1. Revista de Gastroenterología de México. 2012;77(3):125-129
ORIGINAL ARTICLE
Endoscopic retrograde cholangiopancreatography at a regional
hospital of the Instituto Mexicano del Seguro Social, 2002-2011:
risk factors and complications
G. A. Reyes-Moctezumaa,*, L. Sevilla-Suarez-Peredoa,b, M.R. Reyes-Bastidasa, M. A. Ríos-
Ayalac, J. E. Rosales-Lealc, I. Osuna-Ramírezd
a
Department of Gastroenterology and Endoscopy, Hospital General Regional No.1, Instituto Mexicano del Seguro Social,
Culiacán, Sinaloa, Mexico
b
Department of Internal Medicine, Universidad Autónoma de Sinaloa, Culiacán, Sinaloa, Mexico
c
Social Service, Universidad Autónoma de Sinaloa, Culiacán, Sinaloa, Mexico
d
Public Health Research Unit, Universidad Autónoma de Sinaloa, Culiacán, Sinaloa, Mexico
Received 15 February 2012; accepted 23 April 2012
Available 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. 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 Methods
Endoscopic retrograde cholangiopancreatography (ERCP) is An analysis of 1.168 patients was carried out from January
a useful study in the approach to diseases of the biliary and 2002 to December 2011 at the Endoscopy Department of the
pancreatic ducts. It was first employed for diagnostic purpo- Hospital General Regional No. 1. Twenty-three patients
ses, but currently the worldwide tendency is its use for the- were excluded because they were under the age of 18 years
rapeutic ends. Imaging studies such as Nuclear Magnetic and/or because they did not hand in their informed consent
Resonance Cholangiography, now considered the criterion forms for study participation. Thirty-four variables were
standard, 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 defined
latation, 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). The
ment 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 were
more 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 value
tions, 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 an
average mortality of 1,0%8-9. ERCP is most commonly in-
dicated for choledocolithiasis10-12. Data reported in the interna- Results
tional literature on post-ERCP complications are varied, due The final study sample was made up of 1.145 patients. Mean
to 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 of
rry out a prolective, observational, and longitudinal study 36,8% (n=421) of the participants were older than 65 years
for the purpose of determining acquired experience, com- of age and 60,5% (n=693) were women (table 2). It is worth
plication frequency, and the risk factors associated with the mentioning that the proportion of women was always higher
performance 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. 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 odds
and 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 our
hospital in postoperative lesions of the biliary tract, since
we had thirteen cases (1,1%) (table 3).
A total of 23,8% (n=271) of the patients were smokers, the Table 4 Post-ERCP complications
man-to-woman ratio was 1,8:1,0, and 1,2% (n=17) of the
Variable n=1145 %
patients presented with periampullary diverticula, making
access 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 0,5
morrhage was the most common finding and was self-limi- Respiratory distress 3 0,3
ted in the majority of cases. Injection of norepinephrine at
Cholangitis 1 0,1
1:10.000 and blood transfusion were required in only
one case (table 4). Follow-up was carried out at the outpa- Total 24 2,1
tient service of the Gastroenterology Department 30 days

4. 128 G.A. Reyes-Moctezuma et al
Discussion Conclusions
This 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 frequency
the frequency of complications observed in the present stu- and number of complications and contributing risk factors
dy 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 with
tion 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 performed
is 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 last
few years and it is very likely that once the number of com- Financial disclosure
plications 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 Interest
of 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- Acknowledgements
hage (n=14) was the most frequent complication, followed We wish to thank all the medical and nonmedical colleagues
by pancreatitis (n=6), respiratory distress (n=3), and cholan- at the endoscopy unit for their help in collecting the data
gitis (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 that
having different anesthesiologists working with us during
the procedure is a characteristic of our hospital. The drug that References
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