What is this study trying to find out about acute cholangitis?

This study is evaluating whether giving antibiotics directly into the bile duct during ERCP improves treatment outcomes for acute cholangitis compared to standard antibiotic treatment alone. The research aims to see if this method better controls infection and improves recovery. The National University of Malaysia is leading this randomized trial to explore this approach.

Who may be eligible for this acute cholangitis clinical trial?

Adults aged 18 and older diagnosed with mild or moderate acute cholangitis and planned for ERCP within 48 hours may be eligible. People with severe acute cholangitis, recent biliary interventions, or certain medical conditions like immunosuppression are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this acute cholangitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are typically not covered by the study. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07407491

Effectiveness of Adding Intraductal Gentamicin Antibiotic During ERCP for Treating Acute Cholangitis Compared to Standard Treatment

Led by National University of Malaysia · Updated on 2026-02-12

172

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Acute cholangitis is a serious infection of the biliary system caused by blockage and infected bile, which can quickly lead to sepsis if untreated. Researchers are evaluating whether adding intraductal antibiotics during endoscopic retrograde cholangiopancreatography ERCP improves outcomes for patients with acute cholangitis compared to standard systemic antibiotic therapy alone. This study is a phase 2 randomized controlled trial assessing the efficacy and safety of this approach. Participants will undergo ERCP where they are randomly assigned to receive either 20cc of distilled water control or 20cc of intraductal antibiotic Gentamicin 80mg diluted in distilled water study arm during the procedure. In both groups, the endoscopist will flush the bile duct with the assigned solution before placing a biliary stent or removing the catheter. All patients will continue receiving standard systemic antibiotic therapy alongside the study intervention. Throughout the study, participants will be closely monitored for symptom resolution and improvements in inflammatory markers and liver function tests from admission through Day 3 after ERCP. Researchers will also track hospital stay length, duration of intravenous antibiotics, and any complications during and after the procedure. The trial aims to measure the local antibiotics effect on infection control and safety over approximately one month of hospitalization.

CONDITIONS

Brief Title

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosed with mild or moderate acute cholangitis based on TG 18 criteria
Planned for ERCP procedure within 48 hours
Age 18 years or older

You will not qualify if you...

Severe acute cholangitis
History of antibiotic hypersensitivity
Currently receiving cancer chemotherapy, steroids, or immunosuppressive agents
Presence of other infections
Recent biliary interventions such as percutaneous transhepatic biliary drainage within the last 3 months
Known or suspected perforated tympanic membrane or myasthenia gravis

Your Study Journey

Screening

Duration - Up to 2 days before ERCP

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) before ERCP procedure

Treatment

Duration - Single day during ERCP procedure plus monitoring for 3 days after

Participants undergo ERCP where they receive either intraductal antibiotic Gentamicin or distilled water as part of their treatment for acute cholangitis, alongside systemic antibiotics and biliary drainage.

1 treatment visit (in-person) plus daily visits for 3 days following ERCP

Follow-up

Duration - Up to approximately 30 days from hospital admission through discharge

Participants are monitored for resolution of symptoms, improvement in inflammatory markers and liver function tests, and any peri-procedural complications until hospital discharge.

Daily visits during hospitalization up to discharge