Incidence of Cholangiocarcinoma on Choledochal CystsQuiCoNCT05404503
Analysis of the Incidence of Cholangiocarcinoma on Choledochal Cyst in a Western Center
An observational study of Incidence of Cholangiocarcinoma on Choledochal Cysts and Postoperative Complications in Choledochal Cysts, run by María Teresa Moreno Asencio at 1 site in Spain.
Trial summary
Choledochal cysts are congenital cystic dilatations of the intra and/or extrahepatic bile duct. They have been considered a rare entity of the child population. Globally, they account for 1% of all biliary pathology benign, with a clearly higher incidence in Asian countries (1/5,000 in China, 1/1,000 in Japan… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incidence of Cholangiocarcinoma on Choledochal Cysts, Postoperative Complications in Choledochal Cysts, Choledochal Cyst Monitoring
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 1 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a radiological diagnosis of choledochal cyst. Those patients diagnosed by the radiology service are included
Who may be able to join
- A radiological diagnosis (diagnosed by the radiology service) of choledochal cyst, understood as a dilatation of the extra or intrahepatic bile duct (fusiform or saccular, following the Todani classification)
Who cannot join
- An objectified obstructive cause that justifies a dilatación of bile duct (lithiasis, papillitis or neoplasia)
- A definitive imaging test that rules out an initial diagnosis of choledochal cyst.
- Intraoperative diagnosis of choledochal cyst without subsequent radiological confirmation.
- Patients with cystic lesions of another nature (biliary cysts, simple cysts, cystic neoplasms).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Choledochal cysts are congenital cystic dilatations of the intra and/or extrahepatic bile duct. They have been considered a rare entity of the child population. Globally, they account for 1% of all biliary pathology benign, with a clearly higher incidence in Asian countries (1/5,000 in China, 1/1,000 in Japan, compared to 1/100,000-150,000 in Western countries). However, the number of adults diagnosed in recent years has increased by up to 70% due to improvements in imaging tests.
Currently, the common bile duct malformation is considered a premalignant entity: although the data are not very precise, it is estimated that between 2.6% and 26% of patients diagnosed choledochal cyst, will develop cholangiocarcinoma. In this sense, we must bear in mind that most of the published literature is of Asian origin, where the rate of cholangiocarcinoma is 0.1-71/100,000 compared to 0.1-1.8/100,000 in Europe or 0.6-1/100,000 in the USA.
Read more
The most used classification to differentiate the types of cysts is that of Todani. Following this classification, we would find a higher rate of malignancy on types I and IV.
The recommendations found in the literature refer to the need for surgical intervention for choledochal cysts due to their high rate of malignancy. These recommendations are based on studies conducted in a symptomatic Asian population. We do not usually find in therapeutic algorithms the inclusion of various factors that could be involved in the development of malignancy such as episodes of cholangitis, presence of anomaly in the pancreatobiliary junction, presence of lithiasis in cystic dilatation, etc.
Some surveys carried out among the scientific population reflect a lack of consensus on its management: in the same clinical situation, different surgery units specialized in hepatobiliary-pancreatic pathology would act in the opposite way (specifically surgical versus conservative treatment).
Bile duct resection is not without complications, both short-term and long-term. Therefore, the patient's symptoms, age or comorbidities can play an important role in decision-making in the treatment of this pathology.
This nationwide multicenter retrospective observational study aims to determine the clinical situation of this rare pathology in a Western environment.
A retrospective analysis of patients diagnosed with choledochal cyst in the period between 2000 and 2020 is proposed. Demographic variables, risk factors for cholangiocarcinoma, symptoms associated with the cyst and its characteristics, diagnostic method, type of treatment, complications will be analyzed. Malignancy, time, and follow-up method will also be discussed.
This study will attempt to answer questions about the incidence of choledochal cysts in our environment, their association with cholangiocarcinoma, the associated morbidity and mortality, as well as the therapeutic and follow-up attitudes adopted in the face of this rare pathology.
- Conditions
- Incidence of Cholangiocarcinoma on Choledochal Cysts, Postoperative Complications in Choledochal Cysts, Choledochal Cyst Monitoring
- Keywords
- cholangiocarcinoma, choledochal cysts, surgery
- Medical subject headings
- Cholangiocarcinoma, Choledochal Cyst
What is being measured
The primary outcome is the main question the study is designed to answer.
Choledochal cyst and cholangiocarcinoma
to analyze the incidence of cholangiocarcinoma in choledochal cysts
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Oct 2022
- Primary completion1 Jan 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of Cholangiocarcinoma on Choledochal CystsStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- María Teresa Moreno Asencio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Teresa Moreno Asencio, Fundación Andaluza Beturia para la Investigación en Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404503
- Sponsor's protocol ID
- MorenoAsencioM
- Acronym
- QuiCo
- Status last verified
- Dec 2025
- First submitted
- 31 May 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Incidence of Cholangiocarcinoma on Choledochal Cyst in a Western Center
- ClinicalTrials.gov ID
- NCT05404503
- Acronym / sponsor ID
- QuiCo / MorenoAsencioM
- Conditions
- Incidence of Cholangiocarcinoma on Choledochal Cysts, Postoperative Complications in Choledochal Cysts, Choledochal Cyst Monitoring
- Keywords
- cholangiocarcinoma, choledochal cysts, surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- María Teresa Moreno AsencioUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Jun 2022 (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.
Choledochal cysts are congenital cystic dilatations of the intra and/or extrahepatic bile duct. They have been considered a rare entity of the child population. Globally, they account for 1% of all biliary pathology benign, with a clearly higher incidence in Asian countries (1/5,000 in China, 1/1,000 in Japan, compared to 1/100,000-150,000 in Western countries). However, the number of adults diagnosed in recent years has increased by up to 70% due to improvements in imaging tests.
Currently, the common bile duct malformation is considered a premalignant entity: although the data are not very precise, it is estimated that between 2.6% and 26% of patients diagnosed choledochal cyst, will develop cholangiocarcinoma. In this sense, we must bear in mind that most of the published literature is of Asian origin, where the rate of cholangiocarcinoma is 0.1-71/100,000 compared to 0.1-1.8/100,000 in Europe or 0.6-1/100,000 in the USA.
The most used classification to differentiate the types of cysts is that of Todani. Following this classification, we would find a higher rate of malignancy on types I and IV.
The recommendations found in the literature refer to the need for surgical intervention for choledochal cysts due to their high rate of malignancy. These recommendations are based on studies conducted in a symptomatic Asian population. We do not usually find in therapeutic algorithms the inclusion of various factors that could be involved in the development of malignancy such as episodes of cholangitis, presence of anomaly in the pancreatobiliary junction, presence of lithiasis in cystic dilatation, etc.
Some surveys carried out among the scientific population reflect a lack of consensus on its management: in the same clinical situation, different surgery units specialized in hepatobiliary-pancreatic pathology would act in the opposite way (specifically surgical versus conservative treatment).
Bile duct resection is not without complications, both short-term and long-term. Therefore, the patient's symptoms, age or comorbidities can play an important role in decision-making in the treatment of this pathology.
This nationwide multicenter retrospective observational study aims to determine the clinical situation of this rare pathology in a Western environment.
A retrospective analysis of patients diagnosed with choledochal cyst in the period between 2000 and 2020 is proposed. Demographic variables, risk factors for cholangiocarcinoma, symptoms associated with the cyst and its characteristics, diagnostic method, type of treatment, complications will be analyzed. Malignancy, time, and follow-up method will also be discussed.
This study will attempt to answer questions about the incidence of choledochal cysts in our environment, their association with cholangiocarcinoma, the associated morbidity and mortality, as well as the therapeutic and follow-up attitudes adopted in the face of this rare pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a radiological diagnosis of choledochal cyst. Those patients diagnosed by the radiology service are included
Key inclusion criteria (1 listed)
- A radiological diagnosis (diagnosed by the radiology service) of choledochal cyst, understood as a dilatation of the extra or intrahepatic bile duct (fusiform or saccular, following the Todani classification)
Key exclusion criteria (4 listed)
- An objectified obstructive cause that justifies a dilatación of bile duct (lithiasis, papillitis or neoplasia)
- A definitive imaging test that rules out an initial diagnosis of choledochal cyst.
- Intraoperative diagnosis of choledochal cyst without subsequent radiological confirmation.
- Patients with cystic lesions of another nature (biliary cysts, simple cysts, cystic neoplasms).
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
Choledochal cyst and cholangiocarcinoma
Time frame: 20 years
to analyze the incidence of cholangiocarcinoma in choledochal cysts
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 6 Jan 2026.
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.
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 Incidence of Cholangiocarcinoma on Choledochal Cysts and Postoperative Complications in Choledochal Cysts, run by María Teresa Moreno Asencio at 1 site in Spain.
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 1 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 6 Jan 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 Spain. 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?
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?
Choledochal cyst and cholangiocarcinoma (time frame: 20 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 6 Jan 2026.