Common Bile Duct StoneNCT05892458
Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy
A study testing Abdominal massage in people with Common Bile Duct Stone and Abdominal Massage, run by Air Force Military Medical University, China at 1 site in China.
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%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Common Bile Duct Stone, Abdominal Massage
- What is being tested?
- Abdominal massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2022to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75;
- Patients with common bile duct stones recurrence;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Yanglin Pan, MD, 86-29-84771536, yanglinpan@hotmail.com
About this study
Official title: 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.
- Conditions
- Common Bile Duct Stone, Abdominal Massage
- Being tested
- Abdominal massage
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal massageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal massage group | Experimental | 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. Receives: Behavioral: Abdominal massage |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Recurrent rate of CBDS within two years
Within the two years, CBDS was found again by CT, MRCP, ERCP or biliary surgery
Measured: up to 2 years
Secondary outcomes (3)
Recurrence time of CBDS
The specific time it took for patients to have stone recurrence
Measured: up to 2 years
Recurrence times of CBDS
The number of stone recurrences within two years
Measured: up to 2 years
Post-ERCP complication
Adverse events after ERCP, including bleeding, perforation, biliary tract infection, and so on
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start10 May 2022
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892458
- Sponsor's protocol ID
- KY-20232093
- Status last verified
- Jun 2023
- First submitted
- 28 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27540575
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy: A Prospective, Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05892458
- Acronym / sponsor ID
- KY-20232093
- Conditions
- Common Bile Duct Stone, Abdominal Massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal massage group | Experimental | Behavioral: Abdominal massageThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75;
- Patients with common bile duct stones recurrence;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal massageTo 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. | Behavioural | Abdominal massage group |
Primary outcome
Recurrent rate of CBDS within two years
Time frame: up to 2 years
Within the two years, CBDS was found again by CT, MRCP, ERCP or biliary surgery
3 secondary outcomes
Recurrence time of CBDS
Time frame: up to 2 years
Recurrence times of CBDS
Time frame: up to 2 years
Post-ERCP complication
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 27540575Uchida 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal massage in people with Common Bile Duct Stone and Abdominal Massage, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Pan, MD (86-29-84771536, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent rate of CBDS within two years (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.