Diagnostic Performance of Computed Tomography-Based Artificial Intelligence for Early Recurrence of Cholangiocarcinoma: Systematic Review and Meta-Analysis.

Background: Despite artificial intelligence (AI) models demonstrating high predictive accuracy for early cholangiocarcinoma recurrence, their clinical application faces challenges, such as reproducibility, generalizability, hidden biases, and uncertain performance across diverse datasets and populations, raising concerns about their practical applicability.

Objective: This meta-analysis aims to systematically assess the diagnostic performance of AI models using computed tomography (CT) imaging to predict early recurrence of cholangiocarcinoma.

Methods: A systematic search was conducted in PubMed, Embase, and Web of Science for studies published up to May 2025. Studies were selected based on the Participants, Index test, Target condition, Reference standard, Outcomes, and Setting (PITROS) framework. Participants included patients diagnosed with cholangiocarcinoma (including intrahepatic and extrahepatic locations). The index test was AI techniques applied to CT imaging for early recurrence prediction (defined as within 1 year), while the target condition was early recurrence of cholangiocarcinoma (positive group: recurrence; negative group: no recurrence). The reference standard was pathological diagnosis or imaging follow-up confirming recurrence. Outcomes included sensitivity, specificity, diagnostic odds ratio (DOR), and area under the receiver operating characteristic curve (AUC), assessed in both internal and external validation cohorts. The setting comprised retrospective or prospective studies using hospital datasets. Methodological quality was assessed using an optimized version of the revised Quality Assessment of Diagnostic Accuracy Studies-2 tool. Heterogeneity was assessed using the I² statistic. Pooled sensitivity, specificity, DOR, and AUC were calculated using a bivariate random-effects model.

Results: A total of 9 studies with 30 datasets involving 1537 patients were included. In internal validation cohorts, CT-based AI models showed a pooled sensitivity of 0.87 (95% CI 0.81-0.92), specificity of 0.85 (95% CI 0.79-0.89), DOR of 37.71 (95% CI 18.35-77.51), and AUC of 0.93 (95% CI 0.90-0.94). In external validation cohorts, pooled sensitivity was 0.87 (95% CI 0.81-0.91), specificity was 0.82 (95% CI 0.77-0.86), DOR was 30.81 (95% CI 18.79-50.52), and AUC was 0.85 (95% CI 0.82-0.88). The AUC was significantly lower in external validation cohorts compared to internal validation cohorts (P<.001).

Conclusions: Our results show that CT-based AI models predict early cholangiocarcinoma recurrence with high performance in internal validation sets and moderate performance in external validation sets. However, the high heterogeneity observed may impact the robustness of these results. Future research should focus on prospective studies and establishing standardized gold standards to further validate the clinical applicability and generalizability of AI models.