NCT03251040

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

August 7, 2017

Last Update Submit

August 18, 2017

Conditions

Anastomotic Leak

Keywords

Esophagogastric anastomosisFibrin sealantSealing

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leakage

    30-day morbidity

Study Arms (1)

Fibrin sealant

OTHER

Single arm pilot study

Device: Autologous activated fibrin sealant

Interventions

Autologous activated fibrin sealantDEVICE

Application of fibrin sealant

Fibrin sealant

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Other malignancies
  • Previous esophageal surgery were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30527497DERIVED

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Freek Daams, MD PhD

    Amsterdam UMC, location VUmc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 16, 2017

Study Start

August 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share