Gallbladder; Functional Disturbance
Conditions
Keywords
Gallbladder Contractile Function, Ultrasound Examination, Olive oil, Protein Bar, Optimal time
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENToral 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.
DIETARY_SUPPLEMENToral 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.
Sponsors
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The PI, study biostatistician will be masked until database lock.
Intervention model description
A two-period crossover design will be adopted, in which the two intervention methods will be randomly assigned.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Abdominal | 30 days | 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. |
| Occurrence of Acute Pancreatitis | 30 days | Post-Intervention Pain and Amy 3 times as normal. |
| Occurrence of Gastrointestinal Bleeding Post-Intervention | 30 days | Black stool or decrease of hemoglobin. |
Countries
China
Contacts
Primary ContactWenbo Meng, M.D. Ph. D.
Backup ContactLong Deng, M.D.
Outcome results
None listed