A Clinical Trial of Electro-acupuncture for Treating Gallstone Diseases (NCT03891147) | Clinical Trial Compass
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A Clinical Trial of Electro-acupuncture for Treating Gallstone Diseases
China132 participantsStarted 2016-06-01
Plain-language summary
Background: Electro-acupuncture (EA) is commonly used as an alternative treatment for gallstone disease. This study aimed to investigate the effectiveness of EA. If shown effective, patients could preserve their gallbladders from cholecystectomy.
Methods: Within a treatment period of 10 weeks, 132 subjects with symptomatic gallstone diseases (size \<=8mm) were randomly allocated into either treatment group (n=66), or control group (n=66). Treatment group was offered 20 EA sessions while the control group were clinically observed. The primary outcome was the proportion of patients with total/partial clearance of gallstone confirmed by ultrasonography between the two groups. Secondary outcomes were the evaluation of Patients Reported Outcomes (PROs) (e.g.SF6D, GIQLI) collected throughout the treatment period.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Patients aged 18 to 70 years of age who are diagnosed of gallstone diseases with the last observable ultrasonography.
✓. Patients with symptoms such as recurrent biliary colic
✓. Wait-listed for elective cholecystectomy or being recommended to have cholecystectomy by surgeons.
✓. Largest gallstone size of smaller than 0.8cm.
Exclusion criteria
✕. Gallstones with the size that cannot be assessed precisely by ultrasound
✕. Any gallstone larger than 0.8cm
✕. Poor gallbladder ejection fraction computed from Ultrasound-determined fasting and post-prandial gallbladder volumes
✕. Contraindication to MRI
✕. Patients contraindicated for ERCP
✕. Cardiovascular disease with decompensation (New York Heart Association class III or IV)
What they're measuring
1
Change of gallstones (excretion of gallstones confirm by ultrasound)