Antibiotics to Decrease Post ERCP Cholangitis

NCT03087656 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: HS-16-00880
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholangitis

Keywords

levofloxacin; Ceftriaxone; Cholangitis; ERCP

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion.

  The primary outcome will be the proportion of patients who develop develop post-ERCP cholangitis as defined by the Revised Tokyo criterion within 1 week of ERCP.

  1 week

Secondary Outcomes (2)

• Days of hospitalization

  1 week

• Proportion of patients who develop adverse events of antibiotics

  1 week

Study Arms (2)

Antibiotic arm

ACTIVE COMPARATOR

The drugs ceftriaxone and levofloxacin will be administered to patients in the antibiotic arm.

Drug: Ceftriaxone; Drug: Levofloxacin

No Antibiotic arm

NO INTERVENTION

No prophylactic antibiotics will be administered.

Interventions

Ceftriaxone DRUG

Intravenous Ceftriaxone will be given during the procedure.

Also known as: Rocephin

Antibiotic arm

Levofloxacin DRUG

Oral Levofloxacin will be given for 3 days after the procedure.

Also known as: Levaquin

Antibiotic arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 90 years undergoing therapeutic ERCP for standard, biliary indications including but not limited to:
• suspected bile duct stones
• malignant and benign biliary obstruction
• bile leaks

You may not qualify if:

• Patients who are incarcerated
• Patients who are not competent to give informed consent
• Patients in whom periprocedural antibiotics are mandatory.
• These include patients with:
• primary sclerosing cholangitis,
• multiple biliary strictures,
• hilar tumors,
• neutropenia (absolute neutrophil count \<500), or
• immunosuppressive therapy.
• Patients who have been diagnosed with cholangitis or are suspected to have another active infection requiring antibiotics (such as an infected fluid collection).
• Patients who have received antibiotics within 7 days.
• Patient who have undergone ERCP within 30 days.
• Patients who undergo multiple ERCP for clinical indication will only be eligible to participate in the study for one procedure.
• Patients who have had prior biliary surgeries.
• Patients in whom bile duct decompression is unsuccessful will be excluded as these patients are at increased risk of cholangitis.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (14)

• 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.

  PMID: 2209498 RESULT

• 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.

  PMID: 8779455 RESULT

• 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.

  PMID: 21692712 RESULT

• 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.

  PMID: 19286178 RESULT

• 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.

  PMID: 15557948 RESULT

• 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.

  PMID: 17509029 RESULT

• 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.

  PMID: 21835401 RESULT

• 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.

  PMID: 19238021 RESULT

• 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.

  PMID: 25442089 RESULT

• 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.

  PMID: 18061594 RESULT

• 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.

  PMID: 20927758 RESULT

• 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.

  PMID: 23307001 RESULT

• 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.

  PMID: 18462108 RESULT

• 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.

  PMID: 17696583 RESULT

MeSH Terms

Conditions

Cholangitis

Interventions

Ceftriaxone; Levofloxacin

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• James Buxbaum

  University of Southern California Health Science Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Buxbaum

CONTACT

323 409 5371; jbuxbaum@usc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: subjects to be randomized into two arms: antibiotic arm and no antibiotic arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Endoscopist/Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 22, 2017
• Study Start: March 29, 2017
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)