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A Clinical Trial of Electro-acupuncture for Treating Gallstone Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891147
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Food and Health Bureau, Hong Kong
Information provided by (Responsible Party):
Wendy Wong, Chinese University of Hong Kong

Brief 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.


Condition or disease Intervention/treatment Phase
Gallstones Other: Electro-acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A two arm pragmatic randomized controlled trial design will be conducted at the Prince of Wales Hospitals. 132 patients diagnosed of symptomatic gallstone diseases are on waiting list for cholecystectomy or being recommended to have cholecystectomy by surgeons will be allocated in either EA group (n = 66); or control group (n=66). Treatment group will be offered 20 sessions of EA in 10 weeks, while the control group will remain in the usual care for solely assessment. Primary outcome is the proportion of patients with total clearance of gallstones after treatment with confirmation by ultrasonography. The secondary outcome is the monitoring the incidence of common bile duct stone by liver function test (LFT) and MRCP.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Single-blind, Controlled Trial of Electroacupuncture for the Treatment of Symptomatic Gallstone Diseases
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electro-acupunture (EA) group

Patients will receive the treatment of electro-acupuncture with acupoints (i) Riyue (GB-24) ; (2) Danshu (B19) ; (3) Ganshu (B18) ; (4) Qimen (LR14) ; (5) Yanglingquan (GB34)

The EA will be conducted by using disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length). The needles are inserted at a depth of 10-30 mm vertically or obliquely into acupoints, on which electrical stimulation with continuous waves with 2 Hz and 100 Hz are delivered for 15 min for each frequency through an electrical acupuncture treatment instrument (Hwarto, SDZ-II). The intensities of stimulation are adjusted to a level at which patients feel most comfortable. Each session lasts for 30 minutes.

Other: Electro-acupuncture
No Intervention: Usual care group
Participants randomized to usual care will continue regular follow up arranged by their visiting physicians in public or private sectors. Current usual care of these patients is limited to symptomatic treatment and dietary advice only during the follow-up session in out-patient clinic until the end of observation period (week 10).



Primary Outcome Measures :
  1. Change of gallstones (excretion of gallstones confirm by ultrasound) [ Time Frame: Baseline and 10th week ]
    Change of ultrasound of baseline and 10th week of gallstones for both treatment group and control group patients.


Secondary Outcome Measures :
  1. Change of Gastrointestinal Quality of Life instrument (GIQOLI) [ Time Frame: Baseline and 10th week ]
    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.

  2. 132 subjects with Liver function test [ Time Frame: Baseline, 5th and 10th week ]
    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.

  3. Clear common bile duct confirm by MRCP [ Time Frame: After 10th week if number of gallstones reduced(confirm by ultrasound) ]
    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

  4. Number of cases of Serious Adverse Event reported by any subjects [ Time Frame: Baseline-10th weeks ]
    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.

  5. Change of EQ-5D [ Time Frame: Baseline, 5th week and 10th week ]

    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.


  6. Change of EQ VAS [ Time Frame: Baseline, 5th week and 10th week ]
    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.

  7. Change of SF-6D [ Time Frame: Baseline, 5th week and 10th week ]

    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




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891147


Contacts
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Contact: Wendy Wong, Dr (852) 39433504 wendy.wong@cuhk.edu.hk
Contact: Wai Ling Lin, Dr (852) 2873 3252 wllin@cuhk.edu.hk

Locations
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China, Hksar
The Chinese University of Hong Kong Recruiting
Hong Kong, Hksar, China, 852
Contact: Wendy Wong, Dr    39433504    wendy.wong@cuhk.edu.hk   
Contact: Wai Ling Lin, Dr    28733252    wllin@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Food and Health Bureau, Hong Kong
Investigators
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Principal Investigator: Wendy Wong, Dr HKIIM, CUHK
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Responsible Party: Wendy Wong, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03891147    
Other Study ID Numbers: HMRF-13141331
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wendy Wong, Chinese University of Hong Kong:
symptomatic gallstone diseases
electro-acupuncture
Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical