A Strategy for Gallstone Expulsion Through Dietary Therapy

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Enrolling

Conditions: Gallbladder Stone

Treatments: Drug: Functional fatty acids; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06699030

Gallstone Expulsion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Functional fatty acids

Experimental group

Description:

Oral Administration of functional fatty acids

Treatment:

Drug: Functional fatty acids

Placebo

Placebo Comparator group

Description:

Oral Administration of Placebo

Treatment:

Other: Placebo