Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy

Last updated: June 8, 2023
Sponsor: Air Force Military Medical University, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disorders

Gall Bladder Disorders

Treatment

Abdominal massage

Clinical Study ID

NCT05892458
KY-20232093
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-75;
  • Patients with common bile duct stones recurrence;

Exclusion

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, activegastrointestinal 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.

Study Design

Total Participants: 166
Treatment Group(s): 1
Primary Treatment: Abdominal massage
Phase:
Study Start date:
May 10, 2022
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Xijing Hospital of Digestive Diseases

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

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