Actively Recruiting

Age: 18Years +
All Genders
ID05606822

Endoscopic Vacuum Therapy for Anastomotic Leakage After Upper Gastrointestinal Surgery and Esophageal Perforation: A Multicenter Retrospective Cohort Study

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-07-23

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand the best uses and methods of endoscopic vacuum therapy (EVT) for treating transmural defects in the upper gastrointestinal (GI) tract. These defects include anastomotic leakage after surgery, Boerhaave syndrome, iatrogenic perforations, and other injuries that affect the full thickness of the esophageal or gastric wall. Because these defects can cause serious complications like leakage of stomach contents and inflammation leading to sepsis, timely and effective treatment is critical. EVT has emerged as a promising endoscopic treatment, but questions remain about when and how to use it best. The study collects data retrospectively and prospectively on patients treated with EVT for these upper GI tract defects without administering any new treatments, as this is an observational study. It will assess different EVT techniques such as EsoSponge and VACStent, various vacuum pressures, and whether the therapy is applied inside the lumen or into cavities. The research focuses on patients who have already received EVT for anastomotic leakage after esophago-gastric surgery or esophageal perforations from different causes. Participants provide informed consent to allow collection of their medical data. Researchers will evaluate outcomes like the success rate of EVT over 1 to 3 years, mortality within 6 months, adverse events, number and duration of treatment cycles. The study helps identify which patients and defect types respond best to EVT and which techniques are most effective. The total study duration extends to October 2030, with no intervention changes required from participants during the observation period.

CONDITIONS

Brief Title

Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Treated with endoscopic vacuum therapy for anastomotic leakage after esophago-gastric surgery
  • Signed informed consent form
  • 18 years or older
Not Eligible

You will not qualify if you...

  • No signed informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Monitoring

Duration - Up to 3 years

Participants who undergo routine care are observed for treatment outcomes and adverse events related to endoscopic vacuum therapy.

Follow-up visits as part of routine healthcare over the observation period

Trial Site Locations

Total: 1 location

1

Amsterdam University Medical Centers, location VUmc

Amsterdam, Netherlands

Actively Recruiting

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Research Team

R

Roos Pouw, MD, PhD

L

Lisanne Pattynama, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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