Balloon Dilation for Endosonographic Staging in Esophageal Cancer - A Phase 1 Clinical Trial.

Abstract Background Dilation in patients with malignant esophageal strictures precluding the passage of the Endoscopic Ultrasound (EUS) scope allows complete evaluation, however, may be associated with complications. This study evaluates the safety and clinical value of balloon dilation to complete EUS in patients with stenotic esophageal cancers. Methods This study consists of a phase I clinical trial. One-hundred-and fifty patients were recruited. Endoscopic balloon dilation was performed prior to EUS in patients with high-grade stenosis. The analysis was focused on the ability to complete an endosonographic examination after dilation, 30-day morbidity and change in the final stage or definitive management based on the completed endosonographic examination. Results Dilation was required in 55 patients (36.7%) with a complication rate of 10.9% (N=6). Dilation allowed completion of EUS in 53 patients (96.4%), leading to a modification of the clinical stage and a deviation in the treatment plan in 18 (34%) and 7 (13.2%) patients, respectively. No differences were found in these parameters when compared with the group that did not require dilation (26.3% and 14.7%, p=0.33 and 0.79, respectively). Dilation was associated with more advance disease on final pathology among patients that underwent surgical resection (p=0.006). Conclusions High-grade malignant esophageal strictures that preclude the passage of the ultrasound probe are associated with advanced stage disease. Due to the high risk of perforation and the limited benefit in staging, balloon dilation to complete the EUS staging should be avoided.