NCT03847857Active, not recruitingPhase 3
Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage (PLACE030)
A Multicenter Prospective Randomized Controlled Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma. (PLACE030)
Source: ClinicalTrials.gov · Last updated 12 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (actual)
- First submitted
- 19 Feb 2019
- Start date
- 21 Feb 2019
- Primary completion date
- 1 Jul 2023
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03847857
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 360
- From 21 Feb 2019 to the primary completion date, 1 Jul 2023
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concomitant hemorrhagic disease
- Patients with other uncontrollable status that cannot tolerate surgery
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more
Other illness
- Patients with known hypersensitivity to the porcine fibrin sealant product
- 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
Other
- Patients who have undergone definitive chemoradiotherapy
- Pregnant or breast feeding
- Patients cannot signed the informed consent document because of psychological quality, family and social factors
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Jieyang Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Jieyang | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Cancer Hospital of Shantou University Medical College, Shantou Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
| Zhongshan Peoples Hospital Coordinator of this site? Confirm its status | Zhongshan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.