The Optimal Measurement Time for the New Gallbladder Function Assessment Method: A Prospective, Multicenter, Double-Blind, Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Gallbladder Volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The PI, study biostatistician will be masked until database lock.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ultrasound assessment identifies people with normal biliary tract structure.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: oral administration of 2 fried eggs (Dietary Supplement)
protein bars
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.
干预措施: oral protein bars + 50ml olive oil (Dietary Supplement)
结局指标
主要结局
Gallbladder Volume
时间窗: 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
时间窗: 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.
次要结局
- Presence of Abdominal(30 days)
- Occurrence of Acute Pancreatitis(30 days)
- Occurrence of Gastrointestinal Bleeding Post-Intervention(30 days)
研究者
Wenbo Meng
Director of Surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province