Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

Recruiting now

Conditions studied: Endoscopic Vacuum Therapy, Anastomotic Leak, Esophageal Perforation, Esophageal Perforation, Traumatic, EsoSponge, VACStent

In brief

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.

Key facts

Study ID

NCT05606822

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

200

Starts

2021-10-01

Expected to finish

2030-10-01

Last updated by the study team

2024-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Treated with EVT for anastomotic leakage after esophago-gastric surgery
• Signed informed consent form
• 18 years or older

You may not qualify if…

• No signed informed consent

Where it is running

• Amsterdam University Medical Centers, location VUmc — Amsterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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