Evaluating single-session endoscopic stone extraction for acute cholangitis
Effectiveness and Safety of Single-session Endoscopic Stone Extraction for Acute Cholangitis Associated With Choledocholithiasis
This study is testing if a one-time procedure to remove stones from the bile duct is as safe and effective as the usual two-step method for people with acute cholangitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06349954 on ClinicalTrials.gov |
What this trial studies
This prospective study involves approximately 64 patients suffering from acute cholangitis due to choledocholithiasis at Beijing Friendship Hospital. Participants will be randomly assigned to receive either single-session or two-session endoscopic stone extraction. The study aims to assess the effectiveness and safety of the single-session approach compared to the traditional two-session method. By evaluating patient outcomes, the research seeks to provide insights into optimizing treatment protocols for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 90 who have been diagnosed with Grade I or II acute cholangitis and confirmed choledocholithiasis.
Not a fit: Patients with severe anatomical changes, previous interventions, or significant comorbidities that prevent them from tolerating endoscopic procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient and less painful treatment option for patients with acute cholangitis and choledocholithiasis.
How similar studies have performed: Previous studies have indicated that single-session endoscopic stone extraction can be safe and effective, although this specific approach is still being evaluated for broader clinical application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Age ≥18 years old and ≤90 years old * 2. Patients met the Tokyo Guidelines 2018 (TG18) diagnosis of Grade I or Grade II acute cholangitis * 3. Imaging examination confirmed the presence of choledocholithiasis Exclusion Criteria: * 1. Common bile duct with benign or malignant stenosis * 2. Changes in the anatomical structure of the stomach or duodenum * 3. Patients with common biliary duct or pancreatic duct stent * 4. Patients complicated with acute pancreatitis * 5. Patients who underwent endoscopic intervention, percutaneous transhepatic cholangio drainage (PTCD) or other invasive interventions before admission * 6. Patients with cardiac failure, respiratory failure or consciousness disorder can not tolerate endoscopic operation * 7. Patients who have coagulation dysfunction or are taking anticoagulation and antiplate drugs * 8. Imaging examination showed that the maximum diameter of choledocholithiasis was more than 1.5cm
Where this trial is running
Beijing, Beijing
- Beijing Friendship Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Fujing Lv, M.D. — Beijing Friendship Hospital
- Study coordinator: Wei Jiang, Ph.D
- Email: jfw899w@outlook.com
- Phone: 18663186116
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.