A Strategy for Gallstone Expulsion Through Dietary Therapy

Last updated: December 24, 2024
Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Liver Disorders

Treatment

Functional fatty acids

Placebo

Clinical Study ID

NCT06699030
Gallstone Expulsion
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gallbladder sludge-like stones with a maximum stone diameter of less than 2 mm

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Functional fatty acids
Phase:
Study Start date:
December 24, 2024
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • Long Deng

    Lanzhou, Gansu 730000
    China

    Active - Recruiting

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