Intraductal Antibiotic During ERCP for Acute Cholangitis Treatment
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.
Gentamicin - single dose
+ Distilled water
Bile Duct Diseases+4
+ Biliary Tract Diseases
+ Cholangitis
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.172 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
Hospital Canselor Tuanku Muhriz UKM
Cheras, MalaysiaOpen Hospital Canselor Tuanku Muhriz UKM in Google Maps