatic anastomotic leakage after pancreaticoduodenectomy in 1,507 patients: a report from the Pancreatic Anastomotic Leak Study Group. J Gastrointest Surg. 2007 Nov;11(11):1451-8; discussion 1459. doi: 10.1007/s11605-007-0270-4. Epub 2007 Aug 21.
• Background Perry Y, Towe CW, Kwong J, Ho VP, Linden PA. Serial Drain Amylase Can Accurately Detect Anastomotic Leak After Esophagectomy and May Facilitate Early Discharge. Ann Thorac Surg. 2015 Dec;100(6):2041-6; discussion 2046-7. doi: 10.1016/j.athoracsur.2015.05.092. Epub 2015 Aug 25.
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• Background Cools-Lartigue J, Andalib A, Abo-Alsaud A, Gowing S, Nguyen M, Mulder D, Ferri L. Routine contrast esophagram has minimal impact on the postoperative management of patients undergoing esophagectomy for esophageal cancer. Ann Surg Oncol. 2014 Aug;21(8):2573-9. doi: 10.1245/s10434-014-3654-1. Epub 2014 Mar 28.
• Background Struecker B, Chopra S, Heilmann AC, Spenke J, Denecke C, Sauer IM, Bahra M, Pratschke J, Andreou A, Biebl M. Routine Radiologic Contrast Agent Examination After Gastrectomy for Gastric Cancer Is Not Useful. J Gastrointest Surg. 2017 May;21(5):801-806. doi: 10.1007/s11605-017-3384-3. Epub 2017 Feb 15.
• Background Strauss C, Mal F, Perniceni T, Bouzar N, Lenoir S, Gayet B, Palau R. Computed tomography versus water-soluble contrast swallow in the detection of intrathoracic anastomotic leak complicating esophagogastrectomy (Ivor Lewis): a prospective study in 97 patients. Ann Surg. 2010 Apr;251(4):647-51. doi: 10.1097/SLA.0b013e3181c1aeb8.
• Background Jones CM, Clarke B, Heah R, Griffiths EA. Should routine assessment of anastomotic integrity be undertaken using radiological contrast swallow after oesophagectomy with intra-thoracic anastomosis? Best evidence topic (BET). Int J Surg. 2015 Aug;20:158-62. doi: 10.1016/j.ijsu.2015.06.076. Epub 2015 Jul 10.

Drugs

Indications