Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junc… (NCT03529266) | Clinical Trial Compass
CompletedPhase 2
Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma.
China57 participantsStarted 2018-06-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 to 80 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 criteria
✕. 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
What they're measuring
1
Incidence of postoperative cervical anastomotic leakage
Timeframe: within the first 3 months after esophagectomy