Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

NCT07407491 | Recruiting Phase 2 DMC

• 1 other identifier: JEP-2024-337
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Acute Cholangitis; Biliary Tract Infection; Biliary Obstruction; Choledocholithiasis; Malignant Biliary Stricture

Keywords

Acute Cholangitis; ERCP; Intraductal antibiotics; Biliary tract infection; Choledocholithiasis

Outcome Measures

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.

  1. 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. 2. 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. 3. 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.

  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

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

• To compare the duration of intravenous antibiotic therapy.

  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.

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

Study Arms (2)

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.

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.

Drug: Distilled water

Interventions

Gentamicin - single dose DRUG

Administration described in arm/group description

Gentamicin arm

Distilled water DRUG

Administration described in arm/group description

Distilled water arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (8)

• 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.

  PMID: 25674457 RESULT

• Blenkharn 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.

  PMID: 4083861 RESULT

• Buyukasik 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.

  PMID: 23997958 RESULT

• Sood 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.

  PMID: 26988206 RESULT

• Kimura 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.

  PMID: 17252293 RESULT

• Wada 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.

  PMID: 17252297 RESULT

• Miura 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.

  PMID: 28941329 RESULT

• Lan 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.

  PMID: 28337833 RESULT

MeSH Terms

Conditions

Cholangitis; Choledocholithiasis

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Azlanudin Azman

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiew Toot Chaw

CONTACT

+60176175253; warrentiew@gmail.com

Azlanudin Azman

CONTACT

+60192817878; drazlan@ppukm.ukm.my

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Care provider and patients are blinded from knowing the group of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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)

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 12, 2026
• Study Start: July 9, 2024
• Primary Completion (Estimated): July 8, 2026
• Study Completion (Estimated): July 8, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

MY (1)