Trial Information

Endoscopy Screening for Esophageal Neoplasm With Narrow Band Imaging in Patients With Head and Neck Cancer: A Controlled Tandem Endoscopy Trial

This is a prospective blinded controlled tandem endoscopy trial conducted in a regional
medical center (Lotung Poh-Ai Hospital, Taiwan). Patients with tissue diagnosis of head and
neck cancer are enrolled. Endoscopy screening for esophageal lesions is first performed by
using the conventional white light system. Suspicious lesions are recorded. Then the entire
esophagus is examined under the NBI system by another endoscopist, who is blinded to the
result of the conventional endoscopy. After the endoscopic inspection completed, all
suspicious lesions are biopsied. Before each procedure, which one of the two participating
endoscopists applies the conventional or NBI system is randomized. The diagnostic rate of
esophageal neoplasm by the conventional white light system and that of the NBI system are
compared.

The endpoint is the neoplastic lesion detected on endoscopic biopsy. We considered invasive
cancer, carcinoma in-situ, and high-grade dysplasia (which usually cannot be distinguished
from carcinoma in situ) as the primary points. Any dysplastic lesions were considered as
secondary points.