The Optimal Measurement Time for the New Gallbladder Function Assessment Method
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oral administration of 2 fried eggs, oral protein bars + 50ml olive oil.
- Who it may be relevant to
- Registry conditions: Gallbladder; Functional Disturbance. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Optimal Measurement Time for the New Gallbladder Function Assessment Method: A Prospective, Multicenter, Double-Blind, Crossover Trial
Overview
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 supplement 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. - Dietary supplement 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.
Primary outcome measures
- Gallbladder Volume [Time frame: during procedure]
- Gallbladder contraction rate [Time frame: during procedure]
Secondary outcome measures (3)
- Presence of Abdominal [Time frame: 30 days]
- Occurrence of Acute Pancreatitis [Time frame: 30 days]
- Occurrence of Gastrointestinal Bleeding Post-Intervention [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
China · 5 centers
- Hepatopancreatobiliary Surgery Institute of Gansu Province — Lanzhou
- The First Hospital of Qinhuangdao — Qinhuangdao
- The Jinqiu Hospital of Liaoning Province — Shenyang
- People's Hospital of Ningxia Hui Autonomous Region — Yinchuan
- Honghui Hospital of Xi'an Jiaotong University — Xi’an
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. PMID 35910468
- Rehfeld JF. Clinical endocrinology and metabolism. Cholecystokinin. Best Pract Res Clin Endocrinol Metab. 2004 Dec;18(4):569-86. doi: 10.1016/j.beem.2004.07.002. PMID 15533776
Identifiers
NCT: NCT07321431 · GB evaluating