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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| protein bar first | Diagnostic Test | Take protein bar(after one week fried eggs intake) to evaluate the size of the gallbladder with ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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% | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| Occurrence of Acute Pancreatitis Post-Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenbo Meng, M.D. Ph. D. | Hepatopancreatobiliary Surgery Institute of Gansu Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatopancreatobiliary Surgery Institute of Gansu Province | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35910468 | Result | 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. | |
| 1455813 | Result |
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| fried eggs first | Diagnostic Test | Take fried eggs (after one week protein bar intake) to evaluate the size of the gallbladder with ultrasound |
|
Pain and Amy 3 times as normal |
| 7 days |
| Occurrence of Gastrointestinal Bleeding Post-Intervention | Black stool or decrease of hemoglobin | 7 days |
| Nausea, Vomiting, and Diarrhea Post-Intervention | Frequency of Nausea, Vomiting, and Diarrhea Post-Intervention | 7days |
| Deinega 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. |