Evaluating a new technique for treating Barrett's Esophagus-related dysplasia
Efficacy and Safety of HYbrid Argon Plasma Coagulation Technique in Patients With Barrett's Esophagus-Related Dysplasia: a Multicenter Italian Prospective stuDy
This study is testing a new treatment method for people with Barrett's Esophagus-related dysplasia to see if it is safer and more effective than current options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT05645679 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the efficacy and safety of the Hybrid Argon Plasma Coagulation technique in patients diagnosed with Barrett's Esophagus-related dysplasia. Barrett's Esophagus is a pre-malignant condition that can progress to esophageal cancer, and current treatments like radiofrequency ablation have notable complications and costs. The study aims to assess the outcomes of this new technique in patients with low-grade or high-grade dysplasia after endoscopic resection. Participants will be monitored for treatment effectiveness and safety over the course of the study.
Who should consider this trial
Good fit: Ideal candidates include adults with histopathologically confirmed low-grade or high-grade dysplasia or residual Barrett's Esophagus after endoscopic resection.
Not a fit: Patients with severe medical comorbidities, esophageal stenosis, or those who have undergone previous ablation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could provide a safer and more effective treatment option for patients with Barrett's Esophagus-related dysplasia.
How similar studies have performed: While radiofrequency ablation has been well-studied, the Hybrid Argon Plasma Coagulation technique is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Patients with histopathologically confirmed LGD or HGD, or residual BE (Prague Classification ≤C3 / ≤M5) after endoscopic resection of a focal lesion containing LGD, HGD or early (≤T1sm1) cancer in the participating centres are eligible for study participation. Exclusion Criteria: * Younger than 18 years of age at time of consent * Esophageal stenosis preventing advancement of a therapeutic endoscope * Prior distal oesophagectomy * Previous ablation therapy of the esophagus * Active oesophagitis grade B or higher (patients can be included after appropriate treatment of reflux oesophagitis) * History of oesophageal varices * Achalasia * Severe medical comorbidities precluding endoscopy * Uncontrolled coagulopathy * Pregnant or planning to become pregnant during period of study participation * Life expectancy ≤2 years, as judged by the site investigator
Where this trial is running
Milano
- Humanitas Research Hospital — Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Repici, MD
- Email: alessandro.repici@humanitas.it
- Phone: 0039-02-82247493
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.