A Novel Strategy for Evaluating Gallbladder Contraction Function by Ultrasound

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Completed

Conditions: Gallbladder; Functional Disturbance

Treatments: Diagnostic Test: fried eggs first; Diagnostic Test: protein bar first

Study type: Interventional

Funder types: Other

Identifiers

NCT07039864

Gallbladder Function

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ultrasound assessment identifies people with normal biliary tract structure

Exclusion criteria

• 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
• 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 design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Accept A processing first, then accept B processing, One week interval

Experimental group

Description:

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.

Treatment:

Diagnostic Test: protein bar first

Accept B processing first, then accept A processing, One week interval

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: fried eggs first