Comparing blind spots of unsedated ultrafine, sedated, and unsedated conventional gastroscopy with and without artificial intelligence: a prospective, single-blind, 3-parallel-group, randomized, single-center trial

Abstract

Background and aims: EGD is the most vital procedure for the diagnosis of upper GI lesions. We aimed to compare the performance of unsedated ultrathin transoral endoscopy (U-TOE), unsedated conventional EGD (C-EGD), and sedated C-EGD with or without the use of an artificial intelligence (AI) system.

Methods: In this prospective, single-blind, 3-parallel-group, randomized, single-center trial, 437 patients scheduled to undergo outpatient EGD were randomized to unsedated U-TOE, unsedated C-EGD, or sedated C-EGD, and each group was then divided into 2 subgroups: with or without the assistance of an AI system to monitor blind spots during EGD. The primary outcome was the blind spot rate of these 3 groups with the assistance of AI. The secondary outcomes were to compare blind spot rates of unsedated U-TOE, unsedated, and sedated C-EGD with or without the assistance of AI, respectively, and the concordance between AI and the endoscopists' review.

Results: The blind spot rate with AI-assisted sedated C-EGD was significantly lower than that of unsedated U-TOE and unsedated C-EGD (3.42% vs 21.77% vs 31.23%, respectively; P < .05). The blind spot rate of the AI subgroup was lower than that of the control subgroup in all 3 groups (sedated C-EGD: 3.42% vs 22.46%, P < .001; unsedated U-TOE: 21.77% vs 29.92%, P < .001; unsedated C-EGD: 31.23% vs 42.46%, P < .001).

Conclusions: The blind spot rate of sedated C-EGD was the lowest among the 3 types of EGD, and the addition of AI had a maximal effect on sedated C-EGD. (Clinical trial registration number: ChiCTR1900020920.).