Clinical trial NCT02105506: Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses
Official title: Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Disease
Gastric Disease
Keywords: Esophagus
Stomach
Resection
Esophageal disease requiring surgery
Gastric disease requiring surgery
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Feasibility
timeFrame: Surgical procedure
Secondary outcomes:
measure: all cause mortality
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References: