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Fibrin Sealant in Esophageal Surgery (SEAL)

Primary Purpose

Anastomotic Leak

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autologous activated fibrin sealant
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anastomotic Leak focused on measuring Esophagogastric anastomosis, Fibrin sealant, Sealing

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Fibrin sealant

    Arm Description

    Single arm pilot study

    Outcomes

    Primary Outcome Measures

    Anastomotic leakage

    Secondary Outcome Measures

    Full Information

    First Posted
    August 7, 2017
    Last Updated
    August 18, 2017
    Sponsor
    Amsterdam UMC, location VUmc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03251040
    Brief Title
    Fibrin Sealant in Esophageal Surgery
    Acronym
    SEAL
    Official Title
    Autologous Activated Fibrin Sealant for the Esophageal Anastomosis, a Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2015 (Actual)
    Primary Completion Date
    April 1, 2016 (Actual)
    Study Completion Date
    May 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Amsterdam UMC, location VUmc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anastomotic Leak
    Keywords
    Esophagogastric anastomosis, Fibrin sealant, Sealing

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pilot study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fibrin sealant
    Arm Type
    Other
    Arm Description
    Single arm pilot study
    Intervention Type
    Device
    Intervention Name(s)
    Autologous activated fibrin sealant
    Intervention Description
    Application of fibrin sealant
    Primary Outcome Measure Information:
    Title
    Anastomotic leakage
    Time Frame
    30-day morbidity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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 Exclusion Criteria: Other malignancies Previous esophageal surgery were excluded
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Freek Daams, MD PhD
    Organizational Affiliation
    Amsterdam UMC, location VUmc
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30527497
    Citation
    Plat VD, Bootsma BT, van der Wielen N, van der Peet DL, Daams F. Autologous Activated Fibrin Sealant for the Esophageal Anastomosis: A Feasibility Study. J Surg Res. 2019 Feb;234:49-53. doi: 10.1016/j.jss.2018.08.049. Epub 2018 Sep 27.
    Results Reference
    derived

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