Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R. van Hillegersberg

Criteria

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