Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

NCT02105506 | Completed DMC

• 1 other identifier: NL38212
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Esophagus; Stomach; Resection; Esophageal disease requiring surgery; Gastric disease requiring surgery

Outcome Measures

Primary Outcomes (1)

• Feasibility

  The adherence of the Tachosil patch

  Surgical procedure

Secondary Outcomes (1)

• all cause mortality

  within the first 30 days (plus or minus 3 days) after surgery

Study Arms (1)

Tachosil patch

EXPERIMENTAL

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

Interventions

Tachosil patch DRUG

Tachosil patch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• R. van Hillegersberg: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Esophageal Diseases; Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. R. van Hillegersberg, surgeon

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

NL (1)