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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentamicin - single dose | Drug | Administration described in arm/group description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Evaluated at specific timepoints at admission, on the day of ERCP (pre-procedure), and daily from Day 1 to Day 3 following ERCP. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From hospital admission through hospital discharge during the index hospitalization (up to approximately 30 days). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiew Toot Chaw | Contact | +60176175253 | warrentiew@gmail.com | |
| Azlanudin Azman | Contact | +60192817878 | drazlan@ppukm.ukm.my |
| Name | Affiliation | Role |
|---|---|---|
| Azlanudin Azman | Universiti Kebangsaan Malaysia Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Canselor Tuanku Muhriz UKM | Recruiting | Cheras | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25674457 | Result | 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. | |
| 4083861 | 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. |
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| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D003137 | Common Bile Duct Diseases |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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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)
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Care provider and patients are blinded from knowing the group of the study.
| Distilled water |
| Drug |
Administration described in arm/group description |
|
| To compare the duration of intravenous antibiotic therapy. |
Criteria for intravenous to per oral switch antibiotic:
|
| 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. | Evaluated at specific timepoints during the procedure until day 3 following ERCP. |
| 23997958 | 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. |
| 26988206 | 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. |
| 17252293 | 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. |
| 17252297 | 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. |
| 28941329 | 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. |
| 28337833 | 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. |
| D002769 | Cholelithiasis |