Antibiotic prophylaxis for patients undergoing elective endoscopic retrograde cholangiopancreatography: a survey of South African endoscopists and review of the literature.
Background. Antibiotic prophylaxis for endoscopic retrograde
cholangiopancreatography (ERCP) is controversial. We set out to assess
the current antibiotic prescribing practice among South African
endoscopists who perform ERCPs, and then reviewed international
guidelines and relevant studies.
Methods. Our audit of South African endoscopists who perform ERCPs took the form of a questionnaire. For the literature review a Pubmed search was performed from 1978 to March 2008, and these findings were compared with the current practice in South Africa.
Results. No specific protocols were being implemented widely in South Africa, and there was a marked difference in the practice between surgical and medical gastroenterologists, with surgeons using antibiotics more often. There was also a wide spectrum of antibiotic types that were being used.
The Pubmed search revealed only 7 randomised controlled trials, with little consensus between them as to the absolute indications for prophylactic antibiotics in ERCP.
Conclusions. Guidelines on antibiotic prophylaxis for ERCP are based on poor evidence. Varied opinions on its indications in South Africa may reflect the situation in other countries as well.
|Article Type:||Clinical report|
Antibiotics (Health aspects)
Endoscopic retrograde cholangiopancreatography (Complications and side effects)
Endoscopic retrograde cholangiopancreatography (Usage)
Infection (Risk factors)
|Publication:||Name: South African Journal of Surgery Publisher: South African Medical Association Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2009 South African Medical Association ISSN: 0038-2361|
|Issue:||Date: Feb, 2009 Source Volume: 47 Source Issue: 1|
|Geographic:||Geographic Scope: United States Geographic Code: 1USA United States|
Endoscopic retrograde cholangiopancreatography (ERCP) involves
cannulation of the ampulla of Vater and has diagnostic as well as
therapeutic capabilities, but the number of non-therapeutic ERCPs is
decreasing with time. (1) Endoscopic sphincterotomy, stone extraction
and stenting are not without complications. The most widely recognised
of these include bleeding, which occurs in 0.7 - 2% of patients,
perforation (0.3 - 0.6%), pancreatitis (7%), cholangitis (1%) and
cholecystitis (0.2 - 0.5%). Procedure-related mortality is approximately
0.2%. (2) Review of international guidelines regarding the use of
prophylactic antibiotics with ERCP shows that routine use of
antimicrobials is recommended for biliary obstruction and pancreatic
pseudocysts. However, several studies, including a meta-analysis, fail
to show any benefit. (3-6)
We set out to assess the current antibiotic prescribing practice among South African endoscopists who perform ERCPs, and then review international guidelines and relevant studies.
Our audit of South African endoscopists who perform ERCPs took the form of a questionnaire. This was distributed at the Hepato-Pancreatico-Biliary Association of South Africa Congress held during October 2007 in Johannesburg, and was also sent to all members of the South African Gastro-Enterology Society via email. The questionnaire was anonymous. Endoscopists were questioned regarding their years of experience, the monthly volume of ERCPs they perform, and their indications for antibiotic prophylaxis (for diagnostic biliary ERCP, diagnostic pancreatic ERCP, therapeutic biliary ERCP and therapeutic pancreatic ERCP). Respondents were also asked to indicate their antibiotic of preference and the number of doses administered. The results were then tabulated for comparison, and the chi-squared test was used to calculate p-values. A p-value of 0.05 was considered significant.
A Pubmed search was performed from 1978 to March 2008 using the search terms Cholangiopancreatography-Endoscopic-Retrograde Antibiotic-Prophylaxis, random* or control* or blind* or meta-analys*, all subheadings. An Internet search was also performed to identify recommendations from various international gastrointestinal societies.
Thirty-nine endoscopists (22 surgeons, 16 medical gastro-enterologists and 1 radiologist) responded to our questionnaire. Most had more than 6 years of experience (30/39) and performed more than 10 ERCPs per month (22/39). Approximately half of the endoscopists (19/39) were aware of ERCP antibiotic protocols, either the American Society of Gastro-Enterology (ASGE) or UK National Health Service (NHS) recommendations. The results are depicted in Table I. 'Always' implied that the endoscopist used antibiotic prophylaxis with each patient, 'selected' implied specific indications, and 'never' implied no use of antibiotic prophylaxis.
No endoscopist performed sphincter of Oddi pressure studies. The p-value of surgeons versus other endoscopists using antibiotics for diagnostic biliary ERCP was 0.01, for diagnostic pancreatic ERCP 0.0018, for therapeutic biliary ERCP 0.012 and for therapeutic pancreatic ERCP 0.0014.
The preferred antibiotic was piperacillin and tazobactam (14/39), followed by gentamicin (8/39), cephalosporins (6/39), ciprofloxacin (4/39) and co-amoxiclavulanic acid (3/39). Of the endoscopists 30 administered the antibiotic as a single dose before the procedure, 5 preferred a 24-hour course, 3 gave antibiotics for 48 hours and 1 did so for 5 days. All but 3 of the endoscopists administered the antibiotics via the intravenous route.
The recommendations of various gastrointestinal/endoscopic societies are summarised in Table II.
The Pubmed search yielded 44 results, of which 14 were clinical trials. Of these trials only 2 were randomised, double-blind, placebo-controlled trials (Table III) and 5 were randomised controlled trials (Table IV). Three trials compared different antibiotic regimens and 4 were not applicable to this topic.
Currently there are 102 gastroenterologists registered with the Health Professions Council of South Africa, consisting of 26 surgical and 76 medical gastroenterologists. The 39 doctors who responded to our questionnaire are probably an accurate representation of the endoscopists who perform ERCPs. The results of our questionnaire demonstrate that South African endoscopists do not follow any consistent antibiotic protocol, and that there is also a significant difference in antibiotic usage between surgeons and non-surgeons. It is postulated that surgeons use antibiotics more often because they are more likely to deal with cases of severe pancreatic sepsis and this may influence their prescribing habit. There appears to be no adherence to evidence-based medicine or guidelines in South Africa in this regard. Review of the current literature did not identify a similar national audit of this nature, and we wonder whether the varied antibiotic practice we identified here does not also occur in other countries.
The question arises as to whether or not prophylactic antibiotics are required with ERCP. Experimental studies have shown that bacterial regurgitation from bile into the hepatic venous blood flow, which creates bacteraemia, is directly proportional to biliary pressure, in other words to the degree of obstruction. (11) For this reason decompression alone will effectively either prevent or resolve established cholangitis, although in all likelihood patients with established cholangitis will already be on antibiotics, making prophylactic antibiotics irrelevant. (12) Cotton et al. demonstrated in an 11-year audit of their unit that a high rate of technical success in relieving biliary obstruction reduced the incidence of septic complications as well as the use of prophylactic antibiotics. (13) It is a well-recognised fact that endoscopic procedures result in bacteraemia, and ERCP is associated with a bacteraemia rate as high as 14%. (14) However, studies have shown that organisms isolated on blood or bile cultures and those cultured from the endoscope or the irrigation system are often the same. (6,14,15) Proper disinfection of the endoscope should therefore decrease the frequency of bacteraemia. Routine surveillance cultures of endoscopes should be instituted, but it must be kept in mind that infectious complications can still occur, particularly with Pseudomonas aeruginosa. (16) It has been suggested that even a single confirmed Pseudomonas infection following ERCP should be investigated with an epidemiological study. (17)
Our Pubmed search illustrated the conflicting evidence for the use of prophylactic antibiotics. Van den Hazel et al. (7) and Byl et al. (8) used similar cohorts (patients with an obstructed biliary duct) and came to opposite conclusions. However, the duration of the prophylaxis used in Byl et al.'s study was up to 7 days or until the obstruction was relieved. Only two of the controlled trials concluded that there was a benefit in using prophylaxis in an obstructed biliary system. (9,10) Previously patients at high risk of infective endocarditis, including those with a previous history of infective endocarditis, prosthetic heart valves, cyanotic heart conditions and surgically created shunts or conduits, were thought to require antibiotic cover. (9) However, the current recommendation of the American Heart Association is that antibiotic prophylaxis is not required with any gastrointestinal endoscopic procedure. (18,19) Currently patients who have had a synthetic vascular graft placed within 1 year of the proposed ERCP procedure should receive prophylaxis. (20) Patients who have a prosthetic orthopaedic joint do not require antibiotic prophylaxis. (21)
In our opinion, and after analysis of current literature, the only patients who should receive antibiotic prophylaxis are those who have complex biliary obstruction that is unlikely to be resolved by one ERCP procedure, and probably patients with pancreatic pseudocysts that are not drained. Others are those at high risk of bacterial endocarditis or who have had a synthetic vascular graft within the past year.
Guidelines on antibiotic prophylaxis for ERCP are based on poor evidence, and there is inconsistent usage in South Africa, which may reflect the situation in other countries as well. Overuse seems to be occurring, and we suspect that this is probably the case in other countries. National audits would be helpful in elucidating the magnitude of the problem.
(1.) Romagnuolo J, Cotton PB, Mauldin P, Hawes RH, Lawrence C, Payne KM. Changing trends in ERCP practice over a decade. Gastrointest Endosc 2005; 61: AB155.
(2.) Mallery JS, Baron TH, Dominitz JA, et al. Complications of ERCP. Gastrointest Endosc 2003; 57: 633-638.
(3.) Harris A, Chan AC, Torres-Vierra C, Hammett R, Carr-Locke D. Metaanalysis of antibiotic prophylaxis in endoscopic retrograde cholangiopancreatography (ERCP). Endoscopy 1999; 31: 718-724.
(4.) Llach J, Bordas JM, Almela M, et al. Prospective assessment of the role of antibiotic prophylaxis in ERCP. Hepatogastroenterology 2006; 53: 540-542.
(5.) Lorenz R, Lehn N, Born P, Herrmann M, Neuhaus H. [Antibiotic prophylaxis using cefuroxime in bile duct endoscopy]. Dtsch Med Wochenschr 1996; 121: 223-230.
(6.) 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; 22: 164-167.
(7.) 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; 125: 442-447.
(8.) Byl B, Deviere J, Struelens MJ, et al. Antibiotic prophylaxis for infectious complications after therapeutic endoscopic retrograde cholangiopancreatography: a randomized, double-blind, placebo-controlled study. Clin Infect Dis 1995; 20: 1236-1240.
(9.) Raty S, Sand J, Pulkkinen M, Matikainen M, Nordback I. Post-ERCP pancreatitis: reduction by routine antibiotics. J Gastrointest Surg 2001; 5: 339345; discussion 345.
(10.) Niederau C, Pohlmann U, Lubke H, Thomas L. Prophylactic antibiotic treatment in therapeutic or complicated diagnostic ERCP: results of a randomized controlled clinical study. Gastrointest Endosc 1994; 40: 533-537.
(11.) Lygidakis NJ. The significance of biliary pressure in acute cholangitis. Surg Gynaecol Obstet 1985; 161: 465.
(12.) Somberg KA. Complication of gallstone disease. In: Berk JE, ed. Gastroenterology. Philadelphia: WB Saunders, 1985: 1805-1826.
(13.) 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; 67: 471-475.
(14.) Vennes JA. Infectious complications of gastrointestinal endoscopy. Dig Dis Sci 1981; 60-64.
(15.) Martin TR. The reduction of septic complications following ERCP in obstructed patients. Gastrointest Endosc 1979; 25: 43.
(16.) Fraser TG, Reiner S, Malczynski M, Yarnold PR, Warren J, Noskin GA. Multidrug-resistant Pseudomonas aeruginosa cholangitis after endoscopic retrograde cholangiopancreatography: failure of routine endoscope cultures to prevent an outbreak. Infect Control Hosp Epidemiol 2004; 25: 856-859.
(17.) Classen DC, Jacobson JA, Burke JP, Jacobson JT, Evans RS. Serious Pseudomonas infections associated with endoscopic retrograde cholangiopancreatography. Am J Med 1988; 84: 590-596.
(18.) Dajani AS, Taubert KA, Wilson W, et al. Prevention of bacterial endocarditis. Recommendation by the American Heart Association. Circulation 1997; 96: 358-366.
(19.) Wilson W, Taubert KA, Gewitz M, et al. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. J Am Dent Assoc 2008; 139: Suppl, 3S-24S.
(20.) Malone JM, Moore WS, Campagna G, Bean B. Bacteremic infectability of vascular grafts: the influence of pseudointimal integrity and duration of graft function. Surgery 1975; 78: 211-216.
(21.) American Society of Gastro-Enterology. Guidelines for antibiotic prophylaxis for GI endoscopy. Gastrointest Endoscop 2003; 58: 475-482.
MARTIN BRAND, M.B. CH.B., M.R.C.S
DAMON BIZOS, M.B. B.CH., F.C.S. (S.A.)
Department of Surgery, university of the Witwatersrand, Johannesburg
TABLE I. AUDIT RESULTS Surgeons (N=22) ERCP Always Selected Never Diagnostic biliary 14 5 3 Diagnostic pancreatic 13 6 3 Therapeutic biliary 19 2 1 Therapeutic pancreatic 19 2 1 Gasteroenterologists + radiologist (N=6+1) ERCP Always Selected Never Diagnostic biliary 2 8 5 Diagnostic pancreatic 2 4 11 Therapeutic biliary 5 10 2 Therapeutic pancreatic 5 9 3 'Always' = antibiotic prophylaxis used with each patient; 'selected' = specific indications; 'never'= no use of antibiotic prophylaxis. TABLE II. SUMMARY OF SOCIETY GUIDELINES Society Recommendation Suggested antibiotic ASGE 'All patients undergoing 'Antibiotics that cover ERCP for known or suspected biliary flora such as biliary obstruction or enteric gram-negative known pancreatic organisms, enterococci and pseudocyst should receive possibly pseudomonns are antibiotics along with recommended' adequate drainage of the biliary obstruction or cyst' NHS 'Antibiotic prophylaxis is Oral ciprofloxacin or recommended for all parenteral gentamicin (or patients undergoing ERCP parenteral quinolone, with evidence of biliary cephalosporin or stasis or pancreatic ureidopenicillin) pseudocyst' ESGE 'Antibiotic prophylaxis is Ciprofloxacin 750 mg orally recommended for patients 60-90 min before the who are likely to undergo procedure OR gentamicin 120 therapeutic ERCP if there mg intravenously just has been previous biliary before the procedure OR sepsis, bile duct parenteral quinolone, obstruction or pancreatic cephalosporin or pseudocyst' ureidopenicillin CAG 'Biliary obstruction with Ampicillin 2 g & gentamicin possible sepsis is another 1.5 mg/kg not exceeding 120 high-risk situation, mg intravenously within 30 especially with min of starting; 6 h later, instrumentation, and even ampicillin 1 g average risk patients intravenously or IMI deserve prophylaxis' GESA 'Antibiotic prophylaxis is Ciprofloxacin oral 750 mg recommended for selected or IV 200 mg 2 h before patients' procedure OR Piperacillin 4.5 g IV 30 min before procedure OR piperacillin + tazobactam 4.5 g IV 30 min before procedure OR ticacillin [+ or -] clavulinic acid 3.1 g 30 min before procedure ASGE = American Society of Gastro-Enterology; NHS = UK National Health Services; ESGE = European Society for Gastro-Enterology; CAG = Canadian Association of Gastroenterology; GESA = Gastro-Enterology Society of Australia. TABLE III. RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALS Author Method of study Author's conclusions Van den Group 1: single-dose Single-dose prophylaxis Hazel piperacillin 4 g 30 min with piperacillin is not et before ERCP (N=270) associated with a al. (1) Group II: placebo 30 min clinically significant before ERCP (N=281) reduction in the incidence Inclusion criteria: of acute cholangitis after suspected biliary tract ERCP stones, or distal CBD stricture Byl et Group I: piperacillin 4 g Antimicrobial prophylaxis al. (a) TDS just before ERCP until significantly reduces the biliary obstruction incidence of septic relieved, or maximum of 7 complications days (N=34) Group II: placebo TDS from just before ERCP until obstruction relieved, or maximum of 7 days (N=34) Inclusion criteria: age >18 years, cholestasis, ERCP for ultrasonically suspected bile duct stone/ stricture CBD = common bile duct. TABLE IV. RANDOMISED CONTROLLED TRIALS Author Method of study Author's conclusions Llach et Group I: clindamicin 600 mg Prophylactic administration al. (4) and gentamicin 80 mg 1 h of clindamicin and before ERCP (N=31) gentamicin does not reduce Group II: control (N =30) the incidence of Inclusion criteria: bacteraemia and cholangitis consecutive patients referred for ERCP Lorenz et Group I: single-dose Rates of bacteraemia and al. (5) cefuroxime 1.5 g 30 min septicaemia between two before ERCP (N=49) groups not statistically Group II: control (N=50) significant Inclusion criteria: consecutive patients with bile duct obstruction or pancreatic duct stenosis Raty et Group I: single-dose Antibiotic prophylaxis al. (9) ceftazidime 2 g 30 min effectively decreases the before ERCP risk of pancreatitis and Group II: control cholangitis Inclusion criteria: all consecutive patients for ERCP Niederau Group I: single-dose Prophylactic antibiotics et cefotaxime 2 g 15 min can reduce the incidence of al. (10) before ERCP (N=50) bacteraemia and Group II: control (N=50) septicaemia Inclusion criteria: consecutive patients to undergo therapeutic or complicated diagnostic ERCP Sauter et Group I: single-dose The frequency of al. (6) cefotaxime 2 g 15 min cholangitis following ERCP before ERCP (N=50) was not significantly Group II: control (N=50) reduced by antibiotic Inclusion criteria: prophylaxis unselected consecutive ERCP patients
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