A Quasi-Experimental clinical study to evaluate the role of sirolimus in volume and stage reduction in nasopharyngeal angiofibroma : A prospective study

This study is a prospective, quasi-experimental, single-arm interventional trial conducted over two years at AIIMS New Delhi to evaluate the role of oral sirolimus in reducing the volume and stage of nasopharyngeal angiofibroma in adolescent and young adult males. Fifteen patients aged 10 to 30 years with advanced-stage tumors (Radkowski stage IIC, IIIA, or IIIB) were enrolled. After initial clinical examination and baseline investigations, contrast-enhanced MRI scans were performed to assess tumor size and stage. Patients received oral sirolimus at a dose of two milligrams per day for three months, with weekly monitoring of blood parameters and sirolimus levels. After the treatment period, a follow-up MRI was conducted to evaluate changes in tumor volume and staging. Surgery was then performed, and operative details such as duration, blood loss, and complications were recorded. Postoperative tumor specimens were examined histologically for vascularity using CD34 staining, vessel morphology, and stromal features. The findings were compared with untreated historical control samples. The primary objective was to assess tumor volume and stage reduction, while secondary objectives included evaluation of intraoperative outcomes, adverse effects of sirolimus, and histopathological changes following treatment.