Fibrin Sealant in Esophageal Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03251040

Acronym

SEAL

Enrollment

Registered

2017-08-16

Start date

2015-08-01

Completion date

2017-05-01

Last updated

2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak

Keywords

Esophagogastric anastomosis, Fibrin sealant, Sealing

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.

Interventions

DEVICEAutologous activated fibrin sealant

Application of fibrin sealant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Pilot study

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Anastomotic leakage	30-day morbidity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026