Observing CBD stones in high-risk patients using IDUS during ERCP
Practical Value of IDUS in Patients With High Risk of Recurrence of Common Bile Duct Stones After ERCP Lithotomy
This study is testing if using a special ultrasound during a procedure can help high-risk patients avoid getting bile duct stones again and improve their overall recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Municipal Hospital of Traditional Chinese Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06265311 on ClinicalTrials.gov |
What this trial studies
This study investigates the recurrence of common bile duct (CBD) stones in patients identified as high risk for recurrence. Participants are randomly assigned to receive an IDUS examination or standard care during endoscopic retrograde cholangiopancreatography (ERCP). Key metrics such as operation time, radiation exposure, hospitalization costs, and post-procedure complications are recorded and analyzed. The study aims to determine the effectiveness of IDUS in reducing recurrence rates and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with common bile duct stones who exhibit high recurrence risk factors.
Not a fit: Patients with malignant tumors of the liver, biliary system, or duodenum, or those with a history of gallbladder or bile duct surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients at high risk of CBD stone recurrence.
How similar studies have performed: While similar studies have explored the use of IDUS in biliary procedures, this specific approach in high-risk CBD stone patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Clinical diagnosis of common bile duct stones 2.At least one of the following, diameter of CBD\>1.5cm, or number of calculi\>2, or lithotripsy during ercp Exclusion Criteria: * 1. Clinical diagnosis of liver or biliary malignant tumor. 2. Clinical diagnosis of duodenal malignant tumor 3. Failure or unexpected termination of ERCP 4. Surgery history of gallbladder or bile duct.
Where this trial is running
Shanghai
- Shang General Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Hang Zhao, PhD — Shanghai Municipal Traditional Chinese Medicine Hospital
- Study coordinator: Hang Zhao, PhD
- Email: drzhaohang@163.com
- Phone: 18621186288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.