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

Not Applicable

Recruiting

• Conditions: Common Bile Duct Stone; Abdominal Massage
• Interventions: Behavioral: Abdominal massage

• Registration Number: NCT05892458
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-10
• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-05-28
• Status Verified: 2023-06
• Study First Posted: 2023-06-07
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 166

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdominal massage group	Abdominal massage	The researchers demonstrated the key points of abdominal massage to patients through a video and provided a detailed explanation of the technique. Patients were encouraged to repeat and practice the massage technique after the video session. To track patient compliance, patients were required to document the frequency of their daily massages, and a designated individual collected this information via WeChat. Follow-up consultations were conducted at 1 month after enrollment and every 3 months thereafter. Patients were encouraged to contact their doctors at any time if they experienced discomfort during the study period.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Recurrence times of CBDS	up to 2 years	The number of stone recurrences within two years
Recurrence time of CBDS	up to 2 years	The specific time it took for patients to have stone recurrence
Post-ERCP complication	up to 2 years	Adverse events after ERCP, including bleeding, perforation, biliary tract infection, and so on

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China