Status:
ACTIVE_NOT_RECRUITING
Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage (PLACE030)
Lead Sponsor:
Sun Yat-sen University
Conditions:
Esophageal Anastomotic Leak
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 resectabl...
Detailed Description
Esophageal cancer (EC) is the most common cancers in the world, with more than 16,910 new cases and 15,690 deaths annually worldwide. Every year in China, no matter new cases or deaths account for mor...
Eligibility Criteria
Inclusion
- 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
- More than 6 months of expected survival
- Age ranges from 18 to75 years
- 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.
- WHO performance status (PS) of 0-1
- Informed consent will be obtained before the study
Exclusion
- Patients who have undergone definitive chemoradiotherapy
- Patients with concomitant hemorrhagic disease
- Patients with other uncontrollable status that cannot tolerate surgery
- Patients with known hypersensitivity to the porcine fibrin sealant product
- Pregnant or breast feeding
- Patients cannot signed the informed consent document because of psychological quality, family and social factors
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more
- Have a history of diabetes over 10 years and with poorly controlled blood sugar level
- Patients with serious cardiac, respiratory, hepatic, renal,hematologic, immunological disease or cachexy, who cannot tolerate surgery
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03847857
Start Date
February 21 2019
End Date
December 31 2025
Last Update
June 12 2025
Active Locations (6)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Jieyang Affiliated Hospital, Sun Yat-sen University
Jieyang, Guangdong, China, 522000
3
Cancer Hospital of Shantou University Medical College, Shantou
Shantou, Guangdong, China, :515000
4
Zhongshan Peoples Hospital
Zhongshan, Guangdong, China, 528403