Fibrin Sealant in Esophageal Surgery

Anastomotic Leak Clinical Trial

— SEAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251040
• Other study ID #: 2015.458
• Status: Completed
• Phase: N/A
• First received: August 7, 2017
• Last updated: August 18, 2017
• Start date: August 1, 2015
• Est. completion date: May 1, 2017

Study information

• Verified date: August 2017
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 1, 2017
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Exclusion Criteria:

• Other malignancies

• Previous esophageal surgery were excluded

Related Conditions & MeSH terms

• Anastomotic Leak

Intervention

Device:
• Autologous activated fibrin sealant
Application of fibrin sealant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leakage		30-day morbidity