A Strategy for Gallstone Expulsion Through Dietary Therapy

NCT06699030 | Recruiting DMC

• 1 other identifier: Gallstone Expulsion
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallbladder Stone

Keywords

Gallstone; Gallbladder Function; Cholecystitis; Ultrasound Examination

Outcome Measures

Primary Outcomes (2)

• 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

  7 days

• 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

  7 days

Secondary Outcomes (7)

• Gallbladder Volume

  7 days

• Gallbladder Wall Thickness

  7 days

• Serum bilirubin

  7 days

• Presence of Abdominal Pain Post-Intervention

  7 days

• Occurrence of Acute Pancreatitis Post-Intervention

  14 days

Study Arms (2)

Functional fatty acids

EXPERIMENTAL

Oral Administration of functional fatty acids

Drug: Functional fatty acids

Placebo

PLACEBO COMPARATOR

Oral Administration of Placebo

Other: Placebo

Interventions

Placebo OTHER

Days 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids

Placebo

Functional fatty acids DRUG

Days 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids

Functional fatty acids

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (1)

Long Deng

Lanzhou, Gansu, 730000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 35445045 BACKGROUND

• 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.

  PMID: 35704084 BACKGROUND

MeSH Terms

Conditions

Cholecystolithiasis; Gallstones; Cholecystitis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenbo Meng, M.D.

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbo Meng, M.D.

CONTACT

13919177177; mengwb@lzu.edu.cn

Long Deng, M.D.

CONTACT

13893192432; ldyy_longdengld@lzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Investigator, Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgery

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 21, 2024
• Study Start: December 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)