CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
Porcine Fibrin Sealant (PFS) +1 morebiological
Likely dose
Porcine Fibrin Sealant (PFS) 2.5mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03529266
NCT03529266Phase 2Completed
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Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage After Esophagectomy for Esophageal or Junctional Carcinoma: A Phase II,Single Arm，Prospective Study.

Sun Yat-sen University·interventional·Posted May 18, 2018·Updated Aug 24, 2021

In Brief

A Phase 2 clinical trial evaluating Porcine Fibrin Sealant (PFS) and Surgery for Esophageal Cancer and 2 related conditions. Completed, enrolled 57 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer, Gastroesophageal Junction Cancer, Anastomotic Leak
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 18, 2018
Enrollment StartJun 1, 2018
Primary CompletionMar 31, 2019
Study CompletionAug 22, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.1 years ago

Interventions

Porcine Fibrin Sealant (PFS)biological

2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.

Surgeryprocedure

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. At last, 2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.