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Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma. (PLACE020)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529266
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Yang Hong, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastroesophageal Junction Cancer Anastomotic Leak Biological: Porcine Fibrin Sealant (PFS) Procedure: Surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage After Esophagectomy for Esophageal or Junctional Carcinoma: A Phase II,Single Arm,Prospective Study.
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : March 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A(Surgery+PFS)
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)
2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.
Other Name: Bioseal®

Procedure: Surgery
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.
Other Name: Esophagectomy




Primary Outcome Measures :
  1. Incidence of postoperative cervical anastomotic leakage [ Time Frame: within the first 3 months after esophagectomy ]
    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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: At end of trial- up to 2 years in follow up ]
    Overall survival (OS) is defined as the time period from the date of enrollment to the date of death or the last follow up

  2. Disease Free Survival [ Time Frame: At end of trial- up to 2 years in follow up ]
    Disease-free survival (DFS) is defined as the time period from the date of R0 resection to the date of disease recurrence or death.

  3. Postoperative Complications [ Time Frame: within the first 3 months after esophagectomy ]
    Postoperative complications will be recorded after each esophagectomy



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. More than 6 months of expected survival
  3. Age ranges from 18 to 80 years
  4. 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.
  5. WHO performance status (PS) of 0-1
  6. Informed consent will be obtained before the study

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529266


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Hong Yang, Ph.D., M.D. Sun Yat-sen University
Publications of Results:

Other Publications:
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Responsible Party: Yang Hong, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03529266    
Other Study ID Numbers: B2018-017-01
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anastomotic Leak
Postoperative Complications
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants