drugset / Trial / NCT03087656
Antibiotics to Decrease Post ERCP Cholangitis
RandomizedParallel-groupDouble-blindTreatment
Summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to treat bile duct stones, obstructive jaundice, biliary leaks, and a variety of other conditions. There is active debate whether antibiotics should be given prophylactically for ERCP outside of high risk indications including primary sclerosing cholangitis. In part this is due to a lack of appropriately powered clinical trials with adequate follow up. The aim will be to assess whether prophylactic antibiotics decrease the rate of post ERCP cholangitis as defined by the Revised Tokyo Criterion.
Timeline
- Start
- 2017-03-29
- Primary completion
- 2024-02-23
- Completion
- 2024-02-23
Publications
- Results Sauter G, Grabein B, Huber G, Mannes GA, Ruckdeschel G, Sauerbruch T. Antibiotic prophylaxis of infectious complications with endoscopic retrograde cholangiopancreatography. A randomized controlled study. Endoscopy. 1990 Jul;22(4):164-7. doi: 10.1055/s-2007-1012830.
- Results van den Hazel SJ, Speelman P, Dankert J, Huibregtse K, Tytgat GN, van Leeuwen DJ. Piperacillin to prevent cholangitis after endoscopic retrograde cholangiopancreatography. A randomized, controlled trial. Ann Intern Med. 1996 Sep 15;125(6):442-7. doi: 10.7326/0003-4819-125-6-199609150-00002.
- Results Glomsaker T, Soreide K, Hoff G, Aabakken L, Soreide JA; Norwegian Gastronet ERCP group. Contemporary use of endoscopic retrograde cholangiopancreatography (ERCP): a Norwegian prospective, multicenter study. Scand J Gastroenterol. 2011 Sep;46(9):1144-51. doi: 10.3109/00365521.2011.594085. Epub 2011 Jun 22.
- Results Cotton PB, Garrow DA, Gallagher J, Romagnuolo J. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc. 2009 Jul;70(1):80-8. doi: 10.1016/j.gie.2008.10.039. Epub 2009 Mar 14.
- Results Christensen M, Matzen P, Schulze S, Rosenberg J. Complications of ERCP: a prospective study. Gastrointest Endosc. 2004 Nov;60(5):721-31. doi: 10.1016/s0016-5107(04)02169-8.
- Results Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
- Results Bodger K, Bowering K, Sarkar S, Thompson E, Pearson MG. All-cause mortality after first ERCP in England: clinically guided analysis of hospital episode statistics with linkage to registry of death. Gastrointest Endosc. 2011 Oct;74(4):825-33. doi: 10.1016/j.gie.2011.06.007. Epub 2011 Aug 11.
- Results Bai Y, Gao F, Gao J, Zou DW, Li ZS. Prophylactic antibiotics cannot prevent endoscopic retrograde cholangiopancreatography-induced cholangitis: a meta-analysis. Pancreas. 2009 Mar;38(2):126-30. doi: 10.1097/MPA.0b013e318189fl6d.
- Results ASGE Standards of Practice Committee; Khashab MA, Chithadi KV, Acosta RD, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Faulx AL, Fonkalsrud L, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Cash BD. Antibiotic prophylaxis for GI endoscopy. Gastrointest Endosc. 2015 Jan;81(1):81-9. doi: 10.1016/j.gie.2014.08.008. Epub 2014 Nov 11. No abstract available.
- Results Cotton PB, Connor P, Rawls E, Romagnuolo J. Infection after ERCP, and antibiotic prophylaxis: a sequential quality-improvement approach over 11 years. Gastrointest Endosc. 2008 Mar;67(3):471-5. doi: 10.1016/j.gie.2007.06.065. Epub 2007 Dec 3.
- Results Brand M, Bizos D, O'Farrell P Jr. Antibiotic prophylaxis for patients undergoing elective endoscopic retrograde cholangiopancreatography. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD007345. doi: 10.1002/14651858.CD007345.pub2.
- Results Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Gomi H, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF, Dervenis C, Chan AC, Supe AN, Liau KH, Kim MH, Kim SW; Tokyo Guidelines Revision Committee. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):24-34. doi: 10.1007/s00534-012-0561-3.
- Results Carignan A, Allard C, Pepin J, Cossette B, Nault V, Valiquette L. Risk of Clostridium difficile infection after perioperative antibacterial prophylaxis before and during an outbreak of infection due to a hypervirulent strain. Clin Infect Dis. 2008 Jun 15;46(12):1838-43. doi: 10.1086/588291.
- Results Johannes CB, Ziyadeh N, Seeger JD, Tucker E, Reiter C, Faich G. Incidence of allergic reactions associated with antibacterial use in a large, managed care organisation. Drug Saf. 2007;30(8):705-13. doi: 10.2165/00002018-200730080-00007.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ceftriaxone | Other / unclassified | 1 g | Intravenous |
| Comparator | Levofloxacin | Small molecule | 500 mg | Oral |