Abdominal Massage, Common Bile Duct Stone
Conditions
Brief summary
Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are the preferred techniques for treating common bile duct stones (CBDS) due to their advantages of minimal trauma, rapid recovery, low cost, and high success rates of up to 95%. Despite these benefits, the recurrence rate of CBDS in patients after endoscopic therapy ranges from 4% to 25%, posing a significant challenge for endoscopists and an urgent problem to be addressed. Abdominal massage is a promising non-invasive physical intervention for preventing recurrent CBDS. This technique is a simple, effective, and non-invasive technique that can be utilized for patient self-management and is widely used in the field of digestive diseases. External pressure applied to the common bile duct during abdominal massage may promote bile excretion from the duct to the duodenum, similar to the effect of gallbladder movement flushing bile, which can prevent bile deposition in the common bile duct, thereby preventing the formation of new stones or flushing away newly-generated small stones. Therefore, investigators plan to conduct a prospective, multicenter, randomized controlled study to investigate the preventive effect of abdominal massage in patients with recurrent CBDS.
Interventions
BEHAVIORALAbdominal massage
To perform abdominal massage, patients should keep their upper body in an upright or semi-decumbent position. Using their right four fingers or palm, they should apply pressure to the middle point of the lower margin of the right upper abdominal ribs, which corresponds to the opening of the gallbladder and common bile duct. The pressure should be firm, with a depth of approximately 3-4 cm and a length of 5-10 cm, and should be applied at least once a day for 10-15 minutes per session.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75; * Patients with common bile duct stones recurrence;
Exclusion criteria
* Incomplete clearance of recurrent common bile duct stones; * Anatomical changes (such as Billroth I/II, Roux-en-Y); * Contraindications to abdominal massage (such as abdominal surgery, active gastrointestinal bleeding, intestinal obstruction, acute abdomen, etc.); * Expected lifespan of less than two years; * Unstable hemodynamics; * Malignant arrhythmia; * Pregnancy or lactation; * Unwillingness or inability to sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent rate of CBDS within two years | up to 2 years | Within the two years, CBDS was found again by CT, MRCP, ERCP or biliary surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence time of CBDS | up to 2 years | The specific time it took for patients to have stone recurrence |
| Recurrence times of CBDS | up to 2 years | The number of stone recurrences within two years |
| Post-ERCP complication | up to 2 years | Adverse events after ERCP, including bleeding, perforation, biliary tract infection, and so on |
Countries
China
Contacts
Primary ContactYanglin Pan, MD
Outcome results
None listed