Biliary Dilatation National Special Disease Cohort in China
ConditionCholedochal Cyst
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 80
SponsorBeijing Tsinghua Chang Gung Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have been definitive diagnosed with biliary dilation.
Patients aged between 0 and 80 years old, regardless of gender.
In line with the principle of informed consent: For the retrospective cohort of biliary dilation, exemption from signing the informed consent form is applied for, while for the prospective cohort, signing the informed consent form is required.
Disqualifiers
None
Trial population
All patients with a definitive diagnosis of biliary dilation in the participating centers will be included.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
6,000 Participants
are grouped into 2 trial groupsGroup A: Retrospective cohort
Group B: Prospective cohort
Trial outcomes
Primary outcomes
1
Long-term complications rate
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
After 30 or 90 days of surgerySecondary outcomes
1
Malignant transformation rate
The occurrence of malignant transformation associated with bile duct dilatation
Time frame
through study completion, an average of 10 year2
Perioperative complication rate
The occurrence of perioperative complications, including bile leakage, pancreatic leakage, liver failure, bacteremia, abdominal fluid accumulation, and intra-abdominal infections, among others.
Time frame
Within 30 or 90 days postoperativelySponsors and contacts
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Source ClinicalTrials.gov