The Optimal Measurement Time for the New Gallbladder Function Assessment Method

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Enrolling

Conditions: Gallbladder; Functional Disturbance

Treatments: Dietary Supplement: oral administration of 2 fried eggs; Dietary Supplement: oral protein bars + 50ml olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT07321431

GB evaluating

Details and patient eligibility

About

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.

Full description

This is a multicenter, prospective, randomized, single-blind, crossover study involving healthy individuals. This study will use a crossover trial method to compare oral fried eggs with oral protein bars + olive oil. Gallbladder ultrasound examinations will be performed at different time points to measure gallbladder volume, and the changes in gallbladder contraction rates at different time points under the two interventions will be calculated to determine the optimal time window for assessing gallbladder contraction function. On the other hand, the investigators will verify the stability of oral protein bars plus olive oil as a new method for measuring gallbladder contraction function, evaluate its reliability and reproducibility across different regions, hospitals, and populations, ensure its wide clinical application, and provide stronger support for the diagnosis and treatment of gallbladder-related diseases.

Enrollment: 120 estimated 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
• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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120 participants in 2 patient groups

fried eggs

Experimental group

Description:

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.

Treatment:

Dietary Supplement: oral administration of 2 fried eggs

protein bars

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: oral protein bars + 50ml olive oil