ORIGINAL ARTICLE
Risk Factors of Post-ERCP Pancreatitis at a Tertiary Referral Center in Japan Hiroshi Kakutani, MD, PhD,* Syoryoku Hino, MD, PhD,w Keiichi Ikeda, MD, PhD,* Seita Koyama, MD, PhD,* Naoki Mori, MD, PhD,* Hiroo Imazu, MD, PhD,* Muneo Kawamura, MD, PhD,* and Hisao Tajiri, MD, PhDz
Purpose: Endoscopic retrograde cholangiopancreatography (ERCP) has played a major role in the diagnosis of biliary and pancreatic diseases. The prevalence and mortality rate of postERCP pancreatitis (PEP) remains a serious issue that needs to be resolved. Here, we report the first ERCP study that was conducted at a high-volume center of an educational institution in Japan. Methods: This study investigated patients with suspected biliary and pancreatic diseases who had undergone ERCP between April 2006 and June 2009. We created a database and analyzed preoperative and postoperative data. Patients who had undergone surgery and those with a history of undergoing duodenal papilla treatment were excluded. Results: Mild (n = 62) or moderate (n = 3) pancreatitis was present in 65 cases (6.21%; 36 men and 29 women). A univariate analysis identified age under 50 years (P = 0.01), pancreatography (P < 0.001), and biliary stent placement (P < 0.001). A Multivariate analysis was performed for evaluating the risk factors associated with PEP. This analysis identified age of the patients under 50 years [P = 0.003; odds ratio (OR), 0.37; 95% confidence interval (CI), 0.19-0.71], endoscopic papillary balloon dilation (P = 0.012; OR, 4.69; 95% CI, 1.41-15.54), pancreatography (P < 0.001; OR, 5.55; 95% CI, 2.98-10.33), and plastic stent placement (P < 0.001; OR, 3.77; 95% CI, 2.17-6.54). Descriptive statistics showed that only pancreatography was associated with PEP. An additional sphincterotomy did not increase the risk of PEP (P = 0.306; OR, 2.03; 95% CI, 0.52-7.84), and even adjusted for pancreatography. Conclusions: We changed the size of the stent to 7-Fr. In the future, we plan to repeat the same study with a higher number of cases. Key Words: ERCP, post-ERCP pancreatitis, Japan, risk factor, plastic stent
(Surg Laparosc Endosc Percutan Tech 2014;24:270–273)
E
ndoscopic retrograde cholangiopancreatography (ERCP) has played a major role in the diagnosis of biliary and pancreatic diseases. Today, ERCP is used as a treatment modality for these conditions in conjunction with the advances made in various forms of diagnostic imaging. The
Received for publication September 9, 2012; accepted March 1, 2013. From the Departments of *Endoscopy, The Jikei University School of Medicine; zInternal Medicine, Division of Hepatology and Gastroenterology, The Jikei University School of Medicine, Tokyo; and wDepartment of Neuropsychiatry, Takamatsu Hospital, Kanazawa, Japan. The authors declare no conflicts of interest. Reprints: Hiroshi Kakutani, MD, PhD, Department of Endoscopy, The Jikei University School of Medicine, 105-8471 Minatoku, Nishishinbashi 3-25-8, 105-8461 Tokyo, Japan (e-mail: endosc-kaku @jikei.ac.jp). Copyright r 2014 by Lippincott Williams & Wilkins
270 | www.surgical-laparoscopy.com
number of complications associated with ERCP increases with increase in surgical invasiveness, and the prevalence and mortality rate of post-ERCP pancreatitis (PEP) remains a serious issue that needs to be resolved. To date, many reports on PEP have been published, including those on its prevalence and risk factors. Depending on the illness and treatment methods, the prevalence of PEP ranges widely from 1.6% to 17.8%.1,2 In Japan, ERCP includes preoperative and postoperative administration of pancreatic enzyme inhibitors and antibiotics. At most facilities, including ours, patients are admitted and abstained from having food and drink for approximately 24 hours. Previous PEP studies conducted in Japan, including a retrospective study by a small facility,3 have focused on the posttransplantation risks,4 the association with accessory pancreatic duct patency5 and cholangitis,6 the pancreatic duct guidewire method,7 pancreatic duct stenting,8 endoscopic papillary balloon dilation (EPBD),9 used drugs,10 and pancreatic duct stent in high-risk patients.11 Here, we report the first ERCP study that was conducted at a highvolume center in an educational institution in Japan.
PATIENTS AND METHODS This study investigated patients with suspected biliary and pancreatic diseases who had undergone ERCP between April 2006 and June 2009. We created a database and analyzed preoperative and postoperative data. Patients who had undergone surgery and those with a history of undergoing duodenal papilla treatment were excluded. ERCP was performed after a 24-hour fasting period. The fasting period was ended on the following day if no adverse symptoms or poor hematological results were present. Patients received 0.03 to 0.05 mg/kg of midazolam as intravenous anesthesia and glucagon as a sedative. A dosage of 400 mg/d of gabexate mesilate was administered for 2 days. Amikacin sulfate (200 mg) was mixed with the contrast agent iomeron and saline (2:1). Endoscopes (JF240, TJF240, and JF260V) and cannulas were from Olympus (Tokyo, Japan). A tapered cannula and an endoscopic sphincterotomy (EST) knife were used as required. We did not perform wire-guided cannulation during the study. An expert performed cannulation only after several cannulation attempts by a beginner were unsuccessful. Biliary stents with an 8.5 Fr diameter and 5 to 9 cm in length (Wilson-Cook Medical Inc., Winston-Salem, NC) were used. PEP was defined on the basis of the standard criteria12: new or worsening postprocedural abdominal pain in conjunction with an elevation in serum amylase or lipase levels >3 times the upper limit of normal with or without
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 3, June 2014
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 3, June 2014
radiographic evidence of acute pancreatitis. This clinical study was approved by the Ethics Committee of Jikei University.
Data Analysis To fully understand the early complications of ERCP, we collected patient information from the time of admission to the time of discharge. The primary endpoint of this study was the occurrence of PEP. Data management and statistical calculations were performed using a commercially available statistical software package (version 11.0; Statacorp, College Station, TX). Descriptive statistics were used to demonstrate the demographics of the entire ERCP database and for the subset of patients who underwent biliary stenting. The univariate w2 test or the Fischer exact test was performed to determine whether the possible categorical predictors of interest were associated with the occurrence of PEP. Univariate and multivariate analyses were performed using risk factors such as age, sex, common bile duct (CBD) dilatation, CBD stone, biliary stent insertion, malignant diseases, EST, EPBD, pancreatography, diverticulum, history of pancreatitis, and treatment history. To determine independent predictors, predictive variables with P values
Risk Factors of Post-ERCP Pancreatitis at a Tertiary Referral Center in Japan Hiroshi Kakutani, MD, PhD,* Syoryoku Hino, MD, PhD,w Keiichi Ikeda, MD, PhD,* Seita Koyama, MD, PhD,* Naoki Mori, MD, PhD,* Hiroo Imazu, MD, PhD,* Muneo Kawamura, MD, PhD,* and Hisao Tajiri, MD, PhDz
Purpose: Endoscopic retrograde cholangiopancreatography (ERCP) has played a major role in the diagnosis of biliary and pancreatic diseases. The prevalence and mortality rate of postERCP pancreatitis (PEP) remains a serious issue that needs to be resolved. Here, we report the first ERCP study that was conducted at a high-volume center of an educational institution in Japan. Methods: This study investigated patients with suspected biliary and pancreatic diseases who had undergone ERCP between April 2006 and June 2009. We created a database and analyzed preoperative and postoperative data. Patients who had undergone surgery and those with a history of undergoing duodenal papilla treatment were excluded. Results: Mild (n = 62) or moderate (n = 3) pancreatitis was present in 65 cases (6.21%; 36 men and 29 women). A univariate analysis identified age under 50 years (P = 0.01), pancreatography (P < 0.001), and biliary stent placement (P < 0.001). A Multivariate analysis was performed for evaluating the risk factors associated with PEP. This analysis identified age of the patients under 50 years [P = 0.003; odds ratio (OR), 0.37; 95% confidence interval (CI), 0.19-0.71], endoscopic papillary balloon dilation (P = 0.012; OR, 4.69; 95% CI, 1.41-15.54), pancreatography (P < 0.001; OR, 5.55; 95% CI, 2.98-10.33), and plastic stent placement (P < 0.001; OR, 3.77; 95% CI, 2.17-6.54). Descriptive statistics showed that only pancreatography was associated with PEP. An additional sphincterotomy did not increase the risk of PEP (P = 0.306; OR, 2.03; 95% CI, 0.52-7.84), and even adjusted for pancreatography. Conclusions: We changed the size of the stent to 7-Fr. In the future, we plan to repeat the same study with a higher number of cases. Key Words: ERCP, post-ERCP pancreatitis, Japan, risk factor, plastic stent
(Surg Laparosc Endosc Percutan Tech 2014;24:270–273)
E
ndoscopic retrograde cholangiopancreatography (ERCP) has played a major role in the diagnosis of biliary and pancreatic diseases. Today, ERCP is used as a treatment modality for these conditions in conjunction with the advances made in various forms of diagnostic imaging. The
Received for publication September 9, 2012; accepted March 1, 2013. From the Departments of *Endoscopy, The Jikei University School of Medicine; zInternal Medicine, Division of Hepatology and Gastroenterology, The Jikei University School of Medicine, Tokyo; and wDepartment of Neuropsychiatry, Takamatsu Hospital, Kanazawa, Japan. The authors declare no conflicts of interest. Reprints: Hiroshi Kakutani, MD, PhD, Department of Endoscopy, The Jikei University School of Medicine, 105-8471 Minatoku, Nishishinbashi 3-25-8, 105-8461 Tokyo, Japan (e-mail: endosc-kaku @jikei.ac.jp). Copyright r 2014 by Lippincott Williams & Wilkins
270 | www.surgical-laparoscopy.com
number of complications associated with ERCP increases with increase in surgical invasiveness, and the prevalence and mortality rate of post-ERCP pancreatitis (PEP) remains a serious issue that needs to be resolved. To date, many reports on PEP have been published, including those on its prevalence and risk factors. Depending on the illness and treatment methods, the prevalence of PEP ranges widely from 1.6% to 17.8%.1,2 In Japan, ERCP includes preoperative and postoperative administration of pancreatic enzyme inhibitors and antibiotics. At most facilities, including ours, patients are admitted and abstained from having food and drink for approximately 24 hours. Previous PEP studies conducted in Japan, including a retrospective study by a small facility,3 have focused on the posttransplantation risks,4 the association with accessory pancreatic duct patency5 and cholangitis,6 the pancreatic duct guidewire method,7 pancreatic duct stenting,8 endoscopic papillary balloon dilation (EPBD),9 used drugs,10 and pancreatic duct stent in high-risk patients.11 Here, we report the first ERCP study that was conducted at a highvolume center in an educational institution in Japan.
PATIENTS AND METHODS This study investigated patients with suspected biliary and pancreatic diseases who had undergone ERCP between April 2006 and June 2009. We created a database and analyzed preoperative and postoperative data. Patients who had undergone surgery and those with a history of undergoing duodenal papilla treatment were excluded. ERCP was performed after a 24-hour fasting period. The fasting period was ended on the following day if no adverse symptoms or poor hematological results were present. Patients received 0.03 to 0.05 mg/kg of midazolam as intravenous anesthesia and glucagon as a sedative. A dosage of 400 mg/d of gabexate mesilate was administered for 2 days. Amikacin sulfate (200 mg) was mixed with the contrast agent iomeron and saline (2:1). Endoscopes (JF240, TJF240, and JF260V) and cannulas were from Olympus (Tokyo, Japan). A tapered cannula and an endoscopic sphincterotomy (EST) knife were used as required. We did not perform wire-guided cannulation during the study. An expert performed cannulation only after several cannulation attempts by a beginner were unsuccessful. Biliary stents with an 8.5 Fr diameter and 5 to 9 cm in length (Wilson-Cook Medical Inc., Winston-Salem, NC) were used. PEP was defined on the basis of the standard criteria12: new or worsening postprocedural abdominal pain in conjunction with an elevation in serum amylase or lipase levels >3 times the upper limit of normal with or without
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 3, June 2014
Surg Laparosc Endosc Percutan Tech
Volume 24, Number 3, June 2014
radiographic evidence of acute pancreatitis. This clinical study was approved by the Ethics Committee of Jikei University.
Data Analysis To fully understand the early complications of ERCP, we collected patient information from the time of admission to the time of discharge. The primary endpoint of this study was the occurrence of PEP. Data management and statistical calculations were performed using a commercially available statistical software package (version 11.0; Statacorp, College Station, TX). Descriptive statistics were used to demonstrate the demographics of the entire ERCP database and for the subset of patients who underwent biliary stenting. The univariate w2 test or the Fischer exact test was performed to determine whether the possible categorical predictors of interest were associated with the occurrence of PEP. Univariate and multivariate analyses were performed using risk factors such as age, sex, common bile duct (CBD) dilatation, CBD stone, biliary stent insertion, malignant diseases, EST, EPBD, pancreatography, diverticulum, history of pancreatitis, and treatment history. To determine independent predictors, predictive variables with P values
