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NCT Number: NCT07407491

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

Does intraductal administration of antibiotics during endoscopic retrograde cholangiopancreatography (ERCP), in addition to standard systemic antibiotic therapy, improve clinical outcomes in patients with acute cholangitis compared with standard systemic antibiotic therapy alone?

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

Acute cholangitis is a serious infection of the biliary system caused by biliary obstruction and infected bile, which may rapidly progress to sepsis if not promptly treated. Standard management includes systemic antibiotics and urgent biliary drainage, most commonly by endoscopic retrograde cholangiopancreatography (ERCP). However, biliary obstruction may impair biliary excretion of systemically administered antibiotics, resulting in subtherapeutic antibiotic concentrations within infected bile. Intraductal administration of antibiotics during ERCP may achieve higher local antimicrobial concentrations at the site of infection. This study evaluates the efficacy and safety of intraductal antibiotic administration during ERCP as an adjunct to standard systemic antibiotic therapy in patients with acute cholangitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients diagnosed with mild and moderate acute cholangitis based on TG 18
  • Planned for ERCP within 48 hours
  • 18 years old and above

Exclusion criteria

  • Severe acute cholangitis
  • History of antibiotic hypersensitivity
  • Receiving cancer chemotherapy, steroids, or immunosuppressive agents
  • Concomitant infections
  • Recent biliary interventions such as percutaneous transhepatic biliary drainage (PTBD) within last 3 months
  • Known or suspected perforated tympanic membrane, myasthenia gravis

Treatment and study plan

Gentamicin - single dose

Drug

Administration described in arm/group description

distilled water

Drug

Administration described in arm/group description

Primary outcomes

  1. To evaluate the efficacy of local intraductal antibiotic administration during ERCP in patients with acute cholangitis, as assessed by resolution of clinical symptoms and improvement in inflammatory markers and liver function tests.

    Time frame: Evaluated at specific timepoints at admission, on the day of ERCP (pre-procedure), and daily from Day 1 to Day 3 following ERCP.

    • Change in Inflammatory Markers: Reduction in total white cell count (WCC), expressed in ×10⁹/L, and C-reactive protein (CRP), expressed in mg/L, measured from baseline (pre-ERCP) to 24-72 hours post-ERCP.
    • Change in Liver Function Tests: Improvement in liver function parameters including total bilirubin (µmol/L), direct bilirubin (µmol/L), alkaline phosphatase (ALP; U/L), alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), and international normalized ratio (INR), measured from baseline (pre-ERCP) to 24-72 hours post-ERCP.
    • Change in Vital Signs: Serial improvement in vital signs, including body temperature (°C), blood pressure (mmHg), and pulse rate (beats per minute), measured from baseline (pre-ERCP) to 72 hours following ERCP.

Secondary outcomes

  1. To compare the length of hospital stay

    Time frame: From hospital admission through hospital discharge during the index hospitalization (up to approximately 30 days).

    Total duration of hospitalization, calculated as the number of days from the date of hospital admission to the date of hospital discharge following the index ERCP procedure.

  2. To compare the duration of intravenous antibiotic therapy.

    Time frame: From initiation of intravenous antibiotic therapy after hospital admission through discontinuation of intravenous antibiotics during the index hospitalization (up to approximately 30 days).

    Criteria for intravenous to per oral switch antibiotic:

    • Able to tolerate oral therapy
    • No vomiting or diarrhea or nil by mouth
    • Clinical improvement with temperature less than 38°C, systolic blood pressure >90 mmHg, heart rate <100 beats per minute, and normal white blood cell count or a decrease of at least 2x10^9/L over the last 24 hours.
  3. To compare the number of participants that developed a peri-procedural complication.

    Time frame: Evaluated at specific timepoints during the procedure until day 3 following ERCP.

    Peri-procedural complications assessed by post-ERCP monitoring, including pancreatitis, procedure-related bleeding, cardiopulmonary complications, gastrointestinal perforation, and sedation-related adverse events, recorded until day 3 following ERCP.

Study contacts

Contact information is provided by the study sponsor or research team.

Azlanudin Azman

CONTACT

[email protected]

+60192817878

Tiew Toot Chaw

CONTACT

[email protected]

+60176175253

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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