Fibrin Sealant in Esophageal Surgery

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.

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Key information

Conditions

Anastomotic Leak Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous activated fibrin sealant

Device

Application of fibrin sealant

Primary outcomes

Anastomotic leakage

Time frame: 30-day morbidity

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Acronym: SEAL

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Aug 16, 2017
Registry last updated: Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed