About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm
Disqualifiers
History of ERCP (Endoscopic Retrograde Cholangiopancreatography)
Previous gallstone removal surgery with gallbladder preservation
History of acute or chronic pancreatitis, cholangitis
Mirizzi Syndrome
Trial design
Parallel
Treatments tested in this trial
Functional fatty acids
DrugDays 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids
Placebo
Other interventionDays 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with complete expulsion of gallbladder sludge after three days of intervention
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
Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled
Secondary outcomes
Gallbladder Volume
Measured by ultrasound (L × W × D × 0.52)
Gallbladder Wall Thickness
Measured by ultrasound, accurate to 0.1 mm
Serum bilirubin
Determined by lab examination within 3.4-17.1μmol/L
Presence of Abdominal Pain Post-Intervention
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
Sponsors and contacts
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