Gallbladder PolypGALPOLNCT06278090
Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution
An observational study of Gallbladder Polyp, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The goal of this observational study is to learn about the impact of ursodeoxycholic acid treatment on the gallbladder polyp evolution in patients with gallbladder polyps that undergo follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Polyp
- What is being tested?
- Ursodeoxycholic Acid Only Product
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients referred for an outpatient consultation to the Departments of Surgery and Gastroenterology due to gallbladder polyps.
Who may be able to join
- Patients with gallbladder polyps eligible for standard follow up (without indication for cholecystectomy or patient decline surgery or polyps < 5mm without risk factors such as age>60 years, primary sclerosing cholangitis, asian ethnicity, sessile polypoid lesion)
Who cannot join
- Patients with gallbladder polyps that received ursodeoxycolic acid doses lower than 10mg/kg/day
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario General de Villalba
Collado Villalba, Madrid, 28400
About this study
Official title: Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution. Prospective Cohort Study
The goal of this observational study is to learn about the impact of ursodeoxycholic acid treatment on the gallbladder polyp evolution in patients with gallbladder polyps that undergo follow up. The main question it aims to answer is:
- Whether ursodeoxycholic acid could decrease the gallbladder polyp size and therefore spare unnecessary follow up or surgical interventions
Read more
Participants will be managed according to the standard practice of the department they are attended:
- According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed Ursodeoxycholic Acid, at 10-15 mg/kg/day for at least 6 months.
- According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.
Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differs significantly.
Read the detailed description
Gallbladder polyps are common findings on abdominal ultrasound studies. Most of them are cholesterol polyps. However, often they require a prolonged follow up due to impossibility to efficiently rule out the presence of a real adenomatous polyps with potential of malignization.
Ursodeoxycholic Acid is a well-studied and long known drug that has been used for conservative treatment of bile stones with high cholesterol concentration (most of them), but also for bile sludge and gallbladder polyps, that are considered precursors of the gallbladder stones. It has been found in several studies that prevent from recurrent idiopathic acute pancreatitis and from gallbladder stone formation after gastric (including bariatric) surgery.
Participants will be managed according to the standard practice of the department they are attended:
- According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed ursodeoxycholic acid, at 10-15 mg/kg/day for at least 6 months.
- According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.
Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differ significantly during the studied period of 1 year. The small size changes could have a great impact on the management of the gallbladder polyps as for a 2mm increase could be a reason to indicate a surgical intervention and a 2mm decrease could cause the discontinuation of the follow up.
- Conditions
- Gallbladder Polyp
- Being tested
- Ursodeoxycholic Acid Only Product
- Keywords
- Gallbladder polyp, Ursodeoxycholic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic Acid Only ProductDrug
Also called Ursobilane, Ursochol
Ursodeoxycholic acid treatment, 10-15mg/kg/day for at least 6 months
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Ursodeoxycholic acid | Patients that recieved prescription for Ursodeoxycholic acid, 10-15 mg/kg for at least 6 months. Receives: Drug: Ursodeoxycholic Acid Only Product | |
| Patients not treated with Ursodeoxycholic acid | Patients without prescription of Ursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing gallbladder polyp size by 2mm or more
Reducing the polyp size by 2mm or more, at the usual ultrasonographic controls at 6 and 12 months.
Measured: 6 and 12 months
Secondary outcomes (1)
Modification of the expected follow up
Depending on the polyp size, physicians could either discontinue the follow up (decreasing to <5mm or disappearing) or indicate surgery (according to the current guidelines). Deviation from the usual evolution of the polyp size, comparing both groups, that leads to alteration of the possible follow up (termination of the follow up when polyp size reduces to <5mm or indication of surgery when polyp size increases by 2mm or reaches 10mm) will be studied.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder PolypStudies 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
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tihomir Georgiev Hristov, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Investigators
- Tihomir Georgiev, MD, PhD, Principal investigator, Hospital Universitario General de Villalba, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278090
- Sponsor's protocol ID
- AUDC
- Acronym
- GALPOL
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution. Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06278090
- Acronym / sponsor ID
- GALPOL / AUDC
- Conditions
- Gallbladder Polyp
- Keywords
- Gallbladder polyp, Ursodeoxycholic acid
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Feb 2024 (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.
The goal of this observational study is to learn about the impact of ursodeoxycholic acid treatment on the gallbladder polyp evolution in patients with gallbladder polyps that undergo follow up. The main question it aims to answer is:
- Whether ursodeoxycholic acid could decrease the gallbladder polyp size and therefore spare unnecessary follow up or surgical interventions
Participants will be managed according to the standard practice of the department they are attended:
- According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed Ursodeoxycholic Acid, at 10-15 mg/kg/day for at least 6 months.
- According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.
Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differs significantly.
Detailed description
Gallbladder polyps are common findings on abdominal ultrasound studies. Most of them are cholesterol polyps. However, often they require a prolonged follow up due to impossibility to efficiently rule out the presence of a real adenomatous polyps with potential of malignization.
Ursodeoxycholic Acid is a well-studied and long known drug that has been used for conservative treatment of bile stones with high cholesterol concentration (most of them), but also for bile sludge and gallbladder polyps, that are considered precursors of the gallbladder stones. It has been found in several studies that prevent from recurrent idiopathic acute pancreatitis and from gallbladder stone formation after gastric (including bariatric) surgery.
Participants will be managed according to the standard practice of the department they are attended:
- According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed ursodeoxycholic acid, at 10-15 mg/kg/day for at least 6 months.
- According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.
Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differ significantly during the studied period of 1 year. The small size changes could have a great impact on the management of the gallbladder polyps as for a 2mm increase could be a reason to indicate a surgical intervention and a 2mm decrease could cause the discontinuation of the follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Ursodeoxycholic acid | – | Drug: Ursodeoxycholic Acid Only ProductPatients that recieved prescription for Ursodeoxycholic acid, 10-15 mg/kg for at least 6 months. |
| Patients not treated with Ursodeoxycholic acid | – | –Patients without prescription of Ursodeoxycholic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred for an outpatient consultation to the Departments of Surgery and Gastroenterology due to gallbladder polyps.
Key inclusion criteria (1 listed)
- Patients with gallbladder polyps eligible for standard follow up (without indication for cholecystectomy or patient decline surgery or polyps < 5mm without risk factors such as age>60 years, primary sclerosing cholangitis, asian ethnicity, sessile polypoid lesion)
Key exclusion criteria (1 listed)
- Patients with gallbladder polyps that received ursodeoxycolic acid doses lower than 10mg/kg/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursodeoxycholic Acid Only ProductAlso: Ursobilane, UrsocholUrsodeoxycholic acid treatment, 10-15mg/kg/day for at least 6 months | Drug | Patients treated with Ursodeoxycholic acid |
Primary outcome
Reducing gallbladder polyp size by 2mm or more
Time frame: 6 and 12 months
Reducing the polyp size by 2mm or more, at the usual ultrasonographic controls at 6 and 12 months.
1 secondary outcome
Modification of the expected follow up
Time frame: 12 months
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 15 Apr 2026.
- 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. This study is not recruiting at the moment.
Tihomir Georgiev, MD, PhD principal investigator
Hospital Universitario General de Villalba, Madrid, Spain
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 Gallbladder Polyp, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz 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 1 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 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?
Reducing gallbladder polyp size by 2mm or more (time frame: 6 and 12 months). 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 15 Apr 2026.