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Intraductal Antibiotic During ERCP for Acute Cholangitis Treatment

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Study Aim

This phase 2 study aims to evaluate the effectiveness of local intraductal antibiotic administration during ERCP in treating acute cholangitis, by observing the resolution of clinical symptoms, improvement in inflammatory markers, and enhancement in liver function tests.

What is being tested

Gentamicin - single dose

+ Distilled water

Drug
Who is being recruted

Bile Duct Diseases+4

+ Biliary Tract Diseases

+ Cholangitis

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorNational University of Malaysia
Study ContactTiew Toot ChawMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 9, 2024

Actual date on which the first participant was enrolled.

Acute cholangitis is a severe infection in the biliary system, the network of ducts that carry bile from the liver to the gut. It's caused by blocked bile ducts and infected bile, and can quickly lead to a serious condition called sepsis if not treated promptly. The standard treatment involves systemic antibiotics and urgent biliary drainage, often through a procedure called endoscopic retrograde cholangiopancreatography (ERCP). However, the blockage might prevent the antibiotics from reaching the infection site effectively. This study aims to evaluate if delivering antibiotics directly into the bile ducts during ERCP, in addition to standard antibiotic therapy, can improve treatment outcomes in patients with acute cholangitis. During the study, participants will receive antibiotics both systemically and directly into the bile ducts during the ERCP procedure. The study then measures the effectiveness of this approach by monitoring changes in inflammatory markers, liver function tests, and vital signs. Inflammatory markers include total white cell count and C-reactive protein, while liver function tests assess various parameters such as bilirubin levels and enzyme activity. Vital signs like body temperature, blood pressure, and pulse rate are also monitored. These measurements are taken before the ERCP procedure and then 24-72 hours after the procedure to evaluate the treatment's impact.

Official TitleComparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial
Principal SponsorNational University of Malaysia
Study ContactTiew Toot ChawMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

172 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bile Duct DiseasesBiliary Tract DiseasesCholangitisCholelithiasisCommon Bile Duct DiseasesDigestive System DiseasesCholedocholithiasis

Criteria

3 inclusion criteria required to participate
Planned for ERCP within 48 hours

The patients diagnosed with mild and moderate acute cholangitis based on TG 18

18 years old and above

6 exclusion criteria prevent from participating
History of antibiotic hypersensitivity

Recent biliary interventions such as percutaneous transhepatic biliary drainage (PTBD) within last 3 months

Known or suspected perforated tympanic membrane, myasthenia gravis

Receiving cancer chemotherapy, steroids, or immunosuppressive agents

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group receive a single dose of Gentamicin, a type of antibiotic, during their ERCP procedure. This is given to help clear out any remaining material in the bile duct.

Group II

Active Comparator
Patients in this group receive distilled water during their ERCP procedure. This is part of the usual process to clean out the bile duct.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hospital Canselor Tuanku Muhriz UKM

Cheras, MalaysiaOpen Hospital Canselor Tuanku Muhriz UKM in Google Maps
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One Study Center
Intraductal Antibiotic During ERCP for Acute Cholangitis Treatment | PatLynk