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Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage (PLACE030)
Sponsor: Sun Yat-sen University
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.
Official title: A Multicenter Prospective Randomized Controlled Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma. (PLACE030)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2019-02-21
Completion Date
2025-12-31
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (6)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Jieyang Affiliated Hospital, Sun Yat-sen University
Jieyang, Guangdong, China
Cancer Hospital of Shantou University Medical College, Shantou
Shantou, Guangdong, China
Zhongshan Peoples Hospital
Zhongshan, Guangdong, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Shanghai Chest Hospital
Shanghai, China