Establishment and Evaluation of Clinical Classification and Surgical Decision-making System for Biliary Dilatation: A National Special Disease Cohort Study in China

What this Trial Is About

This research aims to establish a national cohort in China to study biliary dilatation, a complex benign bile duct disorder common in East Asia. By enrolling patients from 25 medical centers, the study will clarify the disease's epidemiology, pathological features, classification, progression, cancer risk, and the best timing for surgery. It will also compare outcomes among different types of biliary dilatation to develop standardized surgical treatment strategies. The study includes both retrospective and prospective cohorts. Retrospectively, it collects past clinical and prognostic data from previously diagnosed patients. Prospectively, it enrolls newly diagnosed patients and follows them over time to observe outcomes and surgical effects. The focus is on patients with Todani types I, IVa, and V biliary dilatation, analyzing perioperative risks, long-term complications, and quality of life after surgery. Participants will have their demographic, clinical, laboratory, imaging, and biomarker data collected throughout their care. Researchers will monitor disease progression, surgical decision-making, postoperative complications, malignant transformation, and patient quality of life over many years. The primary outcome is the rate of long-term complications after surgery, with secondary outcomes including cancer development and perioperative complications. The study will run through 2035, providing long-term follow-up data.

Biliary Dilatation National Special Disease Cohort in China