A Strategy for Gallstone Expulsion Through Dietary Therapy
- Conditions
- Gallbladder Stone
- Interventions
- Drug: Functional fatty acidsOther: Placebo
- Registration Number
- NCT06699030
- Lead Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Functional fatty acids Functional fatty acids Oral Administration of functional fatty acids Placebo Placebo Oral Administration of Placebo
- Primary Outcome Measures
Name Time Method Number of patients with complete expulsion of gallbladder sludge after three days of intervention 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 7 days Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled
- Secondary Outcome Measures
Name Time Method Occurrence of Gastrointestinal Bleeding Post-Intervention 14 days Black stool or decrease of HB
Nausea, Vomiting, and Diarrhea Post-Intervention 14 days Frequency of Nausea, Vomiting, and Diarrhea Post-Intervention
Gallbladder Volume 7 days Measured by ultrasound (L × W × D × 0.52)
Gallbladder Wall Thickness 7 days Measured by ultrasound, accurate to 0.1 mm
Serum bilirubin 7 days Determined by lab examination within 3.4-17.1μmol/L
Presence of Abdominal Pain Post-Intervention 7 days 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 Post-Intervention 14 days Pain and Amy \>3times as normal
Related Research Topics
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Trial Locations
- Locations (1)
Long Deng
🇨🇳Lanzhou, Gansu, China