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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
R. van Hillegersberg, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT02105506
First received: April 2, 2014
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention
Esophageal Disease
Gastric Disease
Drug: Tachosil patch

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Feasibility [ Time Frame: Surgical procedure ] [ Designated as safety issue: No ]
    The adherence of the Tachosil patch


Secondary Outcome Measures:
  • all cause mortality [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
n/a

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105506

Contacts
Contact: Leonie Haverkamp, MD +31887555555 ext 1731 L.Haverkamp@umcutrecht.nl
Contact: Richard van Hillegersberg, MD PhD +31887558074 R.vanHillegersberg@umcutrecht.nl

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Leonie Haverkamp, MD    +31887555555 ext 1731    L.Haverkamp@umcutrecht.nl   
Principal Investigator: Richard van Hillegersberg, MD, PhD         
Sub-Investigator: Jelle P Ruurda, MD, PhD         
Sub-Investigator: Leonie Haverkamp, MD         
Sponsors and Collaborators
R. van Hillegersberg
  More Information

No publications provided

Responsible Party: R. van Hillegersberg, Prof. R. van Hillegersberg, surgeon, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02105506     History of Changes
Other Study ID Numbers: NL38212
Study First Received: April 2, 2014
Last Updated: April 4, 2014
Health Authority: The Netherlands: IRB (METC University Medical Centre Utrecht)
The Netherlands: CCMO

Keywords provided by 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

ClinicalTrials.gov processed this record on October 01, 2014