A New Strategy for Gallstone Expulsion Through Dietary Therapy: A Prospective, Single-Center, Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients with complete expulsion of gallbladder sludge after three days of intervention
研究概览
简要总结
This study is a double-blind, prospective, single-center controlled trial conducted at a tertiary hospital, aiming to determine whether dietary therapy can effectively expel gallstones.
详细描述
Gallstones are a common clinical condition, and their prevalence has been increasing globally in recent years. Gallstone formation is a result of various combined factors, and in its early stages, gallstones often exist in a sludge-like form. Currently, there is no definitive research on whether gallbladder sludge can be effectively expelled through medication or dietary therapy. Therefore, the investigators are conducting a double-blind, prospective, single-center controlled trial to verify whether gallbladder sludge-like stones can be effectively expelled using dietary therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double (Investigator, Participant)
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
- 否
入选标准
- •Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm
排除标准
- •History of ERCP (Endoscopic Retrograde Cholangiopancreatography)
- •Previous gallstone removal surgery with gallbladder preservation
- •History of acute or chronic pancreatitis, cholangitis
- •Mirizzi Syndrome
- •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
Functional fatty acids
Oral Administration of functional fatty acids
干预措施: Functional fatty acids (Drug)
Placebo
Oral Administration of Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of patients with complete expulsion of gallbladder sludge after three days of intervention
时间窗: 7 days
Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled
2）Number of patients with complete expulsion of gallbladder sludge after six days of intervention
时间窗: 7 days
Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled
次要结局
- Gallbladder Volume(7 days)
- Gallbladder Wall Thickness(7 days)
- Serum bilirubin(7 days)
- Presence of Abdominal Pain Post-Intervention(7 days)
- Occurrence of Acute Pancreatitis Post-Intervention(14 days)
- Occurrence of Gastrointestinal Bleeding Post-Intervention(14 days)
- Nausea, Vomiting, and Diarrhea Post-Intervention(14 days)
研究者
Wenbo Meng
Director of Surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province