Clinical trial · Interventional
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)
NCT03847857CI-TRIAL-00090925active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Anastomotic Leak | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| McKeown esophagectomy | Procedure | — | UNRESOLVED |
| Porcine Fibrin Sealant (PFS) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery+PFS
- description
- Arm A consists of the concurrent application of Porcine Fibrin Sealant (PFS) on the gastroesophageal anastomosis during McKeown esophagectomy.
- interventionNames
- Biological: Porcine Fibrin Sealant (PFS)
- Procedure: McKeown esophagectomy
- type
- PLACEBO_COMPARATOR
- label
- Surgery
- description
- Arm B underwent conventional anastomosis during McKeown esophagectomy.
- interventionNames
- Procedure: McKeown esophagectomy
Primary outcomes (1)
- measure
- Incidence of postoperative cervical anastomotic leakage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. More than 6 months of expected survival 3. Age ranges from 18 to75 years 4. 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. 5. WHO performance status (PS) of 0-1 6. Informed consent will be obtained before the study Exclusion Criteria: 1. Patients who have undergone definitive chemoradiotherapy 2. Patients with concomitant hemorrhagic disease 3. Patients with other uncontrollable status that cannot tolerate surgery 4. Patients with known hypersensitivity to the porcine fibrin sealant product 5. Pregnant or breast feeding 6. Patients cannot signed the informed consent document because of psychological quality, family and social factors 7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more 8. Have a history of diabetes over 10 years and with poorly controlled blood sugar level 9. Patients with serious cardiac, respiratory, hepatic, renal,hematologic, immunological disease or cachexy, who cannot tolerate surgery
References
Publications (18)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. PMID 26742998
- BACKGROUNDChen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. PMID 26808342
- BACKGROUNDJones CE, Watson TJ. Anastomotic Leakage Following Esophagectomy. Thorac Surg Clin. 2015 Nov;25(4):449-59. doi: 10.1016/j.thorsurg.2015.07.004. Epub 2015 Sep 8. PMID 26515945
- BACKGROUNDLow DE. Diagnosis and management of anastomotic leaks after esophagectomy. J Gastrointest Surg. 2011 Aug;15(8):1319-22. doi: 10.1007/s11605-011-1511-0. Epub 2011 May 10. PMID 21557015
- BACKGROUNDZhou C, Ma G, Li X, Li J, Yan Y, Liu P, He J, Ren Y. Is minimally invasive esophagectomy effective for preventing anastomotic leakages after esophagectomy for cancer? A systematic review and meta-analysis. World J Surg Oncol. 2015 Sep 4;13:269. doi: 10.1186/s12957-015-0661-z. PMID 26338060
- BACKGROUNDLaw S, Fok M, Chu KM, Wong J. Comparison of hand-sewn and stapled esophagogastric anastomosis after esophageal resection for cancer: a prospective randomized controlled trial. Ann Surg. 1997 Aug;226(2):169-73. doi: 10.1097/00000658-199708000-00008. PMID 9296510
- BACKGROUNDYuan Y, Zeng X, Hu Y, Xie T, Zhao Y. Omentoplasty for oesophagogastrostomy after oesophagectomy. Cochrane Database Syst Rev. 2014 Oct 2;2014(10):CD008446. doi: 10.1002/14651858.CD008446.pub3. PMID 25274134
- BACKGROUNDTakeuchi H, Miyata H, Gotoh M, Kitagawa Y, Baba H, Kimura W, Tomita N, Nakagoe T, Shimada M, Sugihara K, Mori M. A risk model for esophagectomy using data of 5354 patients included in a Japanese nationwide web-based database. Ann Surg. 2014 Aug;260(2):259-66. doi: 10.1097/SLA.0000000000000644.