An interventional study of Abdominal massage in Common Bile Duct Stone and Abdominal Massage, sponsored by Air Force Military Medical University, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-09.
Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Prevention
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.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 166 is above the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Recurrent rate of CBDS within two years
Within the two years, CBDS was found again by CT, MRCP, ERCP or biliary surgery
Time frame: up to 2 years
Recurrence time of CBDS
The specific time it took for patients to have stone recurrence
Time frame: up to 2 years
Recurrence times of CBDS
The number of stone recurrences within two years
Time frame: up to 2 years
Post-ERCP complication
Adverse events after ERCP, including bleeding, perforation, biliary tract infection, and so on
Time frame: up to 2 years
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