Study Title and Why It Matters
Urgent versus early ERCP in mild-to-moderate acute cholangitis: a randomised controlled trial
Acute cholangitis is a potentially serious infection of the bile ducts, most often caused by a blockage from gallstones or, less commonly, strictures or tumors. When bile cannot drain properly, bacteria can multiply, leading to infection, inflammation, jaundice, fever, abdominal pain, and in severe cases, organ failure or death. A key treatment is endoscopic retrograde cholangiopancreatography, or ERCP, a procedure that uses an endoscope passed through the mouth to reach the bile duct and relieve the blockage, often by removing stones or placing a stent.
For many years, clinicians have debated how quickly ERCP should be performed in patients with mild-to-moderate acute cholangitis. Some guidelines and clinical teams favor very rapid intervention, while others consider ERCP within 24 to 48 hours acceptable when the patient is stable and receiving antibiotics and supportive care. This trial directly compared those two approaches.
Background
ERCP is both a diagnostic and therapeutic procedure. In acute cholangitis, the main goal is to decompress the biliary tree, reduce bacterial load, and control the source of infection. In more severe cases, urgent drainage is clearly important. The uncertainty has been greatest for patients with mild-to-moderate disease, where the balance between faster treatment and procedure-related risk is less clear.
A very early procedure may shorten the time to source control, but it can also be technically harder if the patient is unstable, fasting status is incomplete, staffing is limited, or the biliary obstruction is not straightforward. Delaying a few hours may allow stabilization, antibiotic effect, and better procedural conditions. This study was designed to test whether performing ERCP within 24 hours offers better outcomes than performing it between 24 and 48 hours in this patient group.
Study Design
This was a single-center, open-label, randomized controlled trial. A total of 304 patients with mild-to-moderate acute cholangitis were enrolled and randomly assigned to one of two groups: 152 received urgent ERCP within 24 hours, and 152 received early ERCP within 24 to 48 hours.
The average age of participants was 55.58 years, and 218 were men. The two groups were similar at baseline, which is important because it suggests the comparison was fair and that differences in outcome were likely due to timing rather than underlying patient differences.
The primary outcome was 30-day mortality. Secondary outcomes included organ failure on day 3 and day 30, in-hospital mortality, hospital length of stay, need for repeat intervention, readmission rates, and adverse events related to ERCP.
The investigators calculated the sample size based on the idea that urgent ERCP might be superior, assuming event rates of 8% versus 19% in favor of urgent treatment.
Main Results
The trial found no significant advantage for urgent ERCP within 24 hours compared with ERCP performed within 24 to 48 hours.
For 30-day mortality, the rates were 3.95% in the urgent group and 6.58% in the early group. This difference was not statistically significant. The reported hazard ratio was 0.70, with a 95% confidence interval from 0.25 to 1.93, and the p value was 0.47.
Other outcomes also showed no meaningful differences:
In-hospital mortality: 1.97% versus 3.28%
Organ failure on day 3: 9.2% versus 11.2%
Organ failure on day 30: 11.8% versus 17.1%
Reintervention rates: no significant difference
Readmission rates: no significant difference
Median hospital stay: 6.94 days versus 7.84 days
These findings suggest that, for patients with mild-to-moderate acute cholangitis, moving ERCP earlier than 24 hours does not clearly improve survival, reduce organ failure, or shorten hospitalization compared with performing it within the next 24 to 48 hours.
Safety Findings
One of the most important findings was the difference in procedure-related adverse events. In the unadjusted analysis, post-ERCP adverse events were more common in the urgent group than in the early group: 17.1% versus 9.2%. The relative risk was 2.03, with a 95% confidence interval from 1.02 to 4.07.
This matters because ERCP, while generally safe in experienced hands, is still an invasive procedure and can lead to complications such as pancreatitis, bleeding, perforation, infection, or sedation-related events. A very urgent procedure may be done before the patient has fully stabilized, which could contribute to higher complication rates in some settings.
Clinical Interpretation
The overall message from this trial is practical: for patients with mild-to-moderate acute cholangitis, ERCP should be done promptly, but it does not necessarily have to be done immediately within 24 hours if the patient is otherwise stable and can receive the procedure safely within 24 to 48 hours.
This does not mean ERCP can be delayed indiscriminately. Cholangitis is still a medical emergency, and biliary drainage should not be postponed beyond a reasonable window. Patients with severe disease, hemodynamic instability, altered mental status, worsening organ dysfunction, or failure to respond to antibiotics may still require more urgent intervention. The results apply specifically to the mild-to-moderate population studied here.
The findings also highlight an important principle in emergency gastroenterology: faster is not always better if the difference is only a matter of hours and the earlier procedure may occur under less favorable conditions. Good supportive care, antibiotics, monitoring, and timely drainage remain the cornerstones of treatment.
How This Fits With Current Practice
In real-world hospital workflows, arranging ERCP can depend on the availability of endoscopists, anesthesia support, operating rooms or procedure suites, and imaging resources. This trial provides reassurance that, in stable mild-to-moderate cases, a short delay to organize the procedure safely may be acceptable.
For clinicians, this can help with triage and scheduling. For patients and families, it may reduce anxiety when a procedure cannot be done immediately. However, the clinical team must continue to watch for deterioration, because worsening fever, jaundice, hypotension, confusion, rising bilirubin, or organ dysfunction would change the urgency.
Limitations to Consider
As with any trial, there are limitations. This was a single-center study, so the results may not apply equally to all hospitals, healthcare systems, or patient populations. The study was open-label, meaning both clinicians and patients knew the assigned timing, which can sometimes influence care decisions or reporting. In addition, the population was limited to mild-to-moderate disease, so the findings should not be extended to severe acute cholangitis.
The higher rate of adverse events in the urgent group was noted in the unadjusted analysis, and the exact reasons may vary by procedure complexity, operator conditions, or patient factors. More multicenter studies would help confirm whether these findings are consistent across different settings.
Bottom Line
For patients with mild-to-moderate acute cholangitis, urgent ERCP within 24 hours was not superior to early ERCP within 24 to 48 hours for reducing mortality or organ failure. It was associated with a higher rate of procedure-related adverse events in this study.
The practical takeaway is that timely biliary drainage remains essential, but in stable patients with mild-to-moderate disease, ERCP performed within 24 to 48 hours appears to be a reasonable and safe approach.
Trial Registration
ClinicalTrials.gov identifier: NCT05920954
Citation
Jagtap N, Rughwani H, Talukdar R, Chavan D, Memon SF, Asif S, Kulkarni AV, Kalapala R, Ramchandani M, Lakhtakia S, Darisetty S, Venkat Rao G, Tandan M, Bruno MJ, Reddy ND. Urgent versus early ERCP in mild-to-moderate acute cholangitis: a randomised controlled trial. Gut. 2026-05-20. PMID: 42161575.