Caroli DiseaseNCT07903090
Hepatectomy in Caroli Disease
An observational study of Caroli Disease, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
using the largest multicenter cohort of CD patients undergoing LR to date, we developed and validated a prognostic nomogram with an online calculator to preoperatively predict LCFS for LR candidacy assessment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Caroli Disease
- How many people
- 171 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible patients were those with CD who had adequate hepatic functional reserve and underwent first-time LR.
Who may be able to join
- CD patients
- Adequate hepatic functional reserve
- Underwent first-time LR
Who cannot join
- Pathologically confirmed carcinogenesis identified perioperatively;
- Unavailable or incomplete clinical data;
- Unavailable follow-up information;
- Unresolved comorbidities after LR;
- Combined with other surgeries;
- Death within 3 months after LR.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
About this study
Official title: A Prognostic Nomogram for Preoperative Assessment of Hepatectomy Candidacy in Caroli Disease: A Nationwide, Multicenter Cohort Study
using the largest multicenter cohort of CD patients undergoing LR to date, we developed and validated a prognostic nomogram with an online calculator to preoperatively predict LCFS for LR candidacy assessment. The model supports identification of patients most likely to benefit from LR and provides a practical tool for individualized surgical decision-making in this rare benign disease.
Read the detailed description
Background: To develop and validate a prognostic nomogram for preoperatively assessing candidacy for liver resection (LR) in Caroli disease (CD).CD is a rare benign biliary disease, for which LR represents the most commonly applied surgical treatment. However, indications of LR remain unclear, and long-term complications frequently occur after LR.
Methods: We conducted a nationwide, multicenter cohort study to develop a prognostic nomogram across 10 centers. Patients with CD undergoing LR were included and randomly assigned to derivation (70%) and validation (30%) cohorts. The endpoint was postoperative long-term complication-free survival (LCFS). Three prognostic models were developed and compared: multivariable Cox model, LASSO-Cox model and best subset selection model. A nomogram with online calculator was developed from the final model, and patients were stratified into favorable and unfavorable candidates for LR based on nomogram score.
- Conditions
- Caroli Disease
- Keywords
- Caroli disease, Liver resection, Nomogram, Risk stratification, Long-term complications
- Medical subject headings
- Caroli Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatectomy in Caroli Disease | Patients diagnosed with Caroli patients and underwent liver resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative long-term complication-free survival
Long-term complications were defined as the first occurrence of any clinically significant complication ≥3 months after LR, including hepatolithiasis, recurrent cholangitis, liver failure, or biliary carcinogenesis.
Measured: Follow-up was conducted every 3 to 6 months for the first two years after surgery, and on an annual basis thereafter. Time zero was postoperative Day 1. Time period was through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2025
- Primary completion1 Jan 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caroli DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuo Jin, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903090
- Sponsor's protocol ID
- S02455-02
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Concerning patient privacy.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prognostic Nomogram for Preoperative Assessment of Hepatectomy Candidacy in Caroli Disease: A Nationwide, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07903090
- Acronym / sponsor ID
- S02455-02
- Conditions
- Caroli Disease
- Keywords
- Caroli disease, Liver resection, Nomogram, Risk stratification, Long-term complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
using the largest multicenter cohort of CD patients undergoing LR to date, we developed and validated a prognostic nomogram with an online calculator to preoperatively predict LCFS for LR candidacy assessment. The model supports identification of patients most likely to benefit from LR and provides a practical tool for individualized surgical decision-making in this rare benign disease.
Detailed description
Background: To develop and validate a prognostic nomogram for preoperatively assessing candidacy for liver resection (LR) in Caroli disease (CD).CD is a rare benign biliary disease, for which LR represents the most commonly applied surgical treatment. However, indications of LR remain unclear, and long-term complications frequently occur after LR.
Methods: We conducted a nationwide, multicenter cohort study to develop a prognostic nomogram across 10 centers. Patients with CD undergoing LR were included and randomly assigned to derivation (70%) and validation (30%) cohorts. The endpoint was postoperative long-term complication-free survival (LCFS). Three prognostic models were developed and compared: multivariable Cox model, LASSO-Cox model and best subset selection model. A nomogram with online calculator was developed from the final model, and patients were stratified into favorable and unfavorable candidates for LR based on nomogram score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatectomy in Caroli Disease | – | –Patients diagnosed with Caroli patients and underwent liver resection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients were those with CD who had adequate hepatic functional reserve and underwent first-time LR.
Key inclusion criteria (3 listed)
- CD patients
- Adequate hepatic functional reserve
- Underwent first-time LR
Key exclusion criteria (6 listed)
- Pathologically confirmed carcinogenesis identified perioperatively;
- Unavailable or incomplete clinical data;
- Unavailable follow-up information;
- Unresolved comorbidities after LR;
- Combined with other surgeries;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative long-term complication-free survival
Time frame: Follow-up was conducted every 3 to 6 months for the first two years after surgery, and on an annual basis thereafter. Time zero was postoperative Day 1. Time period was through study completion, an average of 3 years.
Long-term complications were defined as the first occurrence of any clinically significant complication ≥3 months after LR, including hepatolithiasis, recurrent cholangitis, liver failure, or biliary carcinogenesis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. Concerning patient privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caroli Disease, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative long-term complication-free survival (time frame: Follow-up was conducted every 3 to 6 months for the first two years after surgery, and on an annual basis thereafter. Time zero was postoperative Day 1. Time period was through study completion, an average of 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.