The Safety and Feasibility of TachoSil® application on connections of the esophagus.

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10065961Term: Esophageal anastomotic leakSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Anastomotic leakage; MedDRA version: 14.1Level: LLTClassification code 10065890Term: Oesophageal anastomotic leakSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2011-005749-10-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-05
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis
• Ages 18-80
• Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

• Emergency resections of esophagus of stomach
• History of hypersensitivity reactions to human fibrinogen, human thrombin, or collagen.
• Patients having difficulty understanding the Dutch and English language
• Mentally incapable patients
• Pregnancy or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the feasibility of Tachosil application on esophageal anastomoses.;Secondary Objective: Evaluation of the safety of Tachosil application on esophageal anastomoses.;Primary end point(s): The primary efficacy parameter is the feasibility of TachoSil® application on esophageal anastomoses, which is assessed by 2 investigators who will evaluate video recordings. Feasibility is measured by the adherence and location of the TachoSil® patch, defined according to the following criteria:<br>•Adherence of complete TachoSil® patch<br>•TachoSil® covers at least 1 cm beyond the margins of anastomotic line<br>•Overlap of at least 1 cm if multiple patches are used;Timepoint(s) of evaluation of this end point: Duration of construction of the anastomosis, during surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety<br>•Mortality <br>-30-day (n)<br>-60-day (n)<br>-in hospital (n)<br>•Serious adverse events (n)<br>•Adverse events (n)<br>•Anastomotic leakage (n)<br>•Location of anastomotic leakage<br>-Cervical (n)<br>-Intrathoracic (n)<br>•Anastomotic stricture (n)<br>•Post-operative complications (n): Respiratory complications (pneumonia, ARDS, respiratory insufficiency), cardiac complications (ischemic and arrhythmic), lymphorrhea, vocal-cord paralysis, sepsis, urinary tract infection, wound infection, fistula, mediastinitis, thorax empyema.<br>•Postoperative course:<br>-Duration of Intensive Care stay (days)<br>-Duration of Medium Care stay (days)<br>-Total duration of hospital stay (days)<br>-Mechanical ventilation (days)<br>;Timepoint(s) of evaluation of this end point: Day of Surgery (day 0)<br>Day of discharge from surgical ward<br>3 months after surgery<br>9 months after surgery<br><br>