Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT06881004
Brief Summary:
This study is a multicenter, bidirectional cohort study aimed at continuously enrolling patients with biliary dilatation from 25 medical centers in China. It will collect comprehensive life-cycle data from the cohort to establish a Chinese cohort for bile duct dilatation. Based on this cohort, the study seeks to clarify the epidemiological characteristics, pathological features, standard classification, disease progression, cancer risk, and optimal timing for surgical intervention in patients with bile duct dilatation. Additionally, it will compare the perioperative risks, long-term outcomes, and quality of life among different types of patients (including Todani types I, IVa, and V) following surgical treatment, to establish standardized surgical treatment strategies for each type.
Detailed Description:
Biliary Dilatation(BD) is a complex benign biliary disorder prevalent in East Asia, for which surgical resection remains the sole curative approach necessitating prompt intervention upon diagnosis. Nevertheless, critical aspects including disease subtyping, standardized surgical management protocols, and prognostic determinants remain inadequately defined. This multicenter ambidirectional cohort study aims to consecutively enroll BD patients across 25 tertiary medical centers in China, systematically collecting comprehensive life-cycle data encompassing demographic profiles, clinical baseline characteristics, laboratory/imaging findings, biliary-specific biomarkers, and longitudinal follow-up records to establish a nationally representative Chinese BD cohort. Building upon this cohort, the study objectives are structured as follows:
1. Establishment and Maintenance: To construct and perpetually update a multicenter clinical database for BD research in China, ensuring data integrity and accessibility.
2. Age-Stratified Comparative Analysis: To delineate and contrast the differential patterns of disease progression, surgical decision-making paradigms, and postoperative surveillance strategies between adult and pediatric BD populations.
3. Natural History Characterization: To elucidate disease trajectories, morphological evolution, comorbidity progression, malignant transformation risks, and evidence-based surgical indications/timing in non-operated asymptomatic BD patients.
4. Therapeutic Standardization: To define optimal surgical modalities (with emphasis on Todani classification types I, IVa, and V) and critically evaluate the efficacy-safety profile of standardized operative approaches through multidimensional outcome assessments.
5. Quality-of-Life Quantification: To systematically evaluate postoperative quality of life (QoL) metrics across BD subtypes and identify modifiable determinants influencing long-term patient-reported outcomes.
6. Epidemiological Benchmarking: To synthesize epidemiological patterns, establish evidence-based clinical endpoints for surgical interventions, and define reference standards for treatment-related risks and QoL benchmarks in standardized BD management.
Study:
NCT06881004
Study Brief:
Protocol Section:
NCT06881004