Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

Conditions
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Esophageal Disease, Gastric Disease

Intervention / Treatment
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* Drug: Tachosil patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis Male and female gender Ages 18-80 Signed informed consent For females of childbearing potential: Patient uses a reliable contraceptive method: contraceptive pill, intrauterine device, subdermal implantation, or transdermal patch Patient has a negative serum or urine pregnancy test. Exclusion Criteria: Emergency resections of esophagus of stomach Unsigned informed consent History of hypersensitivity reactions to human fibrinogen, human thrombin, or collagen. Patients having difficulty understanding Dutch and English Mentally incapable patients Pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tachosil patch<br>Tachosil patch (9.5 x 4.8 cm), containing human fibrinogen (5.5 mg/cm2) and human thrombin (2.0 IU/cm2), applied during surgery. Up to 7 patches per participant may be applied. | Drug: Tachosil patch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | The adherence of the Tachosil patch | Surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | within the first 30 days (plus or minus 3 days) after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagus, Stomach, Resection, Esophageal disease requiring surgery, Gastric disease requiring surgery