Gallstones Clinical Trial
Official title:
A Randomized, Single-blind, Controlled Trial of Electroacupuncture for the Treatment of Symptomatic Gallstone Diseases
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.
Status | Recruiting |
Enrollment | 132 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Patients aged 18 to 70 years of age who are diagnosed of gallstone diseases with the last observable ultrasonography. 2. Patients with symptoms such as recurrent biliary colic 3. Wait-listed for elective cholecystectomy or being recommended to have cholecystectomy by surgeons. 4. Largest gallstone size of smaller than 0.8cm. Exclusion Criteria: 1. Gallstones with the size that cannot be assessed precisely by ultrasound 2. Any gallstone larger than 0.8cm 3. Poor gallbladder ejection fraction computed from Ultrasound-determined fasting and post-prandial gallbladder volumes 4. Contraindication to MRI 5. Patients contraindicated for ERCP 6. Cardiovascular disease with decompensation (New York Heart Association class III or IV) 7. Pregnancy or breastfeeding 8. Alcoholism 9. Intravenous drug users 10. Needle phobia; 11. Unable to respond consistently in trial-out questions of the questionnaire; 12. Refused to provide written informed consent for joining the study |
Country | Name | City | State |
---|---|---|---|
China | The Chinese University of Hong Kong | Hong Kong | Hksar |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | Food and Health Bureau, Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of gallstones (excretion of gallstones confirm by ultrasound) | Change of ultrasound of baseline and 10th week of gallstones for both treatment group and control group patients. | Baseline and 10th week | |
Secondary | Change of Gastrointestinal Quality of Life instrument (GIQOLI) | The Gastrointestinal Quality of Life Instrument measures the domain based on symptoms related to gastrointestinal tract disorder. GIQLI has four subscales including symptoms, emotions, physical functions, social functions and an item (item 24) related to "troubled by medical treatment". The GIQLI is a 35-item, using a five-point Likert-type scale "from 4 (most desirable option ) to 0 (least desirable option )". The total GIQLI score ranged from 0 to 140, is obtained by adding the score of each answer of the 35 items. Patients with higher scores indicate that patients are with higher QOL. This GIQOLI was validated for gallstone diseases patients. The symptom. GIQOLI will be measured at baseline and 10th week. It measured the quality change of life during the observation period. | Baseline and 10th week | |
Secondary | 132 subjects with Liver function test | 132 subjects with Liver function test to measure the liver function across the trial. Blood sample from the liver function includes the blood test for ALT, AST and ALP. Alaine Transaminase (ALT), Asparate Transaminase (AST) and Alkaline Phosphatase (ALP) are important enzyme to reflect the liver function of the body. The monitoring of the liver function tests are very important that may indicate any potential blockage of biliary tree upon during the expel of the gallstone. Therefore the LTF will be assess on baseline, 5th and 10th week. | Baseline, 5th and 10th week | |
Secondary | Clear common bile duct confirm by MRCP | Number of participants with clearness of ultrasound image. The monitoring of the incidence of common bile duct stone by MRCP to ensure no obstruction of common bile duct in the bilary tree | After 10th week if number of gallstones reduced(confirm by ultrasound) | |
Secondary | Number of cases of Serious Adverse Event reported by any subjects | Number of participants with any adverse event including the admission to A&E or reporting of any complications (i.e. acute cholangitis, pancreatitis or etc) will be recorded during the observation period. | Baseline-10th weeks | |
Secondary | Change of EQ-5D | EuroQol Group - 5 dimensions, EQ-5D, is a utility measure general health on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The utility can use to measure the quality of life adjusted life years for economic evaluation.This will be measured at baseline, 5th week and 10th week. It consists of 5 single-item dimensions including: mobility, self care, usual activities. pain/discomfort, and anxiety/depression. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. It measures the quality change of life during the observation period. |
Baseline, 5th week and 10th week | |
Secondary | Change of EQ VAS | This is a visual analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". Thus the higher marks mean better quality of life, this scale also measures the quality change of life during the observation period. | Baseline, 5th week and 10th week | |
Secondary | Change of SF-6D | Short Form - 6 dimensions, SF-6D is a utility measure general health on two dimensions: physical and mental. The utility can use to measure the quality of life adjusted life years for economic evaluation.The symptoms and Health-related quality of life measured by SF-6D will be measured at baseline, 5th week and 10th week. It measured the quality change of life during the observation period. Detail of SF-6D: The SF-6D uses 11 questions from the SF-36 to define the six domains (physical functioning, role limitation, social functioning, pain, mental health, and vitality). Each domain has between four and six levels. The lower the score the more disability while the higher the score the less disability. Descriptive data from the 6 domains can be used to generate a health-related quality of life profile for the subject, ranging from 0-1, 0 is the worst while 1 is the best.The higher the score, the better the quality of l |
Baseline, 5th week and 10th week |
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