Surgical options for Type IVa choledochal cyst (biliary dilatation)
The Efficacy and Safety of Surgical Treatment in Type IVa Congenital Biliary Dilation: A Multi-center Cohort Study
This project will compare two surgical approaches to see which gives better short- and long-term outcomes for people with Type IVa choledochal cyst.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | N/A to 80 Years |
| Sex | All |
| Sponsor | Beijing Tsinghua Chang Gung Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07036848 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, bidirectional cohort enrolling patients with Type IVa biliary dilatation across centers in China to collect comprehensive life‑cycle clinical data. The cohort will capture perioperative details, complications, long‑term outcomes, and patient-reported quality of life after surgery. Analyses will compare outcomes following hepaticojejunostomy versus hepatectomy to characterize perioperative risk, late complications (like intrahepatic stones or anastomotic stricture), and rates of disease regression. The goal is to use these real‑world data to inform and standardize surgical treatment strategies for Type IVa biliary dilatation.
Who should consider this trial
Good fit: Ideal candidates are people aged 0–80 with a first‑time diagnosis of Todani Type IVa biliary dilatation who are undergoing surgical treatment and can commit to follow-up.
Not a fit: Patients with abnormal intrapancreatic bile ducts, pathologically confirmed cancer, unresolved stones or strictures at the time of surgery, inappropriate Roux limb length, other non‑relevant surgical interventions, or unavailable follow-up data are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could help surgeons choose safer operations and improve long‑term outcomes and quality of life for patients with Type IVa biliary dilatation.
How similar studies have performed: Previous small series and retrospective reports give mixed results—some suggest intrahepatic ducts may regress after hepaticojejunostomy while others report long‑term complications, and hepatectomy has limited case‑series support.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have been diagnosed with Todani type IVa BD. 2. Patients aged between 0 and 80 years old, regardless of gender. 3. First-time receipt of surgery. Exclusion Criteria: 1. With abnormal intrapancreatic bile duct 2. Inappropriate Roux-loop length (outside the range of 40-60 cm for adults and 15-30 cm for children) 3. With non-relevant surgical interventions 4. Pathologically confirmed carcinogenesis 5. Unresolved choledocholithiasis, bile duct stenosis, and Intrahepatic bile duct stones during the procedure. 6. Unavailable follow-up information.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Shuo Jin, PhD — Beijing Tsinghua Changgeng Hospital
- Study coordinator: Changzhen Yang, MD
- Email: ycz23@mail.tsinghua.edu.cn
- Phone: +86 18810915262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.