Ireland
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Recruiting Not applicable

The Optimal Measurement Time for the New Gallbladder Function Assessment Method

NCT07321431 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-01-07
Last updated
2026-01-08

Condition(s) studied

Gallbladder; Functional Disturbance

Investigational drug(s) / intervention(s)

oral administration of 2 fried eggsoral protein bars + 50ml olive oil

oral administration of 2 fried eggs: First, the intervention of oral administration of 2 fried eggs is carried out. The size of the gallbladder is evaluated by ultrasound examination. The washout period is 1 week. After that, the first intervention process of group B is repeated.

oral protein bars + 50ml olive oil: First, an intervention with oral protein bars + 50ml olive oil is conducted. The size of the gallbladder is evaluated through ultrasound examination. The washout period is 1 week. After that, the first intervention process of Group A is repeated.

Study summary

This is a multicenter, prospective, randomized, double-blind, crossover study involving healthy individuals, aiming to evaluate the stability of oral protein bars + olive oil as a new method for determining gallbladder contraction function and its optimal diagnostic time window.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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 * Other biliary tract diseases and related surgical history * History of acute or chronic pancreatitis * 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

Primary outcome measure(s)

  • Gallbladder Volume — during procedure
    Formula for Ultrasound Measurement of Gallbladder Volume (L × W × D × 0.52). Measurements were taken every 20 minutes starting from 30 minutes after the intervention, with a total of 5 measurements (i.e., the gallbladder volume was measured at 30 minutes, 50 minutes, 70 minutes, 90 minutes, and 110 minutes respectively).
  • Gallbladder contraction rate — during procedure
    Subtract the volume of the gallbladder after intervention from the volume of the gallbladder on an empty stomach, then divide by the volume of the gallbladder on an empty stomach, and finally multiply by A-B/A%. The gallbladder contraction rate was calculated at all the above time points.

Trial sites (5)

FacilityCityRegionStatus
Hepatopancreatobiliary Surgery Institute of Gansu Province Lanzhou Gansu Recruiting
The First Hospital of Qinhuangdao Qinhuangdao Hebei Recruiting
The Jinqiu Hospital of Liaoning Province Shenyang Liaoning Recruiting
People's Hospital of Ningxia Hui Autonomous Region Yinchuan Ningxia Recruiting
Honghui Hospital of Xi'an Jiaotong University Xi’an Shanxi Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07321431 on ClinicalTrials.gov ↗ ← All trials in China