Autologous Activated Fibrin Sealant for the Esophageal Anastomosis, a Feasibility Study

Amsterdam UMC, location VUmc0 sites15 target enrollmentAugust 1, 2015

ConditionsAnastomotic Leak

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anastomotic Leak
Sponsor: Amsterdam UMC, location VUmc
Enrollment: 15
Primary Endpoint: Anastomotic leakage
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. The investigators aimed to investigate feasibility of additional sealing by means of autologous fibrin sealant of the esophageal anastomosis.

Registry

clinicaltrials.gov

Start Date

August 1, 2015

End Date

May 1, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amsterdam UMC, location VUmc

Responsible Party

Principal Investigator

Victor Plat

Principal investigator

Amsterdam UMC, location VUmc

Eligibility Criteria

Inclusion Criteria

•Aged 18 - 90 years
•Scheduled to undergo elective minimal invasive esophageal surgery with thoracic or cervical anastomosis (i.e. Ivor Lewis, Orringer or McKeown esophagectomy).
•physical status (American Society of Anesthesiologists) of 3 or lower