Surgical options for Type IVa choledochal cyst (biliary dilatation)
Official title: The Efficacy and Safety of Surgical Treatment in Type IVa Congenital Biliary Dilation: A Multi-center Cohort Study
Run by Beijing Tsinghua Chang Gung Hospital · NCT07036848 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 80 Years |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Beijing Tsinghua Chang Gung Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | July 14, 2025 |
| Main results expected | July 14, 2025 |
| Study ends | July 1, 2035 |
| Registry record updated | July 17, 2025 |
| Trial ID | NCT07036848 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.