Anastomotic LeakSEALNCT03251040
Fibrin Sealant in Esophageal Surgery
A study testing Autologous activated fibrin sealant in people with Anastomotic Leak, run by Amsterdam UMC, location VUmc.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anastomotic Leak
- What is being tested?
- Autologous activated fibrin sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other malignancies
- Previous esophageal surgery were excluded
About this study
Official title: Autologous Activated Fibrin Sealant for the Esophageal Anastomosis, a Feasibility Study
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.
- Conditions
- Anastomotic Leak
- Being tested
- Autologous activated fibrin sealant
- Keywords
- Esophagogastric anastomosis, Fibrin sealant, Sealing
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous activated fibrin sealantDevice
Application of fibrin sealant
| Study group | Role | What they receive |
|---|---|---|
| Fibrin sealant | Other | Single arm pilot study Receives: Device: Autologous activated fibrin sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
Measured: 30-day morbidity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Aug 2015
- Primary completion1 Apr 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Plat, Amsterdam UMC, location VUmc
- Investigators
- Freek Daams, MD PhD, Study director, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251040
- Sponsor's protocol ID
- 2015.458
- Acronym
- SEAL
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30527497
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Activated Fibrin Sealant for the Esophageal Anastomosis, a Feasibility Study
- ClinicalTrials.gov ID
- NCT03251040
- Acronym / sponsor ID
- SEAL / 2015.458
- Conditions
- Anastomotic Leak
- Keywords
- Esophagogastric anastomosis, Fibrin sealant, Sealing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Fibrin sealant | Other | Device: Autologous activated fibrin sealantSingle arm pilot study |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Other malignancies
- Previous esophageal surgery were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous activated fibrin sealantApplication of fibrin sealant | Device | Fibrin sealant |
Primary outcome
Anastomotic leakage
Time frame: 30-day morbidity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 30527497Plat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freek Daams, MD PhD study director
Amsterdam UMC, location VUmc
Questions about this trial
What is this clinical trial studying?
A study testing Autologous activated fibrin sealant in people with Anastomotic Leak, run by Amsterdam UMC, location VUmc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage (time frame: 30-day morbidity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.