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  1. 1. Revista de Gastroenterología de México. 2012;77(3):125-129ORIGINAL ARTICLEEndoscopic retrograde cholangiopancreatography at a regionalhospital of the Instituto Mexicano del Seguro Social, 2002-2011:risk factors and complicationsG. A. Reyes-Moctezumaa,*, L. Sevilla-Suarez-Peredoa,b, M.R. Reyes-Bastidasa, M. A. Ríos-Ayalac, J. E. Rosales-Lealc, I. Osuna-Ramírezda Department of Gastroenterology and Endoscopy, Hospital General Regional No.1, Instituto Mexicano del Seguro Social,Culiacán, Sinaloa, Mexicob Department of Internal Medicine, Universidad Autónoma de Sinaloa, Culiacán, Sinaloa, Mexicoc Social Service, Universidad Autónoma de Sinaloa, Culiacán, Sinaloa, Mexicod Public Health Research Unit, Universidad Autónoma de Sinaloa, Culiacán, Sinaloa, MexicoReceived 15 February 2012; accepted 23 April 2012Available online 24 August 2012 Keywords Abstract Cholangiography; Background: Endoscopic retrograde cholangiopancreatography (ERCP) is a valuable study in the Endoscopy; approach to diseases of the biliary and pancreatic ducts. It was first used for diagnostic purpo- Complications; Risk; ses, but today its use is mainly therapeutic. It can present a variety of complications. Mexico Aims: To determine the frequency of complications and the risk factors associated with ERCP. Methods: A prolective study was carried out to analyze ERCP that was performed on 1.145 pa- tients over a 10-year period (2002-2011). Complications were determined at the time of the procedure, through the personal communication of relatives, and/or when the patient was ad- mitted to the emergency room. Follow-up was carried out for one month after ERCP in the outpatient service of the Department of Gastroenterology. Complications were evaluated with a multiple logistic regression model. Results: The sample included 1.145 patients. Mean age was 55,3 years (SD=18,7; 95% CI: 54,2- 56,3). Women made up 60,5% (n=693) of the study participants. Therapeutic endoscopy was performed in 51,0% of the total number of procedures. Complications presented in 2,1% (n=24) of the patients; the most frequent was hemorrhage (n=14, 1,2%), followed by acute pancreatitis (n=6, 0,5%), respiratory distress (n=3, 0,3%), and cholangitis (n=1, 0,1%). There was a 1,4 times higher complication risk in patients that underwent precut/sphincterotomy, adjusted by age (95% CI: OR 1,02-5,43; p=0,045). Conclusions: This study shows a complication frequency similar to that published by other authors. However, this figure could be further reduced if ERCP were performed only for thera- peutic purposes by highly qualified endoscopy physicians. © 2012 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved. *Corresponding author: Blvrd. Alfonso G. Calderón 2193 pte, Desarrollo Tres Ríos, C.P. 80070, Culiacán, Sinaloa, México. Telephone: (667) 758 7917. Email: remoca@prodigy.net.mx (G.A. Reyes-Moctezuma).0375-0906/$ – see front matter © 2012 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. Todos los derechos reservados.http://dx.doi.org/10.1016/j.rgmx.2012.04.012
  2. 2. 126 G.A. Reyes-Moctezuma et al PALABRAS CLAVE Colangiopancreatografía retrógrada endoscópica en un hospital regional del Instituto Colangiografía; Mexicano del Seguro Social, 2002-2011: factores de riesgo y complicaciones Endoscopía; Complicaciones; Resumen Riesgo; Introducción: La colangiopancreatografía retrógrada endoscópica (CPRE) es un estudio útil en el México abordaje de las enfermedades pancreático-biliares, con fines diagnósticos en sus inicios. Actual- mente, sólo con fines terapéuticos y las complicaciones son variadas. Objetivo: Determinar frecuencia de complicaciones y factores de riesgo asociados a CPRE. Material y métodos: En un periodo de 10 a˜nos (2.002-2.011), 1.145 pacientes fueron sometidos a CPRE. Las complicaciones fueron determinadas al momento del estudio, por comunicación personal de los familiares y/o al acudir al Servicio de Urgencias, el seguimiento se efectuó du- rante un mes después de realizada CPRE en la consulta externa de Gastroenterología. Un mode- lo de regresión logística múltiple fue usado para evaluar complicaciones. Resultados: La muestra quedó constituida por 1.145 pacientes. La edad promedio fue de 55,3 años (DE = 18,7; IC 95%: 54,2-56,3). El 60,5% (n = 693) de los participantes correspondió al gé- nero femenino. La endoscopía terapéutica se efectuó en el 51,0% del total de los estudios rea- lizados. Las complicaciones fueron del 2,1% (n = 24), la más frecuente fue hemorragia (n = 14, 1,2%), seguido por pancreatitis aguda (n = 6, 0,5%), depresión respiratoria (n = 3, 0,3%) y colan- gitis (n = 1, 0,1%). El riesgo de complicación fue de 1,4 veces más en los pacientes sometidos a precorte/esfinterotomía, ajustado por edad (IC 95%: OR 1,02-5,43; p = 0,045). Conclusiones: Este estudio demuestra que la frecuencia de complicación es similar a lo publica- do por otros investigadores, sin embargo, esta cifra se podría reducir más si la CPRE se realiza sólo con fines terapéuticos, por médicos endoscopista altamente calificados. © 2012 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. Todos los derechos reservados.Introduction MethodsEndoscopic retrograde cholangiopancreatography (ERCP) is An analysis of 1.168 patients was carried out from Januarya useful study in the approach to diseases of the biliary and 2002 to December 2011 at the Endoscopy Department of thepancreatic ducts. It was first employed for diagnostic purpo- Hospital General Regional No. 1. Twenty-three patientsses, but currently the worldwide tendency is its use for the- were excluded because they were under the age of 18 yearsrapeutic ends. Imaging studies such as Nuclear Magnetic and/or because they did not hand in their informed consentResonance Cholangiography, now considered the criterion forms for study participation. Thirty-four variables werestandard, have displaced diagnostic ERCP1-3. ERCP requires a evaluated that included medical history, laboratory tests,broad knowledge of anatomy and mastery of the endoscopic imaging studies, findings during ERCP, and associated com-techniques of precut, sphincterotomy, ampulla of Vater di- plications. Complications and their severity were definedlatation, etc., and it is not exempt from anesthetic compli- based on the published work of Cotton PB et al. (table 1)16.cations, pancreatitis, perforation, and hemorrhage4-6. The The data were statistically analyzed using measures of cen-complication rate during the early stages of ERCP develop- tral tendency, dispersion, and confidence intervals (CI). Thement fluctuated between 8,0% and 10,0%, on a worldwide Student’s t test was used to compare the means of the quanti-level, and the mortality rate was 1,0%7. In the United States tative variables among interest groups. Odds ratios weremore than 500.000 ERCPs are performed per year, with an estimated by means of a multiple logistic regression analy-annual report of 50.000 cases presenting with complica- sis. All analyses were done using the Intercooled Stata sta- tistical software, special edition 11,1. A significance valuetions, and 500 cases ending in death. The frequency of post- of 5,0% was considered statistically significant.ERCP pancreatitis is from 0,9% to 2,1% and there is anaverage mortality of 1,0%8-9. ERCP is most commonly in-dicated for choledocolithiasis10-12. Data reported in the interna- Resultstional literature on post-ERCP complications are varied, due The final study sample was made up of 1.145 patients. Meanto methodological differences13-15 and so we decided to ca- age was 55,3 years (SD=18,7; 95% CI: 54,2-56,3). A total ofrry out a prolective, observational, and longitudinal study 36,8% (n=421) of the participants were older than 65 yearsfor the purpose of determining acquired experience, com- of age and 60,5% (n=693) were women (table 2). It is worthplication frequency, and the risk factors associated with the mentioning that the proportion of women was always higherperformance of ERCP at the Hospital General Regional No. 1 in relation to men, and the mean age of women was 52,3(HGR No. 1) of the Instituto Mexicano del Seguro Social in years (SD=19,2) vs 59,9 years (SD=16,8) for men, represen-Culiacán, Sinaloa, Mexico. ting a significant statistical difference with p=0,002.
  3. 3. Endoscopic retrograde cholangiopancreatography at a regional hospital of the IMSS, 2002-2011 127 Table 1 Post-ERCP complication criteria Mild Moderate Severe Hemorrhage Clinical evidence of bleeding (not Transfusion 4 units with no Transfusion 5 units or surgery. just endoscopic); Drop in need for surgery. hemoglobin 3 g with no need for transfusion. Perforation Possibility or suspicion of contrast Perforation established, Medical treatment for more than material leakage treated with fluids requiring treatment for more 10 days or surgical intervention. or suction for at least 3 days. than 4 and up to 10 days. Pancreatitis Clinical presentation of pancreatitis, Pancreatitis requiring Pancreatitis requiring amylase 3 times its normal value hospitalization for 4 to 10 days. hospitalization for more than 10 in the first 24 postoperative hours days or hemorrhagic pancreatitis. requiring hospitalization for 2 to 3 days. Cholangitis Fever 38º at 24 to 48 hrs. Fever requiring hospitalization Septic shock or surgery. 3 days, endoscopic treatment, or percutaneous intervention. Adapted and modified from: Cotton PB et al.16 Table 2 Characteristics of patients that underwent ERCP Table 3 Etiology of patients that underwent ERCP Variable n=1145 % Variable n=1145 % Women 693 60,5 Choledocholithiasis 359 31,4 Age (years) Neoplasia 208 18,2 80 104 9,1 Cholangiocarcinoma 77 37,0 65-80 317 27,7 Bismuth I 67 87,0 50-65 297 25,9 50 427 37,3 Bismuth II 6 7,8 Jaundice 688 60,1 Bismuth III 1 1,2 Abnormal LFTs 718 62,7 Bismuth IV 3 3,9 Biliary lithiasis by ultrasound 137 12,0 Postoperative ductus choledocus 13 1,1 ligature Biliary dyskinesia 2 0,2 History of pancreatitis 30 2,6 LFTs: Liver function tests. after the procedure. In very few cases, follow-up coincided with the patient’s admission to the emergency room or with a direct communication from the patient’s relatives. Age and endoscopic cut (precut/sphincterotomy) were In relation to etiology, choledocolithiasis and pancreatic factors associated with complications in this study. The oddsand biliary tumor frequency was 31,4% (n=359) and 18,2% ratio for complication risk in the group of patients that re-(n= 208), respectively, and cholangiocarcinoma represented ceived treatment was 1,4 (95% CI: 1,02-5,43, p=0,045).37,0% (n=77) of the tumor total. Therapeutic endoscopy re-presented 51,0% of the total of studies performed. It is im-portant to mention the therapeutic use of ERCP at ourhospital in postoperative lesions of the biliary tract, sincewe had thirteen cases (1,1%) (table 3). A total of 23,8% (n=271) of the patients were smokers, the Table 4 Post-ERCP complicationsman-to-woman ratio was 1,8:1,0, and 1,2% (n=17) of the Variable n=1145 %patients presented with periampullary diverticula, makingaccess to the biliary tract difficult (9/17, 52,94%). Hemorrhage 14 1,2 The study complication frequency was 2,1% (n=24). He- Acute pancreatitis 6 0,5morrhage was the most common finding and was self-limi- Respiratory distress 3 0,3ted in the majority of cases. Injection of norepinephrine at Cholangitis 1 0,11:10.000 and blood transfusion were required in onlyone case (table 4). Follow-up was carried out at the outpa- Total 24 2,1tient service of the Gastroenterology Department 30 days
  4. 4. 128 G.A. Reyes-Moctezuma et alDiscussion ConclusionsThis cohort analysis is the first of its kind to be carried out in In conclusion, this study characterized a large series of en-Northeastern Mexico. From a total of 1.145 patients that doscopic procedures (ERCP) in a regional hospital of the Ins-underwent ERCP at this hospital unit over a 10-year period, tituto Mexicano del Seguro Social, in which the frequencythe frequency of complications observed in the present stu- and number of complications and contributing risk factorsdy was 2,1%, and they were associated with precut and were reported. Careful patient selection is important be-sphincterotomy17. It should be mentioned that the complica- cause by combining the abovementioned information withtion frequency found in our study was lower than that reported the technical ability of the therapeutic endoscopist, compli-i n di f f e re nt pa r t s o f t h e w o r l d . We b e l i eve t h i s cations will be reduced. We suggest that ERCP be performedis due to the fact that 49,0% of the procedures were diag- only by highly qualified endoscopists.nostic. We have used precut more frequently over the lastfew years and it is very likely that once the number of com- Financial disclosureplications has been analyzed, it will be used even more.Another factor that perhaps influenced our complication No financial support was received in relation to this article.percentage is the fact that no residents participated in the pro-cedures and they were always performed by 2 endoscopists; Conflict of Interestof course this possibility would need to be confirmed The authors declare that there is no conflict of interest.through controlled studies. The order of frequency of com-plications in published reports is: pancreatitis, hemorrhage,cholangitis, and perforation16. In the present study, hemorr- Acknowledgementshage (n=14) was the most frequent complication, followed We wish to thank all the medical and nonmedical colleaguesby pancreatitis (n=6), respiratory distress (n=3), and cholan- at the endoscopy unit for their help in collecting the datagitis (n=1). Our 3 cases of respiratory distress (0,3%) alerted that allowed us to write this article.us to the necessity of opportune management, given thathaving different anesthesiologists working with us duringthe procedure is a characteristic of our hospital. The drug that Referencesis predominantly used is a combination of propofol and fen-tanyl, which could possibly contribute to the presentation 1. Yarmuch. J G, Navarrete MF, Lembach HJ, Molina JC.of this complication4. Rendimiento de la Colangiopancreatografía por resonancia ma- The definition of hemorrhage varies, and hemoglobin figu- gnética respecto a la Colangiopancreatografía endoscópica ret-res from 2-3 g/dL are accepted; this is significant when rograda en el diagnóstico de coledocolitiasis. Rev Chilena deblood transfusion is required18. In our study population there Cirugía 2008; 60: 122-6.were 14 cases (1,2%) in which 93,0% of the patients presen- 2. Laokpessi A, Bouillet P, Sautereau D, et al. Value of magnetic resonance cholangiography in the preoperative diagnosis ofted with mild hemorrhage and only one patient (7,0%) pre- common bile duct stones. Am J Gastroenterol 2001;96: 2354-9.sented with moderate hemorrhage according to international 3. Shanmugam V, Beattie GC, Yule SR, et al. Is magnetic reso-criteria16, requiring blood transfusion without surgery. This nance cholangiopancreatography the new gold standard in bil-patient had the significant history of taking nonsteroidal iary imaging? Br J Radiol. 2005;78:888-93.anti-inflammatory drugs, stressing the importance of ca- 4. Rex DK, Deenadayalu VP, Eid E, et al. endoscopist- Directed Ad-rrying out a rigorous and detailed anamnesis of our patients. ministration of Propofol: A Worldwide safety Experience. Gas- Pancreatitis frequency published in prospective studies is troenterology 2009; 137:1229-37.from 1,3% to 7,6%19-21 and in our study it was 0,5%. As mentioned 5. Christoforidis E, Goulimaris I, Kanellos I, et al. Post-endoscopicabove, this could increase when a greater number of thera- retrograde cholangiopancreatography pancreatitis and hypera-peutic endoscopies are performed, because precut and sphinc- mylasemia: patient-related and operative risk factors. Endos- copy 2002;34:286-92.terotomy are the risk factors for its presentation22-25. Another 6. Christensen M, Matzen P, Schulze S, et al. Complications offactor that raises the number of complications is the ampulla of ERCP: a prospective study Gastrointest Endosc 2004;60:721-31.Vater dilatation and the technical difficulty in cannulizing 7. Freeman ML. Adverse outcomes of ERCP. Gastrointest Endoscand gaining access to the biliary tract26-31, given that the 2002;56(6 Suppl): S273-82.type and frequency of complications described in the literature 8. Mallery JS, Baron TH, Dominitz JA, et al. Complications of ERCPvary up to 10,0%32-33. Gastrointest Endosc 2003;57:633-8. Due to methodological problems as well as to diverse de- 9. Consulted 27 October 2008. http://www.endonurse.com/arti-finitions, complication frequency is not yet completely cles/ins-outs-ercp.htmldetermined and fluctuates from 1,3% to 10,0%, with a mor- 10. Katz D, Nikfarjam M, Sfakiotaki A, Christophi C. Selective Endo-tality of 2,0% to 4,0%. It must be clearly stated that ERCP is scopic Cholangiography for the Detection of Common Bile Duct Stones in Patients with Cholelithiasis. Endoscopy 2004;36:1145-9.a complex procedure with significant morbidity and mortali- 11. Saccomani G, Durante V, Magnolia MR et al. Combined endo-ty that should be performed by qualified endoscopists with scopic treatment for cholelithiasis associated with choledocholith-experience at the therapeutic level in order to reduce the iasis. Surg Endosc 2005;19:910-4.percentage of complications34-35. There were no fatal outco- 12. Ganci C, Chan C, Bobadilla J, et al. Management of choledo-mes in our study and the endoscopic studies were perfor- cholithiasis found during laparoscopic cholecystectomy: amed by highly competent personnel. strategy based on the use postoperative endoscopic retrograde
  5. 5. Endoscopic retrograde cholangiopancreatography at a regional hospital of the IMSS, 2002-2011 129 cholangiography and sphincterectomy. Rev Invest Clin 24. American Society for Gastrointestinal Endoscopy. Complication 2001;53:17-20. of ERCP. Gastrointest Endosc 2003;57:633-8.13. Madhotra R, Cotton PB, Vaughn J, et al. Analyzing ERCP prac- 25. Lella F, Bagnolo C, Colombo E, et al. A simple way of avoiding tice by a modified degree of difficulty scale: a multicenter da- post-ERCP pancreatitis. Gastrointest Endosc 2004;59:830-4. tabase analysis. Am J Gastroenterol 2000;95:2480-1. 26. Hajiro K, Tsujimura D, Inoue R, et a. Effect of FOY on hyperam-14. Garcia-Cano LJ, Gonzalez-Martin JA, Morillas-Arino J, et al. ylasemia after endoscopic retrograde cholangiopancreatogra- Complications of endoscopic retrograde cholangiopancreatog- phy. Gendai Iryo 1978;10:1375-9. raphy. A study in a small ERCP unit. Rev Esp Enferm Dig 27. Shimizu Y, Takahashi H, Deura M. Prophylactic effects of preop- 2004;96:163-73. erative administration of gabexate mesilate (FOY) on post-ER-15. Suissa A, Yassin K, Lavy A et al. Outcome and early complica- CP pancreatitis. Gendai Iryo 1979;11:540-4. tions of ERCP: a prospective single center study. Hepatogastro- 28. Poon RT, Yeumg C, Lo Cm, Yeum WK, et al. Prophylactic effect enterology 2005;52:352-5 of somatostatin on post-ERCP pancreatitis: a randomized con-16. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterot- trolled trial. Gastrointest Endosc 1999;49:593-8. omy complications and their management: an attempt at con- 29. Andriulli A, Clemente R, Solmi L, et al. Gabexate or somatosta- sensus. Gastrointest Endosc 1991;37:383-93. tin administration before ERCP in patients at high risk for post-17. Cotton PB, Garrow DA, Gallagher J, et al. Risk Factor for com- ERCP pancreatitis: a multicenter, placebo-controlled, rand- plications after ERCP; a multivariate analysis of 11 497 proce- omized clinical trial. Gastrointest Endosc 2002;56:488-95. dures over 12 years. Gastrointest Endosc 2009;70:80-8. 30. Tung-Ping PR, Sheung TF. Antisecretory Agents for Prevention of18. Williams EJ, Taylor S, Fairclough P et al. Risk factor for compli- Post-ERCP Pancreatitis: Rationale for Use and Clinical Results. cations following ERCP; results of a large scale, prospective J Pancreas (online) 2003;4:33-40. multicenter study. Endoscopy 2007;39:793-801. 31. Freeman ML, Nelson DB, Sherman S, et al. Complications of19. Freedman ML, Nelson DB, Sherman S et al. complications of endo- Endoscopic Biliary Sphincterotomy. N Engl J Med 1996;335:909- scopic biliary sphincterotomy. N Engl J Med 1996;335:909-918. 18.20. Loperfido S, Angelini G, Chilovi F et al. Major early complications 32. Sherman S, Lehman GA. Complications of endoscopic retro- from diagnostic and therapeutic ERCP: a prospective multicenter grade cholangiopancreatography and endoscopic sphincteroto- study. Gastrointest Endosc 1998;48:1-10. my: management and prevention. In: Brakin JS, O’phelan CA,21. Sherman S. Ruffolo TA, Hawes RH, et al. Complications of endo- eds. Advanced therapeutic endoscopy. New York: Raven Press scopic sphincterotomy. A prospective series with sphincter of 1990:201-10. Oddi dysfunction and nondilated bile ducts. Gastroenterology 33. Ostroff JW, Shapiro HA. Complications of endoscopic retrograde 1991;101:1068-75. sphincterotomy. In: Jacobsen IM, ed. ERCP: diagnostic and thera-22. Gottlieb K, Sherman S. ERCP and biliary endoscopic sphincter- peutic applications. New York: Elsevier Science 1989:61-73. otomy induced pancreatitis. Gastrointest Endosc Clin N Am 34. Freeman ML. Understanding risk factors and avoiding complica- 1998;8:87-114. tions with endoscopic retrograde cholangiopancreatography. Curr23. Vandervoort J, Soetikno RM, Tham TC et al. Risk factors for Gastroenterol Rep 2003;5:145-153 complications after performance of ERCP. Gastroinest Endosc 35. Masci E, Toti G, Mariani A, et al. Complications of diagnostic 2002;56:652-6. and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol 2001;96:417-23.