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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

February 21, 2019

Primary Completion Date

July 1, 2023

Study Completion Date

December 31, 2025

Conditions
Esophageal Anastomotic Leak
Interventions
BIOLOGICAL

Porcine Fibrin Sealant (PFS)

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.

PROCEDURE

McKeown esophagectomy

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.

Trial Locations (6)

510060

Sun Yat-sen University Cancer Center, Guangzhou

522000

Jieyang Affiliated Hospital, Sun Yat-sen University, Jieyang

528403

Zhongshan Peoples Hospital, Zhongshan

:515000

Cancer Hospital of Shantou University Medical College, Shantou, Shantou

Unknown

Sichuan Cancer Hospital, Chengdu

Shanghai Chest Hospital, Shanghai

All Listed Sponsors
lead

Sun Yat-sen University

OTHER