Jipeng Zheng, Yibei Tang, Yang Gao, Yihan Sun, Gang Li, Xiang Fei, Xuanyu Chen, Wanli Zheng, Liangliang Zhu, Jingyao Yu, Yu Zhou, Yaqin Wu, Chaojie Zhang, Xingai Ju, Dongxiao Zhang, Jianchun Cui
The proposed CDOP-PFN classification and management framework standardizes the recognition and handling of complex ductoscopy operating scenarios. These strategies may reduce dependency on individual operator experience, improve procedural standardization and safety, enhance diagnostic yield for intraductal lesions, and advance minimally invasive breast disease management.
OBJECTIVE: To systematically review the literature on ductoscopy-related operative failures, establish a classification system for "Complex Ductoscopy Operating Procedure (CDOP)", and propose standardized clinical response strategies.
METHODS: A comprehensive search of PubMed, Embase, Web of Science, Scopus, and Cochrane Library was conducted for publications from January 1991 to July 2026. Causes of ductoscopy failure were extracted, categorized, and quantitatively summarized. The methodological quality of included studies was evaluated. Based on literature evidence and accumulated clinical experience, a standard CDOP-PFN (Passing, Finding, Non-discharge) classification system and stepwise clinical management framework were developed.
RESULTS: From 25 included studies (2,853 procedures), meta-analysis showed a pooled failure rate of 10.0% (95%CI: 6.8%-13.7%; 95% PI: 0.0%-31.4%) with high heterogeneity (I² = 87.1%). Primary causes were ductal perforation (22.5%), ductal stenosis (21.9%), and nipple deformity/retraction (12.1%). Failures were stratified into three major types (PFN): (i) presence of nipple discharge with inability to access the ductal system via ductoscopy (type P, passing); (ii) bloody discharge with failure to identify intraductal lesions (type F, finding); and (iii) absence of spontaneous discharge but ultrasonographic evidence of ductal dilatation and intraductal lesions (type N, non-discharge). For each type, a tiered strategy was formulated, incorporating pre-procedural evaluation, duct entry optimization, image-guided localization, troubleshooting, and surgical approaches when needed.
CONCLUSION: The proposed CDOP-PFN classification and management framework standardizes the recognition and handling of complex ductoscopy operating scenarios. These strategies may reduce dependency on individual operator experience, improve procedural standardization and safety, enhance diagnostic yield for intraductal lesions, and advance minimally invasive breast disease management.