Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma. (PLACE020)
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|ClinicalTrials.gov Identifier: NCT03529266|
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : March 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastroesophageal Junction Cancer Anastomotic Leak||Biological: Porcine Fibrin Sealant (PFS) Procedure: Surgery||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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®
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
- 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.
- 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
- 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.
- Postoperative Complications [ Time Frame: within the first 3 months after esophagectomy ]Postoperative complications will be recorded after each esophagectomy
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
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Hong Yang, Ph.D., M.D.||Sun Yat-sen University|