Study of Oral Itraconazole Combined With Endoscopic Radiofrequency Ablation to Prevent Esophageal Cancer in Patients With High-Risk Barretts Esophagus

What this Trial Is About

Researchers are studying itraconazole combined with standard endoscopic ablation to prevent esophageal cancer in patients with high-risk Barretts esophagus BE, a condition where the esophagus lining changes and increases cancer risk. This phase II trial aims to see if itraconazole can speed up the complete removal of abnormal intestinal tissue compared to standard treatment alone. The study also looks at safety, treatment response, and biological effects related to certain signaling pathways. Participants are randomly assigned to receive either itraconazole or a placebo twice daily by mouth for 42 days per cycle, up to two cycles, alongside regular endoscopy and radiofrequency ablation to remove abnormal tissue. Blood samples and tissue biopsies are collected throughout the study to monitor drug levels and treatment effects. After treatment, participants are followed for 12 months to observe recurrence and long-term outcomes. During the study, participants undergo scheduled endoscopies with tissue biopsies and blood draws to assess treatment progress. Questionnaires measure the biosocial impact of treatment. Researchers track the time to complete eradication of intestinal metaplasia and dysplasia, adverse events, and recurrence rates. These assessments help evaluate itraconazoles potential to enhance ablation effects and prevent esophageal cancer in high-risk patients over the study duration.

Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus