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

Common Bile Duct Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892458
• Other study ID #: KY-20232093
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: August 2025

Study information

• Verified date: June 2023
• Source: Air Force Military Medical University, China
• Contact: Yanglin Pan, MD
• Phone: 86-29-84771536
• Email: yanglinpan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Massage
• Calculi
• Common Bile Duct Stone
• Gallstones

Intervention

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.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

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