About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Treated with EVT for anastomotic leakage after esophago-gastric surgery
Signed informed consent form
18 years or older
Disqualifiers
No signed informed consent
Trial population
Patients treated with EVT for a transmural defect in the upper GI tract, including anastomotic leakage, Boerhaave syndrome, iatrogenic perforations, trauma, etc.
Trial design
Cohort
Prospective
Treatments tested in this trial
Observational
Other interventionCollection of data from electronic health record
Treatment groups
Trial outcomes
Primary outcomes
Success rate
Successful treatment of EVT for the upper GI defect: closure confirmed via endoscopy
Secondary outcomes
Mortality
30-day and in-hospital mortality, relation to EVT
Adverse events
(Severe) adverse events related to EVT
Treatment cycles
Including number of EVT-related endoscopies, number of used sponges/VACStents
Duration of treatment
Including duration of treatment in days, hospital stay in days, ICU stay in days
Sponsors and contacts
Click on the lead sponsor to view all of their trials.