HIV clinical trials · 2014
Phase I study demonstrates safety and tolerability of radiofrequency ablation (RFA) of the anal mucosa.
Клиническое исследование I фазыСтатьяПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Smulian A George, Moore Diana M, Robertson Jaime C, Kralovic Stephen M
Аннотация
BACKGROUND: Anal carcinoma is increasing in high-risk populations. Dysplasia is often distributed throughout the anal mucosa, and focal ablative techniques have high rates of recurrence.
METHODS: With the goal of eradicating dysplasia from the entire anal mucosa, we conducted a phase I dose-ranging study to determine the safety and tolerability of radiofrequency ablation (RFA). HIV-infected individuals with high-grade anal intraepithelial neoplasia underwent RFA of the anal mucosa. Patient-reported procedural and postprocedural symptoms were recorded, and mucosal healing was visually assessed.
RESULTS: Four groups of 3 subjects each were treated with incrementally increasing numbers of RF pulses (1-3) applied to a single area of anal mucosa. Two or three doses of 12 J/cm2 were found to have acceptable patient tolerance and healing of the mucosa within 4 weeks of ablation. Using these doses, 2 groups underwent ablation of 180° of contiguous mucosa. Subjects experienced a loss of 1 to 3 days of daily activities of living, 7 to 14 days of postprocedure symptoms, and mucosal healing within 4 weeks. One subject in the first treatment group had the procedure aborted due to severe procedural pain.
CONCLUSIONS: The study provides evidence of the safety and tolerability of anal RFA of 180° of contiguous mucosa in a single procedure and will allow future RFA efficacy studies in the treatment of anal dysplasia.
METHODS: With the goal of eradicating dysplasia from the entire anal mucosa, we conducted a phase I dose-ranging study to determine the safety and tolerability of radiofrequency ablation (RFA). HIV-infected individuals with high-grade anal intraepithelial neoplasia underwent RFA of the anal mucosa. Patient-reported procedural and postprocedural symptoms were recorded, and mucosal healing was visually assessed.
RESULTS: Four groups of 3 subjects each were treated with incrementally increasing numbers of RF pulses (1-3) applied to a single area of anal mucosa. Two or three doses of 12 J/cm2 were found to have acceptable patient tolerance and healing of the mucosa within 4 weeks of ablation. Using these doses, 2 groups underwent ablation of 180° of contiguous mucosa. Subjects experienced a loss of 1 to 3 days of daily activities of living, 7 to 14 days of postprocedure symptoms, and mucosal healing within 4 weeks. One subject in the first treatment group had the procedure aborted due to severe procedural pain.
CONCLUSIONS: The study provides evidence of the safety and tolerability of anal RFA of 180° of contiguous mucosa in a single procedure and will allow future RFA efficacy studies in the treatment of anal dysplasia.