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

Primary Purpose

Common Bile Duct Stone, Abdominal Massage

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Abdominal massage
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Common Bile Duct Stone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing Hospital of Digestive DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Abdominal massage group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recurrent rate of CBDS within two years
Within the two years, CBDS was found again by CT, MRCP, ERCP or biliary surgery

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2023
Last Updated
June 8, 2023
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT05892458
Brief Title
Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy
Official Title
Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy: A Prospective, Multicenter, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Stone, Abdominal Massage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abdominal massage group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Abdominal massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrent rate of CBDS within two years
Description
Within the two years, CBDS was found again by CT, MRCP, ERCP or biliary surgery
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Recurrence time of CBDS
Description
The specific time it took for patients to have stone recurrence
Time Frame
up to 2 years
Title
Recurrence times of CBDS
Description
The number of stone recurrences within two years
Time Frame
up to 2 years
Title
Post-ERCP complication
Description
Adverse events after ERCP, including bleeding, perforation, biliary tract infection, and so on
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanglin Pan, MD
Phone
86-29-84771536
Email
yanglinpan@hotmail.com
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, MD
Phone
86-29-84771536
Email
yanglinpan@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27540575
Citation
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.
Results Reference
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Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy

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