Efficacy and Safety of HYbrid Argon Plasma Coagulation Technique in Patients With Barrett's Esophagus-Related Dysplasia

Launched by ISTITUTO CLINICO HUMANITAS · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment technique called Hybrid Argon Plasma Coagulation (H-APC) for patients with Barrett's Esophagus, which is a condition that can lead to cancer if not treated. The trial aims to see if H-APC is effective and safe for people who have low-grade or high-grade dysplasia, which means they have abnormal cells that could become cancerous. This technique is being tested because current treatments like radiofrequency ablation can have significant side effects and high costs.

To participate in the trial, patients must be between 65 and 74 years old and have a confirmed diagnosis of Barrett's Esophagus with either low-grade or high-grade dysplasia. Certain conditions, such as having had previous esophagus surgery or severe health issues, may exclude someone from joining. Participants will receive the H-APC treatment and will be monitored for its effectiveness and any side effects. This trial is important because it could provide a safer and more effective option for treating Barrett's Esophagus, helping to reduce the risk of cancer.

Gender

ALL

Eligibility 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