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ACTIVE NOT RECRUITING
NCT03847857
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

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.

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