Gallbladder Stone
Conditions
Keywords
Gallstone, Gallbladder Function, Cholecystitis, Ultrasound Examination
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.
Interventions
DRUGFunctional fatty acids
Days 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids
OTHERPlacebo
Days 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids
Sponsors
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double (Investigator, Participant)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Gallbladder Volume | 7 days | Measured by ultrasound (L × W × D × 0.52) |
| 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 |
| Occurrence of Acute Pancreatitis Post-Intervention | 14 days | Pain and Amy \>3times as normal |
| Gallbladder Wall Thickness | 7 days | Measured by ultrasound, accurate to 0.1 mm |
Countries
China
Contacts
Primary ContactWenbo Meng, M.D.
Backup ContactLong Deng, M.D.
Outcome results
None listed