Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

NCT ID: NCT02105506

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-12-31

Brief 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.

Conditions

Esophageal Disease; Gastric Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tachosil patch

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.

Group Type: EXPERIMENTAL

Tachosil patch

Intervention Type: DRUG

Interventions

Tachosil patch

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

R. van Hillegersberg

OTHER

Sponsor Role: lead

Responsible Party

R. van Hillegersberg

Prof. R. van Hillegersberg, surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Countries

Netherlands

Other Identifiers

NL38212

Identifier Type: -

Identifier Source: org_study_id