Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

Gastric Disease Clinical Trial

— SAFE-T  

Official title:

Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105506
• Other study ID #: NL38212
• Status: Completed
• Phase: N/A
• First received: April 2, 2014
• Last updated: April 23, 2015
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: IRB (METC University Medical Centre Utrecht)The Netherlands: CCMO
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Disease
• Esophageal Diseases
• Gastric Disease
• Stomach Diseases

Intervention

Drug:
• Tachosil patch

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
R. van Hillegersberg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	The adherence of the Tachosil patch	Surgical procedure	No
Secondary	all cause mortality		within the first 30 days (plus or minus 3 days) after surgery	Yes