Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    Collection of data from electronic health record

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Anastomotic leakage after gastrointestinal surgery1 intervention
Group B: Esophageal perforation (Boerhaave syndrome, iatrogenic, trauma, other)1 intervention

Trial outcomes

Primary outcomes

1

Success rate

Successful treatment of EVT for the upper GI defect: closure confirmed via endoscopy

Time frame
1-3 years

Secondary outcomes

1

Mortality

30-day and in-hospital mortality, relation to EVT

Time frame
6 months (due to possible prolonged hospital stay)
2

Adverse events

(Severe) adverse events related to EVT

Time frame
6 months
3

Treatment cycles

Including number of EVT-related endoscopies, number of used sponges/VACStents

Time frame
6 months
4

Duration of treatment

Including duration of treatment in days, hospital stay in days, ICU stay in days

Time frame
6 months

Other outcomes

Sponsors and contacts

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