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

NCT03529266 | Completed Phase 2 DMC

• 1 other identifier: B2018-017-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer; Gastroesophageal Junction Cancer; Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cervical anastomotic leakage

  Cervical anastomotic leakage will be diagnosed based on a combination of clinical presentation, radiological findings, and/or endoscopic findings within the first 3 months after the operation.

  within the first 3 months after esophagectomy

Secondary Outcomes (3)

• Overall survival

  At end of trial- up to 2 years in follow up

• Disease Free Survival

  At end of trial- up to 2 years in follow up

• Postoperative Complications

  within the first 3 months after esophagectomy

Study Arms (1)

A(Surgery+PFS)

EXPERIMENTAL

Arm A consists of the concurrent application of Porcine Fibrin Sealant (PFS) on the gastroesophageal or coloesophageal anastomosis during Mckeown surgery .

Biological: Porcine Fibrin Sealant (PFS); Procedure: Surgery

Interventions

Porcine Fibrin Sealant (PFS) BIOLOGICAL

2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.

Also known as: Bioseal®

A(Surgery+PFS)

Surgery PROCEDURE

McKeown esophagectomy including open or minimally invasive esophagectomy will be performed for patients with resectable thoracic esophageal carcinoma or gastroesophageal junction cancer. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery. At last, 2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.

Also known as: Esophagectomy

A(Surgery+PFS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of squamous cell carcinoma or adenocarcinoma of thoracic esophageal carcinoma or gastroesophageal junction cancer with Stage T1-4aN0-3M0, according to 8th edition of Union for International Cancer Control (UICC) staging system
• More than 6 months of expected survival
• Age ranges from 18 to 80 years
• Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
• WHO performance status (PS) of 0-1
• Informed consent will be obtained before the study

You may not qualify if:

• Patients who have undergone definitive chemoradiotherapy
• Patients with concomitant hemorrhagic disease
• Patients with other uncontrollable status that cannot tolerate surgery
• Patients with known hypersensitivity to the porcine fibrin sealant product
• Pregnant or breast feeding
• Patients cannot signed the informed consent document because of psychological quality, family and social factors
• Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more
• Have a history of diabetes over 10 years and with poorly controlled blood sugar level
• Patients with serious cardiac, respiratory, hepatic, renal,hematologic, immunological disease or cachexy, who cannot tolerate surgery

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (19)

• 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.

  PMID: 19234736 BACKGROUND

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  PMID: 26808342 RESULT

• 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.

  PMID: 26515945 RESULT

• 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.

  PMID: 21557015 RESULT

• 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.

  PMID: 26338060 RESULT

• 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.

  PMID: 9296510 RESULT

• 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.

  PMID: 25274134 RESULT

• 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.

  PMID: 24743609 RESULT

• 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.

  PMID: 22646630 RESULT

• 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.

  PMID: 28839986 RESULT

• 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.

  PMID: 21769467 RESULT

• 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.

  PMID: 1742526 RESULT

• 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.

  PMID: 23992097 RESULT

• 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.

  PMID: 15555621 RESULT

• 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.

  PMID: 23458447 RESULT

• 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.

  PMID: 19258111 RESULT

• 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.

  PMID: 23783553 RESULT

• 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.

  PMID: 17917772 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Anastomotic Leak

Interventions

Bioseal; Surgical Procedures, Operative; Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures

Study Officials

• Hong Yang, Ph.D., M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 18, 2018
• Study Start: June 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: August 22, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)