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Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses (SAFE-T)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02105506
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Esophageal Disease Gastric Disease Drug: Tachosil patch

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses
Study Start Date : September 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: TachoSil
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Drug: Tachosil patch


Outcome Measures

Primary Outcome Measures :
  1. Feasibility [ Time Frame: Surgical procedure ]
    The adherence of the Tachosil patch


Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105506


Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
R. van Hillegersberg
More Information

Responsible Party: R. van Hillegersberg, Prof. R. van Hillegersberg, surgeon, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02105506     History of Changes
Other Study ID Numbers: NL38212
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by R. van Hillegersberg, UMC Utrecht:
Esophagus
Stomach
Resection
Esophageal disease requiring surgery
Gastric disease requiring surgery

Additional relevant MeSH terms:
Esophageal Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases