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

Background: Dilation in patients with malignant esophageal strictures precluding the passage of the endoscopic ultrasonography (EUS) scope allows complete evaluation; however, it 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 before 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 for 18 patients (34%) and a deviation in the treatment plan in 7 patients (13.2%). No differences were found in these variables when compared with the group that did not require dilation (26.3% and 14.7%, P = .33 and P = .79, respectively). Dilation was associated with more advanced disease on final pathology among patients who underwent surgical resection (P = .006). Conclusions: High-grade malignant esophageal strictures that preclude the passage of the ultrasound probe are associated with advanced stage disease. Owing to the high risk of perforation and the limited benefit in staging, balloon dilation to complete the EUS staging should be avoided. (Clinicaltrials.gov identifier: NCT01950442.)