Removing Barrett's esophagus with neoplasia using endoscopic techniques
Complete Resection of Barrett's Esophagus Harboring Neoplasia With Endoscopic Submucosal Dissection.
This study is testing a new endoscopic technique to safely remove abnormal growths in patients with Barrett's esophagus to help lower their chances of developing cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05983419 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with Barrett's esophagus who have developed neoplastic lesions. The study employs endoscopic submucosal dissection (ESD) to achieve complete resection of these lesions, aiming to reduce the risk of cancer development. By utilizing ESD, the trial seeks to address the limitations of current treatment methods, which often require multiple sessions and carry significant risks. The goal is to provide a more effective and less burdensome treatment option for patients with Barrett's esophagus harboring neoplasia.
Who should consider this trial
Good fit: Ideal candidates include individuals with long segment Barrett's esophagus (3-9 cm) who have confirmed neoplastic changes.
Not a fit: Patients with deep submucosal invasion, refractory esophagitis, or those on anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of cancer in patients with Barrett's esophagus.
How similar studies have performed: While initial reports on ESD for Barrett's esophagus were discouraging, ongoing advancements suggest potential for improved outcomes, indicating a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:- Long segment Barrett's esophagus with circular component \>= 3cm and maximum extent of 9cm. * Presence of neoplastic Barrett's esophagus on previous biopsies confirmed by expert pathologist. Exclusion Criteria:Refractory esophagitis * Presence of signs of deep submucosal invasion (\>sm1) * Anticoagulation therapy that cannot be discontinued (ASA allowed) * Barrett's esophagus length \> 9 cm (C and/or M) * Immunosuppression that would contraindicate use of steroids. * Diabetes Mellitus
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Francisco Baldaque-Silva Baldaque-Silva, MD PhD
- Email: fbaldaquesilva@gmail.com
- Phone: +46704997219
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.