Background and Study Aims: Unsedated upper endoscopy is an attractive alternative to conventional sedated endoscopy because it can reduce the cost, complications, and recovery time of the procedure. However, it has not gained widespread acceptance in the United States. A prototype 4-mm-diameter video esophagoscope is available. Our aims were to compare unsedated esophagoscopy using this 4-mm esophagoscope with conventional sedated endoscopy with regard to diagnostic accuracy and patient tolerance, to determine the optimal intubation route (transnasal vs. transoral), and to identify the predictors of tolerance of unsedated endoscopy. Patients and Methods: Outpatients presenting for conventional endoscopy were randomized to undergo unsedated esophagoscopy by either the transnasal or the transoral route, followed by conventional endoscopy. The diagnostic findings, optical quality, and patient tolerance scores were assessed. Results: A total of 137 patients were approached and 90 (65.6%) were randomized to undergo esophagoscopy by the transnasal route (n = 44) or by the transoral route (n = 46) before undergoing conventional esophagoscopy. Patient tolerance of unsedated esophagoscopy was comparable to that of conventional endoscopy. The transnasal route was better tolerated than the transoral route, except with respect to pain, and 93.2% in transnasal group and 91.3% in transoral group were willing to have the procedure again. The diagnostic accuracy of endoscopy using the 4-mm video endoscope was similar to that of standard endoscopy. Patients who tolerated the procedure well had lower preprocedure anxiety scores (29 vs. 42.5, P = 0.021) and a higher body mass index (31.5 kg/m(2) vs. 28 kg/m(2), P = 0.029) than the other patients. Conclusions: Unsedated esophagoscopy with a 4-mm esophagoscope was well tolerated and has a level of diagnostic accuracy comparable to that of conventional endoscopy. Factors associated with good tolerance of unsedated esophagoscopy were low anxiety levels, high body mass index, and use of the transnasal route. Unsedated endoscopy may be offered to a selected group of patients based on these criteria.
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