Using endoscopic vacuum therapy for treating defects in the upper gastrointestinal tract
Endoscopic Vacuum Therapy for Anastomotic Leakage After Upper Gastrointestinal Surgery / Endoscopic Vacuum Therapy for Esophageal Perforation: A Multicenter Retrospective Cohort Study
This study is testing if endoscopic vacuum therapy can effectively treat serious problems in the upper digestive tract, like leaks and perforations, to help improve patient care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05606822 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and best practices of endoscopic vacuum therapy (EVT) for patients with transmural defects in the upper gastrointestinal tract, such as anastomotic leaks and esophageal perforations. The study will collect both retrospective and prospective data to determine the success rates of EVT and identify optimal indications and techniques for its application. Participants will provide informed consent to allow for comprehensive data collection regarding their treatment outcomes and characteristics. The findings could help refine treatment protocols for these serious conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone EVT for anastomotic leakage following esophago-gastric surgery.
Not a fit: Patients who do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with upper GI tract defects, potentially reducing complications and improving recovery outcomes.
How similar studies have performed: While EVT is a relatively novel approach for treating upper GI tract defects, previous studies have shown promising results in similar contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam
- Amsterdam University Medical Centers, location VUmc — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Roos Pouw, MD, PhD — Amsterdam University Medical Center, location VU
- Study coordinator: Roos Pouw, MD, PhD
- Email: r.e.pouw@amsterdamumc.nl
- Phone: +3120 4444444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.