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Recruiting NCT07407491

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

Phase II Interventional Acute Cholangitis Biliary Tract Infection Biliary Obstruction Choledocholithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gentamicin - single dose, Distilled water.
Who it may be relevant to
Registry conditions: Acute Cholangitis, Biliary Tract Infection, Biliary Obstruction, Choledocholithiasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

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.

Interventions

  • Drug Gentamicin - single dose
    Administration described in arm/group description
  • Drug Distilled water
    Administration described in arm/group description

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • To compare the length of hospital stay [Time frame: From hospital admission through hospital discharge during the index hospitalization (up to approximately 30 days).]
  • 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).]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Malaysia · 1 center
  • Hospital Canselor Tuanku Muhriz UKM — Cheras

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. PMID 25674457
  • 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
  • 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
  • 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
  • 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
  • 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/s005 PMID 17252297
  • 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 PMID 28941329
  • 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

Identifiers

NCT: NCT07407491 · JEP-2024-337

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗