Acute CholangitisPhase 2NCT07407491
Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis
A Phase 2 study testing Gentamicin - single dose and Distilled water in people with Acute Cholangitis and Biliary Tract Infection, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholangitis, Biliary Tract Infection, Biliary Obstruction
- What is being tested?
- Gentamicin - single dose and Distilled water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteMalaysia
- Study dates
- 9 Jul 2024to 8 Jul 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients diagnosed with mild and moderate acute cholangitis based on TG 18
- Planned for ERCP within 48 hours
- 18 years old and above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000
Tiew Toot Chaw, +60176175253, warrentiew@gmail.com
Azlanudin Azman, +60192817878, drazlan@ppukm.ukm.my
About this study
Official title: Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial
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?
Read the detailed description
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.
- Conditions
- Acute Cholangitis, Biliary Tract Infection, Biliary Obstruction, Choledocholithiasis, Malignant Biliary Stricture
- Being tested
- Gentamicin - single dose, Distilled water
- Keywords
- Acute Cholangitis, ERCP, Intraductal antibiotics, Biliary tract infection, Choledocholithiasis
- Medical subject headings
- Cholangitis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentamicin - single doseDrug
Administration described in arm/group description
Distilled waterDrug
Administration described in arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Gentamicin arm | Experimental | In all cases of interventional ERCP, the endoscopist will routinely administer 20cc of distilled water into the bile duct before insertion of the biliary stent or, in cases where a stent is not indicated, before withdrawal of the cannulation catheter from the bile duct to flush out remaining contrast material, sludge, or debris from the bile duct. In this study, the subjects will instead be randomized to receive either 20cc of distilled water as per usual protocol (control arm) or 20cc of intraductal antibiotic (study arm).
Patients will receive intraductal antibiotic Gentamicin 80mg(2ml) diluted in 20cc distilled water during ERCP. Receives: Drug: Gentamicin - single dose |
| Distilled water arm | Active comparator | In all cases of interventional ERCP, the endoscopist will routinely administer 20cc of distilled water into the bile duct before insertion of the biliary stent or, in cases where a stent is not indicated, before withdrawal of the cannulation catheter from the bile duct to flush out remaining contrast material, sludge, or debris from the bile duct. In this study, the subjects will instead be randomized to receive either 20cc of distilled water as per usual protocol (control arm) or 20cc of intraductal antibiotic (study arm).
Patients will receive intraductal distilled water 20cc during ERCP. Receives: Drug: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: Evaluated at specific timepoints at admission, on the day of ERCP (pre-procedure), and daily from Day 1 to Day 3 following ERCP.
Secondary outcomes (3)
To compare the length of hospital stay
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.
Measured: From hospital admission through hospital discharge during the index hospitalization (up to approximately 30 days).
To compare the duration of intravenous antibiotic therapy.
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.
Measured: From initiation of intravenous antibiotic therapy after hospital admission through discontinuation of intravenous antibiotics during the index hospitalization (up to approximately 30 days).
To compare the number of participants that developed a peri-procedural complication.
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.
Measured: Evaluated at specific timepoints during the procedure until day 3 following ERCP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start9 Jul 2024
- Primary completion8 Jul 2026 (estimated)
- Study completion8 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised into the intervention or control group (Intervention group will receive intraductal antibiotic Gentamicin and control group will receive intraductal distilled water in ERCP)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Madya Dr. Azlanudin Azman, National University of Malaysia
- Investigators
- Azlanudin Azman, Principal investigator, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407491
- Sponsor's protocol ID
- JEP-2024-337
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shrayteh ZM, Rahal MK, Malaeb DN. Practice of switch from intravenous to oral antibiotics. Springerplus. 2014 Dec 9;3:717. doi: 10.1186/2193-1801-3-717. eCollection 2014.
PubMed 25674457Blenkharn JI, Habib N, Mok D, John L, McPherson GA, Gibson RN, Blumgart LH, Benjamin IS. Decreased biliary excretion of piperacillin after percutaneous relief of extrahepatic obstructive jaundice. Antimicrob Agents Chemother. 1985 Dec;28(6):778-80. doi: 10.1128/AAC.28.6.778.
PubMed 4083861Buyukasik K, Toros AB, Bektas H, Ari A, Deniz MM. Diagnostic and therapeutic value of ERCP in acute cholangitis. ISRN Gastroenterol. 2013 Aug 13;2013:191729. doi: 10.1155/2013/191729. eCollection 2013.
PubMed 23997958Sood S, Winn T, Ibrahim S, Gobindram A, Arumugam AA, Razali NC, Yasmin P, Hidayu N, Sani H, Mustafa MH, Fatinah A, Devi A, Karim AA, Obaid KJ, Haron NH, Fitjerald H, Koshy M. Natural history of asymptomatic gallstones: differential behaviour in male and female subjects. Med J Malaysia. 2015 Dec;70(6):341-5.
PubMed 26988206Kimura Y, Takada T, Kawarada Y, Nimura Y, Hirata K, Sekimoto M, Yoshida M, Mayumi T, Wada K, Miura F, Yasuda H, Yamashita Y, Nagino M, Hirota M, Tanaka A, Tsuyuguchi T, Strasberg SM, Gadacz TR. Definitions, pathophysiology, and epidemiology of acute cholangitis and cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):15-26. doi: 10.1007/s00534-006-1152-y. Epub 2007 Jan 30.
PubMed 17252293Wada K, Takada T, Kawarada Y, Nimura Y, Miura F, Yoshida M, Mayumi T, Strasberg S, Pitt HA, Gadacz TR, Buchler MW, Belghiti J, de Santibanes E, Gouma DJ, Neuhaus H, Dervenis C, Fan ST, Chen MF, Ker CG, Bornman PC, Hilvano SC, Kim SW, Liau KH, Kim MH. Diagnostic criteria and severity assessment of acute cholangitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):52-8. doi: 10.1007/s00534-006-1156-7. Epub 2007 Jan 30.
PubMed 17252297Miura F, Okamoto K, Takada T, Strasberg SM, Asbun HJ, Pitt HA, Gomi H, Solomkin JS, Schlossberg D, Han HS, Kim MH, Hwang TL, Chen MF, Huang WS, Kiriyama S, Itoi T, Garden OJ, Liau KH, Horiguchi A, Liu KH, Su CH, Gouma DJ, Belli G, Dervenis C, Jagannath P, Chan ACW, Lau WY, Endo I, Suzuki K, Yoon YS, de Santibanes E, Gimenez ME, Jonas E, Singh H, Honda G, Asai K, Mori Y, Wada K, Higuchi R, Watanabe M, Rikiyama T, Sata N, Kano N, Umezawa A, Mukai S, Tokumura H, Hata J, Kozaka K, Iwashita Y, Hibi T, Yokoe M, Kimura T, Kitano S, Inomata M, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: initial management of acute biliary infection and flowchart for acute cholangitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):31-40. doi: 10.1002/jhbp.509. Epub 2018 Jan 8.
PubMed 28941329Lan Cheong Wah D, Christophi C, Muralidharan V. Acute cholangitis: current concepts. ANZ J Surg. 2017 Jul;87(7-8):554-559. doi: 10.1111/ans.13981. Epub 2017 Mar 24.
PubMed 28337833