Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage (PLACE030)

NCT03847857 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: B2019-011-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 6

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 Anastomotic Leak

Keywords

Esophageal Cancer; Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cervical anastomotic leakage

  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 Overall survival (OS)

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

• Disease Free Survival Disease-free survival (DFS)

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

• Postoperative Complications

  within the first 3 months after esophagectomy

Study Arms (2)

Surgery+PFS

EXPERIMENTAL

Arm A consists of the concurrent application of Porcine Fibrin Sealant (PFS) on the gastroesophageal anastomosis during McKeown esophagectomy.

Biological: Porcine Fibrin Sealant (PFS); Procedure: McKeown esophagectomy

Surgery

PLACEBO COMPARATOR

Arm B underwent conventional anastomosis during McKeown esophagectomy.

Procedure: McKeown esophagectomy

Interventions

Porcine Fibrin Sealant (PFS) BIOLOGICAL

McKeown esophagectomy will be performed for patients with resectable thoracic esophageal carcinoma or gastroesophageal junction cancer. At last, 2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.

Also known as: Bioseal®

Surgery+PFS

McKeown esophagectomy 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.

Surgery; Surgery+PFS

Eligibility Criteria

• Age: 18 Years - 75 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 to75 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 (6)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Jieyang Affiliated Hospital, Sun Yat-sen University

Jieyang, Guangdong, 522000, China

Location

Cancer Hospital of Shantou University Medical College, Shantou

Shantou, Guangdong, :515000, China

Location

Zhongshan Peoples Hospital

Zhongshan, Guangdong, 528403, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

Related Publications (18)

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• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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 BACKGROUND

• 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.

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• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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 BACKGROUND

• 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.

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• 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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• 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

MeSH Terms

Conditions

Esophageal Neoplasms; Anastomotic Leak

Interventions

Bioseal

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

Study Officials

• Hong Yang, Ph.D.,M.D.

  Sun Yat-sen University Cancer Cente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A(Surgery+PFS) Arm A consists of the concurrent application of Porcine Fibrin Sealant (PFS) on the gastroesophageal anastomosis during Mckeown surgery . Biological/Vaccine: Porcine Fibrin Sealant (PFS) 2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line. B(Surgery)Arm B for conventional anastomosis

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 20, 2019
• Study Start: February 21, 2019
• Primary Completion: July 1, 2023
• Study Completion: December 31, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)