Cholelithiasis
Conditions
Interventions
Treatment group:Ultrasound-assisted dissolution group
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Adults aged 18-75 years, regardless of sex; 2. Diagnosis of gallbladder stones confirmed by imaging examinations. Stone type is predicted ascholesterol stones or mixed stones (cholesterol content 70%) based on a preoperative multimodalimaging model; maximum stone diameter 0.5-2.0 cm, and number of stones <3; 3. Presence of gallstone-related clinical symptoms (e.g., biliary colic, upper abdominal discomfort,bloating), or asymptomatic patients who strongly request gallbladder preservation and refusecholecystectomy; 4. Preserved gallbladder function, defined as gallbladder ejection fraction 230% on ultrasound, galbladderwall thickness <3 mm, and no significant inflammation, adhesion, or anatomical abnormalities; 5. Generally normal laboratory findings, including liver and renal function, coagulation profile, andcomplete blood count, with no contraindications to the procedure; 6. Ability to comply with treatment and complete a 6-month follow-up, with good adherence; 7. Voluntary provision of writen informed consent and agreement to participate in the study and relateddata collection and analysis.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Pigment stones or calcified stones (predicted cholesterol content 2.0 cm, number >3, or stones impacted in the gallbladder neck that are notamenable to cholangioscopic intervention; 2. Acute cholecystitis, acute exacerbation of chronic cholecystitis, gallbladder perforation or gangrene, orconcomitant common bile duct stones, biliary stricture, biliary tumors, or pancreatic diseases; 3. Impaired gallbladder function, defined as gallbladder ejection fraction 3 mm, or presence of gallbladder atrophy or adenomyomatosis; 4. History of percutaneous gallbladder drainage or gallbladder surgery, or anatomical abnormalities of theduodenal papilla, or contraindications to endoscopic procedures (e.g., severe esophagogastric varices,high risk of gastrointestinal perforation, severe cardiopulmonary dysfunction); 5. Known allergy to the study dissolution agents, or intolerance to ultrasound therapy; 6. Pregnant or lactating women, or patients with severe hepatic or renal dysfunction, coagulationdisorders, immunodeficiency, or malignancy; 7. Participation in other clinical studies, or inability to comply with follow-up or poor adherence that mayaffect the evaluation of study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stone clearance rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of treatment sessions;Gallbladder function;Stone recurrence rate; | — |
Countries
China
Contacts
Public ContactMingyang Li
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed