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NCT06699030 | NOT YET RECRUITING | Gallbladder Stone

A Strategy for Gallstone Expulsion Through Dietary Therapy
Sponsor:

Hepatopancreatobiliary Surgery Institute of Gansu Province

Information provided by (Responsible Party):

wen BOM Eng

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.

Condition or disease

Gallbladder Stone

Intervention/treatment

Functional fatty acids

Placebo

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : QUADRUPLE
Masking Description : Double (Investigator, Participant)
Primary Purpose : TREATMENT
Official Title : A New Strategy for Gallstone Expulsion Through Dietary Therapy: A Prospective, Single-Center, Double-Blind, Randomized Controlled Trial
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2026-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Strategy for Gallstone Expulsion Through Dietary Therapy

Location Details

NCT06699030

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Gansu

long length

Lanzhou, Gansu, China, 730000