Gastric Disease Clinical Trial
Official title:
Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses
Rationale: The construction of esophageal anastomoses is associated with considerable risk
at postoperative anastomotic leakage. Application of TachoSil®, a tissue sealant with human
fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially
prevent anastomotic leakage.
Objective: Evaluation of feasibility and safety of TachoSil® application on esophageal
anastomoses.
Study design: Non-randomized, non-blinded, single-center intervention study. Study
population: Patients, 18-80 years old, undergoing an elective total gastrectomy with an
esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be
enrolled. A total number of 15 patients will be included in the study.
Intervention: Gastric or esophageal resection will be executed according to the common
procedures used in the UMC Utrecht. After construction of the esophageal anastomosis, all
enrolled participants will receive a TachoSil® patch, which will be applied on the
esophageal anastomosis intra-operatively. Hence, TachoSil® is used as an add-on therapy.
TachoSil® will be degraded enzymatically in a period of approximately 24 weeks after
application.
Main study parameters/endpoints: The primary endpoint is feasibility, which is assessed by
evaluation of adherence of the patch. A time-action analysis of the application of the
Tachosil patch will be performed.
Nature and extent of the burden associated with participation: The burden for the patient is
minimal. The total surgical procedure will be prolonged with 10-15 minutes. Postoperative
care and outpatient visits do not differ from regular protocol. TachoSil® is approved and
registered for supportive treatment in surgery for improvement of haemostasis and to promote
tissue sealing by the European Commission.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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