A Clinical Trial of Electro-acupuncture for Treating Gallstone Diseases

NCT03891147 | Unknown

• 1 other identifier: HMRF-13141331
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallstones

Keywords

symptomatic gallstone diseases; electro-acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change of Gastrointestinal Quality of Life instrument (GIQOLI)

  Baseline and 10th week

• 132 subjects with Liver function test

  Baseline, 5th and 10th week

• Clear common bile duct confirm by MRCP

  After 10th week if number of gallstones reduced(confirm by ultrasound)

• Number of cases of Serious Adverse Event reported by any subjects

  Baseline-10th weeks

• Change of EQ-5D

  Baseline, 5th week and 10th week

Study Arms (2)

Electro-acupunture (EA) group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

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).

Interventions

Electro-acupuncture OTHER

Electro-acupunture (EA) group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Pregnancy or breastfeeding
• Alcoholism
• Intravenous drug users
• Needle phobia;
• Unable to respond consistently in trial-out questions of the questionnaire;
• Refused to provide written informed consent for joining the study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Food and Health Bureau, Hong Kong: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hksar, 852, China

RECRUITING

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

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

Study Officials

• Wendy Wong, Dr

  HKIIM, CUHK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Wong, Dr

CONTACT

(852) 39433504; wendy.wong@cuhk.edu.hk

Wai Ling Lin, Dr

CONTACT

(852) 2873 3252; wllin@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: March 26, 2019
• Study Start: June 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

CN (1)