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

Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy: A Prospective, Multicenter, Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Common Bile Duct Stone; Abdominal Massage
• Intervention / Treatment: Behavioral: Abdominal massage

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanglin Pan, MD; Phone Number: 86-29-84771536; Email: yanglinpan@hotmail.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital of Digestive Diseases
      • Contact: Yanglin Pan, MD; Phone Number: 86-29-84771536; Email: yanglinpan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal massage group; 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.	Behavioral: Abdominal 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.
No Intervention: Control group; The control group did not receive any special intervention and were only followed up at 1 month after inclusion and every 3 months thereafter. Patients in this group were advised to contact their doctors if they experienced discomfort during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent rate of CBDS within two years	Within the two years, CBDS was found again by CT, MRCP, ERCP or biliary surgery	up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• Uchida N, Hamaya S, Tatsuta M, Nakatsu T. Extracorporeal abdominal massage may help prevent recurrent bile duct stones after endoscopic sphincterotomy. Endosc Int Open. 2016 Aug;4(8):E870-3. doi: 10.1055/s-0042-109774. Epub 2016 Aug 9.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 28, 2023
• First Submitted That Met QC Criteria: May 28, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Gallstones
• Other Study ID Numbers: KY-20232093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No