Gallbladder; Functional DisturbanceNCT07039864
A Novel Strategy for Evaluating Gallbladder Contraction Function by Ultrasound
A study testing protein bar first and fried eggs first in people with Gallbladder; Functional Disturbance, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
This study is a prospective, single-center, single-blind, cross-over trial conducted at a tertiary hospital, aiming to determine the evaluation of oral functional fatty acids on gallbladder contractile function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gallbladder; Functional Disturbance
- What is being tested?
- protein bar first and fried eggs first
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2025to 20 Dec 2025
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ultrasound assessment identifies people with normal biliary tract structure
Who cannot join
- History of Endoscopic Retrograde Cholangiopancreatography
- Previous gallstone removal surgery with gallbladder preservation
- History of acute or chronic pancreatitis, cholangitis
- Mirizzi Syndrome
- History of gastrointestinal surgery
- Gastrointestinal obstruction
Show all 22Show fewer
- Dysfunction of the sphincter of Oddi
- Gallbladder neck polyps
- Abnormal gallbladder structure
- Gallbladder mass
- Biliary infection or stones
- Congenital biliary abnormalities
- Biliary injury or surgery
- Biliary tumors
- Gastrointestinal bleeding, liver cirrhosis, or other malignant diseases
- Significant arrhythmia, bradycardia, or atrioventricular block
- Severe hypertension, liver or kidney insufficiency
- Immune, endocrine, hematological, or mental disorders
- Severe cerebrovascular disease
- Allergy to relevant foods
- Pregnant or breastfeeding women
- Unwillingness or inability to consent to participation
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
About this study
Official title: A Novel Strategy for Evaluating Gallbladder Contraction Function by Ultrasound: A Prospective, Single-Center, Single-Blind, Cross-Over Trial
This study is a prospective, single-center, single-blind, cross-over trial conducted at a tertiary hospital, aiming to determine the evaluation of oral functional fatty acids on gallbladder contractile function.
Read the detailed description
The most commonly used methods for assessing gallbladder emptying function are radionuclide imaging and ultrasonography. Radionuclide imaging, although effective, has several limitations including lengthy examination time, relatively high costs, and reliance on radioactive isotopes, which has led to its gradual replacement by ultrasonography in clinical practice. Ultrasonography offers significant advantages as a non-invasive modality, providing highly accurate functional evaluations through quantitative analysis. This method objectively reflects gallbladder contraction and emptying capabilities with minimal human interference and demonstrates high reproducibility. Assessment of gallbladder contractile function requires the patient to perform an ultrasound examination on an empty stomach to measure the length, transverse and anterior and posterior diameters of the gallbladder, thus calculating the volume of the fasting gallbladder. The patient is then given a fat meal (usually 2 fried eggs), and the ultrasound examination is performed again 60 minutes after eating to measure the volume of the gallbladder. Gallbladder contractile function is assessed by comparing changes in gallbladder volume on an empty stomach and after a meal. Under normal circumstances, the contraction rate of the gallbladder should reach a certain level. It is generally considered normal to have a contraction rate greater than 30% -50%. However, eating a fat meal, because the fat content of the food itself cannot be accurately determined, will bring inaccurate factors to the evaluation of gallbladder contractile function, such as eating fried eggs, because the variety, size, and quantity of eggs are different, the cooking oil used is different, and the amount of cooking oil remaining on the fried eggs is also different resulting in a large difference in the content of fat in the human body when orally ingested, ultimately leading to an inaccurate evaluation of gallbladder contractile function. Notably, cholesterol in fried eggs may intensify clinical manifestations of cholecystitis, thus necessitating caution when recommending fried eggs to patients with active gallbladder inflammation. Therefore, a prospective, single-center, single-blind, cross-over trial was conducted to verify whether oral functional fatty acids can be used to effectively evaluate gallbladder contractile function.
- Conditions
- Gallbladder; Functional Disturbance
- Being tested
- protein bar first, fried eggs first
- Keywords
- Gallbladder, Function, Ultrasound, Fatty Acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein bar firstDiagnostic test
Take protein bar(after one week fried eggs intake) to evaluate the size of the gallbladder with ultrasound
fried eggs firstDiagnostic test
Take fried eggs (after one week protein bar intake) to evaluate the size of the gallbladder with ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Accept A processing first, then accept B processing, One week interval | Experimental | A processing: Fasting gallbladder ultrasound in the morning and measure the size of the gallbladder. Immediately take one protein bar orally, and then take 50 milliliters of functional fatty acids orally. Review the gallbladder ultrasound and measure the size of the gallbladder at 1 hour and 1.5 hours. Receives: Diagnostic Test: protein bar first |
| Accept B processing first, then accept A processing, One week interval | Active comparator | B processing: Fasting gallbladder ultrasound in the morning and measure the size of the gallbladder. Immediately ingest two fried eggs orally. Review the gallbladder ultrasound and measure the size of the gallbladder at 1 hour and 1.5 hours. Receives: Diagnostic Test: fried eggs first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gallbladder Volume
Ultrasound will be used to measure the volume of the gallbladder on the empty stomach and after the intervention. Formula for Ultrasound Measurement of Gallbladder Volume (L × W × D × 0.52)
Measured: 1 day
Gallbladder contraction rate
The volume of the gallbladder on an empty stomach minus the volume of the gallbladder after the intervention, divided by the volume of the gallbladder on an empty stomach, and finally multiplied by 100%（A-B/A%） Gallbladder contraction rate after 1 hour of oral administration of functional fatty acids with Complete gallbladder emptying100% or Good gallbladder contractility50% or Abnormal gallbladder contractility0%
Measured: 1 day
Secondary outcomes (4)
Presence of Abdominal Pain Post-Intervention
If abdominal pain is present, it will be assessed using the Numerical Rating Scale (NRS) within 0-10, The higher the score, the more serious it is
Measured: 7 days
Occurrence of Acute Pancreatitis Post-Intervention
Pain and Amy 3 times as normal
Measured: 7 days
Occurrence of Gastrointestinal Bleeding Post-Intervention
Black stool or decrease of hemoglobin
Measured: 7 days
Nausea, Vomiting, and Diarrhea Post-Intervention
Frequency of Nausea, Vomiting, and Diarrhea Post-Intervention
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start26 Jun 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gallbladder; Functional DisturbanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, M.D. Ph. D., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039864
- Sponsor's protocol ID
- Gallbladder Function
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ai XN, Wang TF, Zhang Q, Ouyang CG, Wu ZY. Changes in Gallbladder Contractile Function and its Influencing Factors After Minimally Invasive Gallbladder-Preserving Surgery for Cholecystitis With Incarcerated Gallstones. Front Surg. 2022 Jul 14;9:926141. doi: 10.3389/fsurg.2022.926141. eCollection 2022.
PubMed 35910468Deinega VG, Medvedev VV, Polishchuk LM. [The evaluation of gallbladder contractile function and the ultrasonic signs of chronic noncalculous cholecystitis]. Lik Sprava. 1992 Jun;(6):103-6. Russian.
PubMed 1455813
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Strategy for Evaluating Gallbladder Contraction Function by Ultrasound: A Prospective, Single-Center, Single-Blind, Cross-Over Trial
- ClinicalTrials.gov ID
- NCT07039864
- Acronym / sponsor ID
- Gallbladder Function
- Conditions
- Gallbladder; Functional Disturbance
- Keywords
- Gallbladder, Function, Ultrasound, Fatty Acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 26 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 prospective, single-center, single-blind, cross-over trial conducted at a tertiary hospital, aiming to determine the evaluation of oral functional fatty acids on gallbladder contractile function.
Detailed description
The most commonly used methods for assessing gallbladder emptying function are radionuclide imaging and ultrasonography. Radionuclide imaging, although effective, has several limitations including lengthy examination time, relatively high costs, and reliance on radioactive isotopes, which has led to its gradual replacement by ultrasonography in clinical practice. Ultrasonography offers significant advantages as a non-invasive modality, providing highly accurate functional evaluations through quantitative analysis. This method objectively reflects gallbladder contraction and emptying capabilities with minimal human interference and demonstrates high reproducibility. Assessment of gallbladder contractile function requires the patient to perform an ultrasound examination on an empty stomach to measure the length, transverse and anterior and posterior diameters of the gallbladder, thus calculating the volume of the fasting gallbladder. The patient is then given a fat meal (usually 2 fried eggs), and the ultrasound examination is performed again 60 minutes after eating to measure the volume of the gallbladder. Gallbladder contractile function is assessed by comparing changes in gallbladder volume on an empty stomach and after a meal. Under normal circumstances, the contraction rate of the gallbladder should reach a certain level. It is generally considered normal to have a contraction rate greater than 30% -50%. However, eating a fat meal, because the fat content of the food itself cannot be accurately determined, will bring inaccurate factors to the evaluation of gallbladder contractile function, such as eating fried eggs, because the variety, size, and quantity of eggs are different, the cooking oil used is different, and the amount of cooking oil remaining on the fried eggs is also different resulting in a large difference in the content of fat in the human body when orally ingested, ultimately leading to an inaccurate evaluation of gallbladder contractile function. Notably, cholesterol in fried eggs may intensify clinical manifestations of cholecystitis, thus necessitating caution when recommending fried eggs to patients with active gallbladder inflammation. Therefore, a prospective, single-center, single-blind, cross-over trial was conducted to verify whether oral functional fatty acids can be used to effectively evaluate gallbladder contractile function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accept A processing first, then accept B processing, One week interval | Experimental | Diagnostic Test: protein bar firstA processing: Fasting gallbladder ultrasound in the morning and measure the size of the gallbladder. Immediately take one protein bar orally, and then take 50 milliliters of functional fatty acids orally. Review the gallbladder ultrasound and measure the size of the gallbladder at 1 hour and 1.5 hours. |
| Accept B processing first, then accept A processing, One week interval | Active comparator | Diagnostic Test: fried eggs firstB processing: Fasting gallbladder ultrasound in the morning and measure the size of the gallbladder. Immediately ingest two fried eggs orally. Review the gallbladder ultrasound and measure the size of the gallbladder at 1 hour and 1.5 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ultrasound assessment identifies people with normal biliary tract structure
Key exclusion criteria (22 listed)
- History of Endoscopic Retrograde Cholangiopancreatography
- Previous gallstone removal surgery with gallbladder preservation
- History of acute or chronic pancreatitis, cholangitis
- Mirizzi Syndrome
- History of gastrointestinal surgery
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 |
|---|---|---|
| protein bar firstTake protein bar(after one week fried eggs intake) to evaluate the size of the gallbladder with ultrasound | Diagnostic test | Accept A processing first, then accept B processing, One week interval |
| fried eggs firstTake fried eggs (after one week protein bar intake) to evaluate the size of the gallbladder with ultrasound | Diagnostic test | Accept B processing first, then accept A processing, One week interval |
Primary outcome
Gallbladder Volume
Time frame: 1 day
Ultrasound will be used to measure the volume of the gallbladder on the empty stomach and after the intervention. Formula for Ultrasound Measurement of Gallbladder Volume (L × W × D × 0.52)
Gallbladder contraction rate
Time frame: 1 day
The volume of the gallbladder on an empty stomach minus the volume of the gallbladder after the intervention, divided by the volume of the gallbladder on an empty stomach, and finally multiplied by 100%（A-B/A%） Gallbladder contraction rate after 1 hour of oral administration of functional fatty acids with Complete gallbladder emptying100% or Good gallbladder contractility50% or Abnormal gallbladder contractility0%
4 secondary outcomes
Presence of Abdominal Pain Post-Intervention
Time frame: 7 days
Occurrence of Acute Pancreatitis Post-Intervention
Time frame: 7 days
Occurrence of Gastrointestinal Bleeding Post-Intervention
Time frame: 7 days
Nausea, Vomiting, and Diarrhea Post-Intervention
Time frame: 7days
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 26 Dec 2025.
- Results publication: PubMed 35910468Ai XN, Wang TF, Zhang Q, Ouyang CG, Wu ZY. Changes in Gallbladder Contractile Function and its Influencing Factors After Minimally Invasive Gallbladder-Preserving Surgery for Cholecystitis With Incarcerated Gallstones. Front Surg. 2022 Jul 14;9:926141. doi: 10.3389/fsurg.2022.926141. eCollection 2022.
- Results publication: PubMed 1455813Deinega VG, Medvedev VV, Polishchuk LM. [The evaluation of gallbladder contractile function and the ultrasonic signs of chronic noncalculous cholecystitis]. Lik Sprava. 1992 Jun;(6):103-6. Russian.
- 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.
Wenbo Meng, M.D. Ph. D. principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein bar first and fried eggs first in people with Gallbladder; Functional Disturbance, run by Hepatopancreatobiliary Surgery Institute of Gansu Province 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 1 inclusion and 22 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 26 Dec 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?
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?
Gallbladder Volume (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07039864, which also lists 2 linked publications.
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 26 Dec 2025.