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| Korean J Helicobacter Up Gastrointest Res > Volume 26(3); 2026 > Article |
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| Study | Country; centers | Design | Patients analyzed (AI/control) | Endoscopist experience | AI system (function) | Imaging modality | Reference standard | Primary outcome | Key findings |
|---|---|---|---|---|---|---|---|---|---|
| Wu et al. [28] (2021) | China; 5 tertiary centers | Prospective, single-blind, parallel-group RCT; per protocol | 1002 (498/504) | 14 endoscopists, 3–5 y of EGD experience (2000–5000 EGD examinations) | ENDOANGEL (quality control: blind-spot monitoring, timing; plus real-time EGC prediction) | WLI; M-IEE permitted for suspicious lesions | Histopathology; no centralized review (discordant cases reviewed by a single expert pathologist) | Number of blind spots; EGC prediction was one of the secondary outcomes | Blind spots 5.38 vs. 9.82 (p<0.001); inspection time 5.40 min vs. 4.38 min (p<0.001). In an exploratory analysis of 196 gastric lesions with pathology, per-lesion accuracy was 84.7%, sensitivity 100% (5/5 cancers or HGIN), and specificity 84.3%. |
| Wu et al. [29] (2021) | China; single center | Prospective, same-day tandem RCT (AI-first vs. routine-first); per-protocol | 1812 (907/905) | 6 endoscopists: 2 junior (1 y, >2000 examinations), 4 senior (3–5 y, >5000 examinations) | ENDOANGEL-LD v2.0 (lesion detection and characterization; blue box=focal lesion, red box=suspected neoplasm) | WLI | Histopathology (revised Vienna classification), 2 pathologists with >10 y experience | Gastric neoplasm miss rate (per-lesion) | Miss rate 6.1% (3/49) vs. 27.3% (12/44); RR 0.224 (95% CI 0.068–0.744), p=0.015. Biopsy rate was lower (17.0% vs. 35.9%) and PPV higher (25.0% vs. 8.4%) with AI. |
| Zhou et al. [38] (2024) | China; 6 centers (3 academic, 3 non-academic) | Prospective, single-blinded RCT; per-protocol | 1829 (914/915) | 4 endoscopists per center; 2 experienced (≥5 y, ≥3000 procedures) and 2 less experienced | IQCS (quality control: inspection completeness, mucosal visibility, inspection time; plus lesion detection) | WLI; IEE or chromoendoscopy at operator discretion | Histopathology (revised Vienna classification) by 3 experienced pathologists (>10 y) at a single center | Detection rate of early UGI neoplasms | 6.1% (56/914) vs. 2.3% (21/915), p=0.0001. Benefit was seen in both non-academic (RR 3.32) and academic centers (RR 2.42), and in both less-experienced (RR 2.65) and experienced endoscopists (RR 2.71). Blind spots 2.3 vs. 6.2, p<0.0001; inspection time and biopsy rate unchanged. |
| Chen et al. [39] (2025) | China; 7 centers | Prospective, multicenter RCT; per-protocol | 32017 (16012/16005) | 2 endoscopists per center with 3–5 y of EGD experience and >5000 examinations | EQCA (quality control: 31-site coverage, inspection time, operation score; plus lesion detection) | WLI | Histopathology of biopsy specimens; no centralized review | Detection rate of UGI cancer-related lesions (LGIN and HGIN), and cancer (early and advanced cancer) | Cancer-related lesions 8.00% vs. 5.55% and cancer 1.93% vs. 1.21% (both p<0.001). For gastric lesions, 6.26% vs. 4.10% (p<0.001); gains were confined to the cardia (or fundus) and the body, with no difference in the angulus or antrum (or pylorus). Only patients with one lesion at a single site were included. |
| Xu et al. [37] (2025) | China; single center | Prospective, single-blinded, randomized trial with a baseline (pretest) and a post-intervention (post-test) phase (4 subgroups); intention-to-treat* | 1968 gastroscopies (492 per subgroup) | 2 experts (>5 y, >1000 EGD/y) and 6 endoscopists with 1–3 y (>800 EGD/y) | ENDOANGEL (quality control: blind-spot model, timing, scoring; plus lesion detection with red or blue frames) | WLI | Histopathology graded by the updated Sydney system (pathologists ≥10 y); protocol mandated 5 non-targeted biopsies in both arms | Detection rate of gastric precancerous lesions (atrophy or intestinal metaplasia) | Intestinal metaplasia 14.23% vs. 9.15% (RR 1.56, p=0.013) and atrophy 22.76% vs. 17.28% (RR 1.32, p=0.031). The benefit was significant only among junior endoscopists (RR 1.58 and 1.44); among senior endoscopists neither reached significance. Blind-spot rate 7.84% vs. 11.19% (RR 0.70, p=0.007); biopsy rate and examination time increased. |
| Dong et al. [34] (2026) | China; 24 centers in 12 provinces | Prospective, multicenter, patient-blinded, parallel-group RCT; ITT and per-protocol | 29514 (ITT) (14767/14747) | 110 endoscopists (17 junior, 12 mid-level, 30 senior, 51 expert); 82.9% of procedures at tertiary hospitals | ENDOANGEL-GN (quality control and lesion detection or characterization integrated in one device) | WLI; IEE at operator discretion for suspicious lesions | Histopathology with prespecified centralized pathologic review by expert panels | Detection rate of gastric neoplasms after centralized pathologic review | No difference after review: 1.42% vs. 1.25%; RR 1.13 (95% CI 0.92–1.38), p=0.25. With local pathology alone the difference was significant (4.06% vs. 3.57%; RR 1.14, p=0.03). On review, 83.6% of LGIN and 14.0% of HGIN were downgraded to benign. Blind spots 1.07 vs. 2.52 (p<0.001); procedure and inspection time were prolonged (p<0.001). Benefit was suggested only for endoscopists with <3 y of experience (RR 1.83) and during fatigue periods. |
Studies are listed in chronological order of publication. All reported outcomes are for the comparison of AI-assisted versus unassisted endoscopy. Table 1 is restricted to randomized trials of AI for the detection of gastric malignant or premalignant lesions, and is therefore not identical to the 11 trials pooled in the meta-analysis of Al Hayek et al. [24] Of those 11 trials, four evaluated esophageal neoplasms exclusively, and in three others the AI system performed endoscopic quality control only, without a lesion detection function; the remaining four appear in this table. Two trials listed here (Xu et al. [37] 2025; Dong et al. [34] 2026) were not included in that meta-analysis.
* Xu et al. [37] randomly allocated patients to a control and an experimental arm and compared each arm between a baseline (pretest) phase and a post-intervention (post-test) phase, with the AI system used only in the experimental arm during the post-intervention phase (experimental group ii). The estimates shown in the table are comparisons between experimental group ii and control group ii.
AI, artificial intelligence; CI, confidence interval; EGC, early gastric cancer; EGD, esophagogastroduodenoscopy; EQCA, endoscopy quality control assistant; HGIN, high-grade intraepithelial neoplasia; IEE, image-enhanced endoscopy; IQCS, intelligent quality-control system; ITT, intention-to-treat; LGIN, low-grade intraepithelial neoplasia; M-IEE, magnifying image-enhanced endoscopy; PPV, positive predictive value; RCT, randomized controlled trial; RR, relative risk; UGI, upper gastrointestinal; WLI, white-light imaging.
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