Comparing urgent and early ERCP for treating acute cholangitis
Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis
This study is testing whether doing an urgent procedure to treat mild to moderate acute cholangitis within 24 hours is better than doing it between 24 to 48 hours for improving patient outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT05920954 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of urgent endoscopic retrograde cholangiopancreatography (ERCP) performed within 24 hours versus early ERCP conducted between 24 to 48 hours for patients diagnosed with mild to moderate acute cholangitis. The study seeks to determine which timing of the procedure leads to better patient outcomes, including reduced morbidity and mortality. The trial will enroll patients who meet specific criteria for acute cholangitis while excluding those with severe cases or other complicating factors. The findings could provide valuable insights into optimal treatment timing for this serious condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with mild to moderate acute cholangitis who can provide consent.
Not a fit: Patients with severe acute cholangitis, those under 18 years, pregnant women, or individuals with certain complications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for acute cholangitis, potentially reducing complications and mortality rates.
How similar studies have performed: While recent guidelines suggest ERCP within 48 hours, no prior randomized trials have specifically compared urgent versus early ERCP for acute cholangitis, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who met criteria for a definite diagnosis acute cholangitis. Exclusion Criteria: * Patients with severe acute cholangitis at admission. * Age \< 18 years. * Pregnancy. * Associated Acute Severe Pancreatitis. * Patients with suspected high grade (Bismuth III/IV) biliary stricture in whom PTBD is considered as primary method of biliary drainage. * Not giving consent.
Where this trial is running
Hyderabad, Telangana
- AIG Hospitals — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Study coordinator: Hardik Rughwani, MD, DM
- Email: hardik.hr@gmail.com
- Phone: 9426928600
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.