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Su1687 Efficacy of Rectal Indomethacin in Combination With Prophylactic Pancreatic Duct Stent in Prevention of Post ERCP Pancreatitis in High-Risk Patient Population
Abstracts
were reported in any of the clinical trials. In a separate meta-analysis, nineteen articles used protease inhibitors as prophylaxis against PEP. A total of five randomized controlled trials used nafamostat mesilate as a prophylaxis against PEP and included 2490 patients, meta-analysis of these studies demonstrates (RR 0.469, 95 %CI 0.331 to 0.666). A total of eight randomized controlled trials used gabexate mesilate as a prophylaxis against PEP and included 3180 patients. Meta-analysis of these studies demonstrates (RR 0.585, 95 %CI 0.427 to 0.81). However, in ulinastatin a total of four randomized controlled trials included 1480 patients, meta-analysis of these studies demonstrates (RR 0.829, 95 %CI 0.552 to1.244). There was no significant statistical or clinical heterogeneity. Conclusion: According to this updated meta-analysis, prophylactic rectal NSAIDs and intravenous nafamostat mesilate were effective in preventing PEP. Significant clinical and economic benefit might be achieved by widespread prophylactic administration of these agents in routine practice.
Su1686 Pancreatic Interventions in ERCP: Pancreatitis Rates and Riskfactors in a National Population-Based Cohort Study Greger Olsson*, Urban Arnelo, Lars Enochsson CLINTEC, Karolinska Institutet, Stockholm, Sweden Background: Pancreatic interventions in ERCP are less frequent than bile duct procedures and little is known about the complications. In this nation-wide populationbased cohort study we analyse the risk factors for pancreatitis in ERCPs targeted towards pancreas. Material and methods: The Swedish Registry for Gallstone Surgery and ERCP (GallRiks) was investigated for all pancreatic interventions performed between 2005 and 2012. The cohort was analysed regarding the rates of post-ERCP pancreatitis (PEP), in comparison with risk factors like age, ASA-classification, gender, indication, procedure time, performing sphincterotomy and use of pancreatic stents. All procedures that were not index-ERCPs, those with an incomplete registrations or directed against the bile ducts were excluded. Results: Totally 45,310 ERCP procedures were included in GallRiks between 2005 and 2012. 2,513 were excluded because not being index-procedures, 31,156 because targeted towards the bile ducts and 3,050 were excluded due to incomplete registration, leaving 8,591 ERCPs to analyse. The overall PEP-rate was 8.1%. If the patient was under 70 years it was 9.7% compared with 6.3% if over 70 years (OR 1.5; CI 1,2-1.7). The PEPrate was 9.5% in women compared with 6.4% in men (OR 0.7; CI 0.6-0.8). In patients with an ASA-class of 1-2 the PEP-rate was 9.2% compared with 5.4% in ASA 3-4 (OR 0.7; CI 0.5-0.8). If the indication of the ERCP was common bile duct stone (CBDS) and the pancreatic duct was cannulated the PEP-rate was 10.5%, compared with an indication of malignancy or jaundice (3.8% respectively 6.2%; OR 0.4; CI 0.3-0.5 respectively OR 0.6; CI 0.5-0.7). If a pancreatic stent was inserted, the PEP-risk increased from 7.8% to 10.7% with an OR of 1.3 (CI 1.0-1.6). If the procedure time exceeded 30 min. the PEP-rate was elevated from 6.3% to 9.2% (OR1.6; CI 1.4-1.9) and if a sphincterotomy was added, the PEP-rate increased from 7.1% to 8.4% (OR 1.2; CI 1.0-1.5). Conclusion: The complication rates in our study were acceptably low with a total pancreatits rate of 8.1% although the pancreatic duct was the subject of the procedure. We identified several risk factors for developing PEP like, age !70 years, an indication of CBDS, ASA 1-2, female gender, adding a sphincterotomy, inserting a pancreatic stent or an operative time O30 minutes.
Su1687 Efficacy of Rectal Indomethacin in Combination With Prophylactic Pancreatic Duct Stent in Prevention of Post ERCP Pancreatitis in High-Risk Patient Population Hari P. Sayana*1, Stephen Simon2, Sreenivasa Jonnalagadda1 1 Gastroenterology and Hepatology, University of Missouri - Kansas City, Kansas City, MO; 2Biomedical and Health informatics, University of Missouri- Kansas City, Kansas City, MO Background: Incidence of post ERCP pancreatitis (PEP) can be as high as 30% in high-risk patients. Rectal indomethacin has shown to decrease PEP rates to up to 9.2% as opposed to 16.9% in the placebo group in a recently published randomized controlled trial. However, the efficacy of its use in routine clinical practice is unknown. Aim: The aim of this study is to assess the efficacy of rectal indomethacin in prevention of PEP in high-risk individuals when used in combination with prophylactic pancreatic duct (PD) stent. Methods: We performed a retrospective review of all the patients who received a dose of rectal Indomethacin and prophylactic PD stent at the time of ERCP from July 2012 to Oct 2013. Pertinent clinical, biochemical and radiological parameters were collected. PEP was defined by the presence of abdominal pain consistent with pancreatitis within 24 hours of ERCP that required hospitalization O2 days, along with either elevation of lipase over 3 times the upper limit of normal level or radiological imaging changes consistent with acute pancreatitis. Results: A total 52 patients met the inclusion criteria. The mean age of all patients was 4814 years with 77 % females (nZ40/52) and 90% Caucasians (nZ47/52). The majority (53.8%, nZ28/52) underwent ERCP for suspected Sphincter of Oddi Dysfunction (SOD) and 10 patients out of them received an empiric biliary sphincterotomy without undergoing manometry. Of those who got manometry evaluation (18/28), 12 had dual sphincterotomy, 6 had either biliary or pancreatic sphincterotomy alone. Other indications include, chronic pancreatitis with pancreatic duct stone or stricture in 13 patients, pancreatic divisum in 5, choledocholithiasis in 3, pancreatic duct leak in 2 and recurrent pancreatitis in 1 patient. The overall incidence of PEP in our groups was 23% (nZ12/52). The incidence of PEP by indication includes, SOD group: 17.2% (5/29), chronic pancreatitis with PD stone removal: 30% (4/13), and pancreatic divisum: 60% (3/5). Within the SOD group (nZ28), 20% (nZ2/10) and 16.6% (nZ3/18) developed PEP in the empiric biliary sphincterotomy group and manometry with subsequent sphincterotomy group respectively. No severe pancreatitis recorded in the SOD group. One patient with chronic pancreatitis and mid body pancreatic duct stone developed severe pancreatitis with pancreatic necrosis, pseudocyst, prolonged ICU care and hospitalization after ERCP (1/53, 1.8%). Conclusion: In contrast to the recently published randomized controlled study, the risk of post ERCP pancreatitis in clinical practice is considerably high, despite the use of a combination of rectal indomethacin and prophylactic PD stent. Further studies are needed to validate the efficacy of rectal indomethacin in prevention of PEP in highrisk patients.
www.giejournal.org
Volume 79, No. 5S : 2014 GASTROINTESTINAL ENDOSCOPY AB259
were reported in any of the clinical trials. In a separate meta-analysis, nineteen articles used protease inhibitors as prophylaxis against PEP. A total of five randomized controlled trials used nafamostat mesilate as a prophylaxis against PEP and included 2490 patients, meta-analysis of these studies demonstrates (RR 0.469, 95 %CI 0.331 to 0.666). A total of eight randomized controlled trials used gabexate mesilate as a prophylaxis against PEP and included 3180 patients. Meta-analysis of these studies demonstrates (RR 0.585, 95 %CI 0.427 to 0.81). However, in ulinastatin a total of four randomized controlled trials included 1480 patients, meta-analysis of these studies demonstrates (RR 0.829, 95 %CI 0.552 to1.244). There was no significant statistical or clinical heterogeneity. Conclusion: According to this updated meta-analysis, prophylactic rectal NSAIDs and intravenous nafamostat mesilate were effective in preventing PEP. Significant clinical and economic benefit might be achieved by widespread prophylactic administration of these agents in routine practice.
Su1686 Pancreatic Interventions in ERCP: Pancreatitis Rates and Riskfactors in a National Population-Based Cohort Study Greger Olsson*, Urban Arnelo, Lars Enochsson CLINTEC, Karolinska Institutet, Stockholm, Sweden Background: Pancreatic interventions in ERCP are less frequent than bile duct procedures and little is known about the complications. In this nation-wide populationbased cohort study we analyse the risk factors for pancreatitis in ERCPs targeted towards pancreas. Material and methods: The Swedish Registry for Gallstone Surgery and ERCP (GallRiks) was investigated for all pancreatic interventions performed between 2005 and 2012. The cohort was analysed regarding the rates of post-ERCP pancreatitis (PEP), in comparison with risk factors like age, ASA-classification, gender, indication, procedure time, performing sphincterotomy and use of pancreatic stents. All procedures that were not index-ERCPs, those with an incomplete registrations or directed against the bile ducts were excluded. Results: Totally 45,310 ERCP procedures were included in GallRiks between 2005 and 2012. 2,513 were excluded because not being index-procedures, 31,156 because targeted towards the bile ducts and 3,050 were excluded due to incomplete registration, leaving 8,591 ERCPs to analyse. The overall PEP-rate was 8.1%. If the patient was under 70 years it was 9.7% compared with 6.3% if over 70 years (OR 1.5; CI 1,2-1.7). The PEPrate was 9.5% in women compared with 6.4% in men (OR 0.7; CI 0.6-0.8). In patients with an ASA-class of 1-2 the PEP-rate was 9.2% compared with 5.4% in ASA 3-4 (OR 0.7; CI 0.5-0.8). If the indication of the ERCP was common bile duct stone (CBDS) and the pancreatic duct was cannulated the PEP-rate was 10.5%, compared with an indication of malignancy or jaundice (3.8% respectively 6.2%; OR 0.4; CI 0.3-0.5 respectively OR 0.6; CI 0.5-0.7). If a pancreatic stent was inserted, the PEP-risk increased from 7.8% to 10.7% with an OR of 1.3 (CI 1.0-1.6). If the procedure time exceeded 30 min. the PEP-rate was elevated from 6.3% to 9.2% (OR1.6; CI 1.4-1.9) and if a sphincterotomy was added, the PEP-rate increased from 7.1% to 8.4% (OR 1.2; CI 1.0-1.5). Conclusion: The complication rates in our study were acceptably low with a total pancreatits rate of 8.1% although the pancreatic duct was the subject of the procedure. We identified several risk factors for developing PEP like, age !70 years, an indication of CBDS, ASA 1-2, female gender, adding a sphincterotomy, inserting a pancreatic stent or an operative time O30 minutes.
Su1687 Efficacy of Rectal Indomethacin in Combination With Prophylactic Pancreatic Duct Stent in Prevention of Post ERCP Pancreatitis in High-Risk Patient Population Hari P. Sayana*1, Stephen Simon2, Sreenivasa Jonnalagadda1 1 Gastroenterology and Hepatology, University of Missouri - Kansas City, Kansas City, MO; 2Biomedical and Health informatics, University of Missouri- Kansas City, Kansas City, MO Background: Incidence of post ERCP pancreatitis (PEP) can be as high as 30% in high-risk patients. Rectal indomethacin has shown to decrease PEP rates to up to 9.2% as opposed to 16.9% in the placebo group in a recently published randomized controlled trial. However, the efficacy of its use in routine clinical practice is unknown. Aim: The aim of this study is to assess the efficacy of rectal indomethacin in prevention of PEP in high-risk individuals when used in combination with prophylactic pancreatic duct (PD) stent. Methods: We performed a retrospective review of all the patients who received a dose of rectal Indomethacin and prophylactic PD stent at the time of ERCP from July 2012 to Oct 2013. Pertinent clinical, biochemical and radiological parameters were collected. PEP was defined by the presence of abdominal pain consistent with pancreatitis within 24 hours of ERCP that required hospitalization O2 days, along with either elevation of lipase over 3 times the upper limit of normal level or radiological imaging changes consistent with acute pancreatitis. Results: A total 52 patients met the inclusion criteria. The mean age of all patients was 4814 years with 77 % females (nZ40/52) and 90% Caucasians (nZ47/52). The majority (53.8%, nZ28/52) underwent ERCP for suspected Sphincter of Oddi Dysfunction (SOD) and 10 patients out of them received an empiric biliary sphincterotomy without undergoing manometry. Of those who got manometry evaluation (18/28), 12 had dual sphincterotomy, 6 had either biliary or pancreatic sphincterotomy alone. Other indications include, chronic pancreatitis with pancreatic duct stone or stricture in 13 patients, pancreatic divisum in 5, choledocholithiasis in 3, pancreatic duct leak in 2 and recurrent pancreatitis in 1 patient. The overall incidence of PEP in our groups was 23% (nZ12/52). The incidence of PEP by indication includes, SOD group: 17.2% (5/29), chronic pancreatitis with PD stone removal: 30% (4/13), and pancreatic divisum: 60% (3/5). Within the SOD group (nZ28), 20% (nZ2/10) and 16.6% (nZ3/18) developed PEP in the empiric biliary sphincterotomy group and manometry with subsequent sphincterotomy group respectively. No severe pancreatitis recorded in the SOD group. One patient with chronic pancreatitis and mid body pancreatic duct stone developed severe pancreatitis with pancreatic necrosis, pseudocyst, prolonged ICU care and hospitalization after ERCP (1/53, 1.8%). Conclusion: In contrast to the recently published randomized controlled study, the risk of post ERCP pancreatitis in clinical practice is considerably high, despite the use of a combination of rectal indomethacin and prophylactic PD stent. Further studies are needed to validate the efficacy of rectal indomethacin in prevention of PEP in highrisk patients.
www.giejournal.org
Volume 79, No. 5S : 2014 GASTROINTESTINAL ENDOSCOPY AB259