Choledochal CystNCT07036848
Efficacy and Safety of Surgical Treatment for Type IVa CBD
An observational study of Choledochal Cyst, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Choledochal Cyst
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2025to 1 Jul 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a definitive diagnosis of Todani type IVa biliary dilation in the participating centers
Who may be able to join
- 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.
Who cannot join
- 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
- Unresolved choledocholithiasis, bile duct stenosis, and Intrahepatic bile duct stones during the procedure.
- Unavailable follow-up information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Shuo Jin, M.D., +86 18810915262, 809262038@qq.com
About this study
Official title: The Efficacy and Safety of Surgical Treatment in Type IVa Congenital Biliary Dilation: A Multi-center Cohort Study
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.
Read the detailed description
Biliary dilatation (BD) is a common complex benign biliary disease. The incidence rate in Asia is one of every 1000 individuals, and the incidence rate in Europe and America is about one of every 50,000-150,000 individuals. Type IVa BD was the most commonly intrahepatic BD and the second most commonly identifiable cyst type. According to the Todani classification of congenital type IVa represents a combination of intra-and extrahepatic cystic ectasias.
However, there is still significant controversy regarding the surgical treatment approaches for this disease. Current treatment methods mainly include hepaticojejunostomy and hepatectomy. On the one hand, studies suggest that performing hepaticojejunostomy while relieving hilar bile duct stricture is sufficient. Previous research has reported that intrahepatic bile duct cysts may regress after hepaticojejunostomy. However, recent studies have described that type IV-A bile duct (BD) patients may develop long-term complications such as intrahepatic bile duct stones, anastomotic stricture, and cholangitis after hepatojejunostomy, although the specific incidence rates remain unclear. On the other hand, only a few small-series studies have reported that hepatectomy may achieve satisfactory efficacy in treating intrahepatic BD. Nevertheless, other studies have shown that 30% of patients may develop postoperative intrahepatic bile duct stones. Considering that this procedure is a higher-risk surgery compared to bilioenteric anastomosis, its effectiveness and safety in the treatment of type IVa BD introduce greater uncertainty.
This study aims at 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 BDs. 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.
- Conditions
- Choledochal Cyst
- Keywords
- Biliary Dilatation, Cohort Study, Surgical Treatment
- Medical subject headings
- Choledochal Cyst
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 |
|---|---|---|
| Liver Resection Group | This group included patients with type IVa BD who underwent liver resection, extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy | |
| Hepaticojejunostomy Group | This group included patients with type IVa BD who underwent extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 30 or 90 days of surgery
Secondary outcomes (5)
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
Measured: Within 30 or 90 days postoperatively
Malignant transformation rate
The occurrence of malignant transformation associated with bile duct dilatation
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 6 months
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.
Measured: Within 30 or 90 days postoperatively
Reoperation rate
The occurrence of reoperation after surgery
Measured: After 30 or 90 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start14 Jul 2025
- Primary completion14 Jul 2025
- Study completion1 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choledochal CystStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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
- 1,500 participants (estimated)
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
- Investigators
- Shuo Jin, PhD, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036848
- Sponsor's protocol ID
- 24637-0-01
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Surgical Treatment in Type IVa Congenital Biliary Dilation: A Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT07036848
- Acronym / sponsor ID
- 24637-0-01
- Conditions
- Choledochal Cyst
- Keywords
- Biliary Dilatation, Cohort Study, Surgical Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 1 Jul 2035 (estimated)
- First posted
- 25 Jun 2025 (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.
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.
Detailed description
Biliary dilatation (BD) is a common complex benign biliary disease. The incidence rate in Asia is one of every 1000 individuals, and the incidence rate in Europe and America is about one of every 50,000-150,000 individuals. Type IVa BD was the most commonly intrahepatic BD and the second most commonly identifiable cyst type. According to the Todani classification of congenital type IVa represents a combination of intra-and extrahepatic cystic ectasias.
However, there is still significant controversy regarding the surgical treatment approaches for this disease. Current treatment methods mainly include hepaticojejunostomy and hepatectomy. On the one hand, studies suggest that performing hepaticojejunostomy while relieving hilar bile duct stricture is sufficient. Previous research has reported that intrahepatic bile duct cysts may regress after hepaticojejunostomy. However, recent studies have described that type IV-A bile duct (BD) patients may develop long-term complications such as intrahepatic bile duct stones, anastomotic stricture, and cholangitis after hepatojejunostomy, although the specific incidence rates remain unclear. On the other hand, only a few small-series studies have reported that hepatectomy may achieve satisfactory efficacy in treating intrahepatic BD. Nevertheless, other studies have shown that 30% of patients may develop postoperative intrahepatic bile duct stones. Considering that this procedure is a higher-risk surgery compared to bilioenteric anastomosis, its effectiveness and safety in the treatment of type IVa BD introduce greater uncertainty.
This study aims at 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 BDs. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver Resection Group | – | –This group included patients with type IVa BD who underwent liver resection, extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy |
| Hepaticojejunostomy Group | – | –This group included patients with type IVa BD who underwent extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a definitive diagnosis of Todani type IVa biliary dilation in the participating centers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
- Unresolved choledocholithiasis, bile duct stenosis, and Intrahepatic bile duct stones during the procedure.
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
Long-term complication-free survival (LCFS)
Time frame: After 30 or 90 days of surgery
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
5 secondary outcomes
Overall perioperative complication rate
Time frame: Within 30 or 90 days postoperatively
Malignant transformation rate
Time frame: Through study completion, an average of 1 year
Mayo Score
Time frame: Through study completion, an average of 6 months
Severe perioperative complication rate
Time frame: Within 30 or 90 days postoperatively
Reoperation rate
Time frame: After 30 or 90 days of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Shuo Jin, PhD principal investigator
Beijing Tsinghua Changgeng Hospital
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 Choledochal Cyst, 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: looking for participants now, as of the sponsor's last update on 17 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changzhen Yang, MD (+86 18810915262, ycz23@mail.tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term complication-free survival (LCFS) (time frame: After 30 or 90 days of surgery). 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 17 Jul 2025.