Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 102218, China
Location status: Recruiting
Location contact
Changzhen Yang, MD
CONTACT
Shuo Jin, PhD
CONTACT
NCT Number: NCT06881004
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.
Interested in participating?
Request InfoUp to 80 year
All sexes
Observational
Beijing, Beijing Municipality, 102218, China
Location status: Recruiting
Changzhen Yang, MD
CONTACT
Shuo Jin, PhD
CONTACT
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: After 30 or 90 days of surgery
For patients who have undergone surgical treatment, the occurrences of long-term postoperative complications include recurrent cholangitis, pancreatitis, bile duct stones, liver failure, and other such conditions.
Time frame: through study completion, an average of 10 year
The occurrence of malignant transformation associated with bile duct dilatation
Time frame: Within 30 or 90 days postoperatively
The occurrence of perioperative complications, including bile leakage, pancreatic leakage, liver failure, bacteremia, abdominal fluid accumulation, and intra-abdominal infections, among others.
Contact information is provided by the study sponsor or research team.
Changzhen Yang, MD
CONTACT
Shuo Jin, PhD
CONTACT
Beijing Tsinghua Chang Gung Hospital
Other
Establishment and Evaluation of Clinical Classification and Surgical Decision-making System for Biliary Dilatation:a National Special Disease Cohort Study in China
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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