A Novel Strategy for Evaluating Gallbladder Contraction Function by Ultrasound

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.

Study Overview

• Status: Completed
• Conditions: Gallbladder; Functional Disturbance
• Intervention / Treatment: Diagnostic test: protein bar first; Diagnostic test: fried eggs first

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Hepatopancreatobiliary Surgery Institute of Gansu Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accept A processing first, then accept B processing, One week interval; 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.	Diagnostic test: protein bar first; Take protein bar(after one week fried eggs intake) to evaluate the size of the gallbladder with ultrasound
Active Comparator: Accept B processing first, then accept A processing, One week interval; 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.	Diagnostic test: fried eggs first; Take fried eggs (after one week protein bar intake) to evaluate the size of the gallbladder with ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Principal Investigator: Wenbo Meng, M.D. Ph. D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Actual): December 20, 2025
• Study Completion (Actual): December 20, 2025

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; Function; Gallbladder; Fatty Acids
• Other Study ID Numbers: Gallbladder Function

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No