Comparing two techniques for removing cancerous lesions in Barrett's esophagus
Prospektiv-randomisierter Vergleich Von En-bloc- Versus Piecemeal-Resektion Von Barrett Neoplasien Des Ösophagus Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection
This study is testing which of two methods for removing cancerous lesions in Barrett's esophagus works better and has fewer risks for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 407 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 2 sites (Orlando, Florida and 1 other locations) |
| Trial ID | NCT03427346 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness and risks of two endoscopic techniques, Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD), for treating Barrett's esophagus with neoplasia. Both techniques aim to remove dysplastic or malignant lesions while minimizing invasiveness. The study will evaluate long-term outcomes and complications associated with each method, as well as their efficacy when combined with subsequent ablative therapy. The goal is to determine which technique provides better results for patients with Barrett's esophagus.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with Barrett's esophagus who require mucosal resection and have lesions that can be treated with either EMR or ESD.
Not a fit: Patients with lesions that are too large, suspected deep infiltration, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with Barrett's esophagus, potentially reducing the risk of cancer recurrence.
How similar studies have performed: Previous studies have shown promising results with both EMR and ESD techniques, indicating that this comparative approach is relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients to be treated for Barrett's esophagus by mucosal resection and following ablative therapy * Barrett's mucosal extension up to 10 cm maximum. * patient's ability for compliance to therapy * signed Informed Consent Exclusion Criteria: * any lesion questionable to be resectable by mucosectomy, e.g. bulky lesions ≥10 mm in endoscopy und endosonography, suspected deep submucosal infiltration, ulcers, suspected or by FNA confirmed lymph node infiltration * Barrett's esophagus \> 10 cm * lesions that would afford resection of more than 2/3rd of esophagal circumference * two or more single Barrett's lesions with bulky HGIN or early cancer histology, not to be resectable in one half of esophageal circumference * planned circumferencial resections * very serious general illness and metastatic carcinoma * coagulation disorder or anticoagulants that make biopsies and resections impossible * American Society of Anesthesiologists (ASA) status \> III * pregnancy and lactation * remainders or recurrences after therapeutic history of Barrett's espohagus
Where this trial is running
Orlando, Florida and 1 other locations
- Orlando Health — Orlando, Florida, United States (Recruiting)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Thomas Rösch, Prof. Dr. — Ph D, Director, Head of department
- Study coordinator: Thomas Rösch, Prof. Dr.
- Email: t.roesch@uke.de
- Phone: + 49 40 7410
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.