Studies how often bile duct cysts lead to cancer in a Western center
Reviews past records of patients diagnosed with bile duct cysts to track cancer and complications.
Plain-language title generated from the registry record
Registry title: Analysis of the Incidence of Cholangiocarcinoma on Choledochal Cyst in a Western Center
Key facts
- Where
- Huelva, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people diagnosed between 2000 and 2020 with a choledochal cyst, a widening of the bile duct, confirmed by imaging.
- Sex
- All sexes can join.
- Disease stage
- A choledochal cyst (a widening of a bile duct inside or outside the liver, spindle-shaped or sac-shaped, as in the Todani classification), diagnosed by a radiology service.
Main reasons for not taking part
- A clear blockage that explains the widened bile duct (stones, papillitis or tumour)
- A final imaging test that rules out a choledochal cyst
- A cyst found only during surgery, without later confirmation on imaging
- Other kinds of cysts (biliary cysts, simple cysts, cystic tumours)
Read by machine on 9 November 2026.
Where in Spain
- Juan Ramón Jimenez HospitalHuelva, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- María Teresa Moreno Asencio
- Trial code
- NCT05404503
- Record updated
- 6 January 2026
- Original description
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.Read full original descriptionShow less
Analysis of the Incidence of Cholangiocarcinoma on Choledochal Cyst in a Western Center
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.
Inclusion: 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).
Exclusion: 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).