Efficacy and Safety of Surgical Treatment for Type IVa CBD
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 IVa biliary dilatation (BD). Based on this cohort, the study seeks to compare the perioperative risks, long-term outcomes, and quality of life of type IVa BD following surgical treatment, to establish standardized surgical treatment strategies for type IVa BD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have been diagnosed with Todani type IVa BD.
Patients aged between 0 and 80 years old, regardless of gender.
First-time receipt of surgery.
Disqualifiers
With abnormal intrapancreatic bile duct
Inappropriate Roux-loop length (outside the range of 40-60 cm for adults and 15-30 cm for children)
With non-relevant surgical interventions
Pathologically confirmed carcinogenesis
Trial population
All patients with a definitive diagnosis of Todani type IVa biliary dilation in the participating centers
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 2 trial groupsGroup A: Liver Resection Group
Group B: Hepaticojejunostomy Group
Trial outcomes
Primary outcomes
1
Long-term complication-free survival (LCFS)
For patients who have undergone surgical treatment, the occurrences of long-term postoperative complications include recurrent cholangitis, intrahepatic bile duct stones, stenosis of the bilioenteric anastomosis, and other such conditions
Time frame
After 30 or 90 days of surgerySecondary outcomes
1
Overall 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 postoperatively2
Malignant transformation rate
The occurrence of malignant transformation associated with bile duct dilatation
Time frame
Through study completion, an average of 1 year3
Mayo Score
Long-term outcome was evaluated according to the dedicated clinical evaluation score reported by the Mayo Clinic: excellent, if the patient remained free of symptoms without further reintervention; good, if the patient had occasional and mild episodes of cholangitis or pancreatitis, which were not impairing the quality of life; fair, if the patient had repeated episodes of cholangitis or pancreatitis,or portal hypertension without further reintervention; poor, if the patient required later biliary or liver-related surgical procedures, developed biliary cirrhosis or complications because of portal hypertension, or died from cyst-related malignancy or liver and biliary-related complications.
Time frame
Through study completion, an average of 6 months4
Severe perioperative complication rate
The occurrence of severe perioperative complications (Clavien-Dindo grading ≥ III), 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