Using endoscopic vacuum therapy for treating defects in the upper gastrointestinal tract
Official title: Endoscopic Vacuum Therapy for Anastomotic Leakage After Upper Gastrointestinal Surgery / Endoscopic Vacuum Therapy for Esophageal Perforation: A Multicenter Retrospective Cohort Study
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT05606822 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | October 1, 2021 |
| Main results expected | October 1, 2030 |
| Study ends | October 1, 2030 |
| Registry record updated | July 23, 2024 |
| Trial ID | NCT05606822 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have undergone EVT for anastomotic leakage following esophago-gastric surgery.
✕Probably not a fit
Patients who do not provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using fingertip CRP point-of-care tests to spot leaks after elective colorectal surgery
This project will see if daily fingertip CRP point-of-care tests can detect anastomotic leaks early in people having elective colorectal surgery.
-
Gastric preconditioning before esophagectomy for patients at high risk of anastomotic leak
This registry will see if gastric preconditioning by percutaneous angioembolization before esophagectomy changes how often anastomotic leaks happen in people with esophageal cancer who are at high risk.
-
Signia circular stapler for left-sided colon, sigmoid, and rectal resections
This study will try the Signia circular stapler with Tri-Staple technology to see if it safely creates bowel reconnections in adults having left-sided colon, sigmoid, or rectal surgery.
-
Pre-emptive endoscopic vacuum therapy to reduce anastomotic leaks after colorectal cancer surgery
This will try using pre-emptive endoscopic vacuum therapy after colorectal cancer surgery to see if it lowers early anastomotic leaks in adults having radical colorectal operations.
-
Causes and outcomes of anastomotic leaks after colorectal surgery
This project will try to identify which pre-, intra-, and post-operative factors predict anastomotic leakage and build a prediction model for adults having colorectal resection with bowel reconnection.
-
Leakage risk after ileo-colic sutures using MonoPlus® following right hemicolectomy
This will try MonoPlus® suture material for ileo-colic anastomosis in adults having elective right hemicolectomy for colon cancer to see if the 30-day leakage rate is not higher than published rates.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.