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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05606822
Other study ID # 2021.0457
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date October 1, 2023

Study information

Verified date October 2022
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Roos Pouw, MD, PhD
Phone +3120 4444444
Email r.e.pouw@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to learn about the best indications and techniques regarding endoscopic vacuum therapy (EVT) in patients with a transmural defect in the upper gastrointestinal (GI) tract (e.g. anastomotic leakage, Boerhaave syndrome, iatrogenic perforation, other). The main questions it aims to answer are: - What is the success rate of EVT for transmural defects in the upper GI tract? - What are the best indications for EVT in the upper GI tract? (e.g. etiology, patient characteristics, defect characteristics) - What are the best techniques for EVT in the upper GI tract? (e.g. EsoSponge, VACStent, vacuum pressure, intraluminal/intracavitary) Participants will be asked for informed consent to retrospectively and prospectively collect data on EVT.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Treated with EVT for anastomotic leakage after esophago-gastric surgery - Signed informed consent form - 18 years or older Exclusion Criteria: - No signed informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational
Collection of data from electronic health record

Locations

Country Name City State
Netherlands Amsterdam University Medical Centers, location VUmc Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate 1-3 years
Secondary Mortality 1-3 years
Secondary Adverse events 1-3 years
Secondary Treatment specifics Including number of EVT-related endoscopies, number of used sponges/VACStents 1-3 years
Secondary Treatment specifics Including days between exchanges, duration of treatment in days, hospital stay in days, ICU stay in days 1-3 years
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