Clinical trial NCT06699030: A Strategy for Gallstone Expulsion Through Dietary Therapy
Official title: A New Strategy for Gallstone Expulsion Through Dietary Therapy: A Prospective, Single-Center, Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gallbladder Stone
Keywords: Gallstone
Gallbladder Function
Cholecystitis
Ultrasound Examination
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of patients with complete expulsion of gallbladder sludge after three days of intervention
timeFrame: 7 days
measure: 2）Number of patients with complete expulsion of gallbladder sludge after six days of intervention
timeFrame: 7 days
Secondary outcomes:
measure: Gallbladder Volume
timeFrame: 7 days
measure: Gallbladder Wall Thickness
timeFrame: 7 days
measure: Serum bilirubin
timeFrame: 7 days
measure: Presence of Abdominal Pain Post-Intervention
timeFrame: 7 days
measure: Occurrence of Acute Pancreatitis Post-Intervention
timeFrame: 14 days
measure: Occurrence of Gastrointestinal Bleeding Post-Intervention
timeFrame: 14 days
measure: Nausea, Vomiting, and Diarrhea Post-Intervention
timeFrame: 14 days
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Long Deng
state: Gansu
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Wenbo Meng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhuang Q, Cheng J, Xia J, Ning M, Wu S, Shen S, Shi Y, Huang D, Dong Z, Wan X. Gypenosides Prevent and Dissolve Cholesterol Gallstones by Modulating the Homeostasis of Cholesterol and Bile Acids. Front Med (Lausanne). 2022 Apr 4;9:818144. doi: 10.3389/fmed.2022.818144. eCollection 2022.
citation: Mulliri A, Menahem B, Alves A, Dupont B. Ursodeoxycholic acid for the prevention of gallstones and subsequent cholecystectomy after bariatric surgery: a meta-analysis of randomized controlled trials. J Gastroenterol. 2022 Aug;57(8):529-539. doi: 10.1007/s00535-022-01886-4. Epub 2022 Jun 15.