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Tu1472 Safety and Feasibility of Etomidate-Based Sedation Compared With Propofol-Based Sedation in Endoscopic Retrograde Cholangiopancreatography: A Double-Blind, Randomized, Non-Inferiority Trial
Abstracts
Tu1471 Digital, Single-Operator Cholangiopancreatoscopy in the Diagnosis and Management of Pancreatobiliary Disorders: Results From the Multicenter Czech and Slovak National Database Rastislav Hustak*1,2, Jan Král3, Filip Neumann4, Vladimír Nosek5, Eva Skanderová6, Ján Usák1, Ondrej Urban6, Bohus Bunganic7, Miroslav Zavoral7, Olga Shonova8, Petr Vitek9, Julius Spicak3, Jan Martinek3 1 University Hospital of Trnava and FZSPTU, Trnava, Slovakia; 21st Faculty of Medicine, Charles University, Prague, Czech Republic; 3 Institute for Clinical and Experimental Medicine, Prague, Czech Republic; 4Kolín Hospital, Kolin, Czech Republic; 5Hospital Jablonec nad Nisou, Jablonec nad Nisou, Czech Republic; 6Vítkovice Hospital, Ostrava Vítkovice, Czech Republic; 71 Faculty of Medicine, Charles University, Military University Hospital, Prague, Czech Republic; 8Hospital Ceské Budejovice, Ceské Budejovice, Czech Republic; 9Hospital Frydek-Mistek, Frydek-Mistek, Czech Republic Introduction: Digital cholangioscopy provides higher-resolution imaging of the pancreatobiliary tract compared to the 1st generation. The impact of a new singleoperator digital cholangioscope (d-SOC) in diagnosis and treatment of pancreatobiliary diseases has not been intensely assessed. The aim of this retrospective analysis of prospective case series from 8 centers from the Czech (nZ7) and Slovak (nZ1) Republics was to assess:(1) diagnostic yield of d-SOC visual diagnosis and biopsies in patients with undetermined biliary strictures;(2) the efficacy of d-SOC directed treatment of difficult lithiasis and (3) to analyze procedure related adverse events (AEs). Methods: The main outcomes were:(1) sensitivity and specificity for visual diagnosis with/without biopsies of d-SOC;(2) achievement of a complete duct clearance in patients with difficult lithiasis;(3) procedure related AEs. Results: A total of 150 patients underwent 166 d-SOC procedures (165 cholangioscopies and 1 pancreatoscopy); 81 (48.8%) for diagnostic intents (with biopsy in 66/81 patients (81.5%), and 85 (51.2%) for stone lithotripsy (1 patient had pancreaticolithiasis). The most frequent indication for diagnostic d-SOC was undetermined stenosis (nZ58). Reliable views of a target lesion were obtained in all patients. The sensitivity, specificity and diagnostic accuracy of d-SOC for visual diagnosis of malignant lesion was 92.3% (95%CI, 73.4–98.7), 82.5% (66.6–92.1) and 85.9% (77.6–94.4). The mean number of biopsies obtained per patient was 4 (range 1–13) and the specimen was adequate for histopathological analysis in 95.5% of patients (63/66). The sensitivity, specificity and diagnostic accuracy of d-SOC guided biopsies for malignancy were 83.3% (95%CI, 64.5–93.7), 96.8% (81.5–99.8) and 88.7% (82.3–98.1). The diagnostic accuracy of visual inspection was not statistically influenced by the presence of biliary stent (Yates’ p-0.9). Of 63 patients attended for d-SOC-guided stone therapy, a complete intraductal clearance was achieved in one session in 37 and in two sessions in 10 patients, respectively and the overall success rate was 75%. A total of 11 patients (11/166; 6.6%) experienced an adverse event (cholangitis nZ6, pancreatitis nZ3, perforation nZ2), one patient with severe cholangitis died. The incidence of cholangitis was higher among patients who had received prophylactic antibiotics (nZ5) compared to those who had not received it (nZ1). Conclusion: Our, so far the largest case series analyzing outcomes and safety of d-SOC shows that:(1) It provides high diagnostic yield in patients with undetermined biliary stenosis;(2) The SOC directed biopsies have a high diagnostic accuracy;(3) d-SOC guided stone lithotripsy is effective in three quarters of patients and (4) Severe adverse events may occur and prophylactic antibiotics may not be effective in preventing post-dSOC cholangitis.
Tu1472 Safety and Feasibility of Etomidate-Based Sedation Compared With Propofol-Based Sedation in Endoscopic Retrograde Cholangiopancreatography: A Double-Blind, Randomized, Non-Inferiority Trial Chan Hyuk Park*1, Se Woo Park2 1 Department of Internal Medicine, Hanyang University College of Medicine, Guri, Korea (the Republic of); 2Department of Internal Medicine, Hallym University College of Medicine, Hwasung, Korea (the Republic of) Introduction: Etomidate is a short-acting intravenous hypnotic with a safety profile that is superior to alternative drugs such as propofol. However, there is a lack of evidence on the safety of etomidate in advanced endoscopic procedures, especially endoscopic retrograde cholangiopancreatography (ERCP). Methods: This singlecenter, randomized, double-blind, non-inferiority trial included patients with American Society of Anesthesiologists physical status I–II who had been scheduled for ERCP. All patients received 0.05 mg/kg of midazolam intravenously as pretreatment before receiving etomidate or propofol. Either etomidate or propofol was then administered according to group allocation. The primary endpoint was a res-
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piratory event such as apnea (5 s) or desaturation (SpO2 <90%). A non-inferiority margin of 10% was assumed. Results: Sixty-three and 64 patients were enrolled in the etomidate and propofol groups, respectively. Respiratory events were identified in 10 patients (15.6%) of the etomidate group and 16 patients (25.4%) of the propofol group, with a rate difference of -9.8% (one-sided 97.5% confidence interval, -N to 4.2%). The overall incidence of cardiovascular events tended to be higher in the etomidate group (67.2% vs. 50.8%, P Z 0.060). In particular, tachycardia (heart rate >100 beats/min) was more common in the etomidate group than in the propofol group (64.1% vs. 34.9%, P Z 0.001). Shock tended to be less common in the etomidate group (6.3 vs. 15.9%, P Z 0.084). Conclusions: Etomidate-based sedation during ERCP was non-inferior to propofol-based sedation in terms of the overall incidence of respiratory events.
Tu1473 Risk Factors of Duodenal Perforation Caused by Biliary Plastic Stent Migration Jae Woo Lee*, Ji Kon Ryu, Jun Hyuk Son, Jinwoo Kang, Sang Hyub Lee, Yong-Tae Kim Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul, Korea (the Republic of) Background: Migration of biliary plastic stent (PS) inserted by endoscopic retrograde cholangio- pancreatography can cause duodenal perforation and become a lifethreatening condition, yet there is no study revealing its risk factors. We aim to report the incidence of duodenal perforation caused by biliary plastic stent migration and seek the risk factors. Methods: All patients who received endoscopic retrograde cholangiopancreatography with a biliary plastic stent placement at our institution during January 2006 to August 2016 were reviewed. The etiology of disease, diameter, length, type of the PS and time to perforation was reviewed. Results: A total of 6,371 endoscopic biliary drainage was done and 4,111 with PSs, and 2,994 with straight PS including 713 Tannenbaum stents. Eight patients with duodenal perforation caused by biliary PS were identified and all of the cases had at least one straight PS inserted. Duodenal perforation occurred in 0.27% of straight PS cases. All of these cases had at least 12cm long straight PS inserted. Two of them had benign stricture and six of them had malignant stricture. Time to perforation ranged between 2 to 84 days. Straight PSs 12cm (pZ0.001) or longer and malignant etiology (pZ0.010) were the risk factors of duodenal perforation caused by biliary PS migration. Conclusion: The incidence of duodenal perforation caused by biliary PS migration is about 0.27% of straight PS cases. Straight PS at least 12cm long and malignant etiology were the risk factors of duodenal perforation caused by PS migration.
Tu1474 Risk Factor of Bleeding After Sphincterotomy During Endoscopic Retrograde Cholangiopancreatography in Average Risk Patients Dong Wook Lee*, Ho Gak Kim, Jimin Han, Sang Soo Bae, Jae Young Oh, Min Keun Kim Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea (the Republic of) Backgroud & Aims: Endoscopic retrograde cholangiopancreatography (ERCP) is widely used for treatment of various pancreaticobiliary disease. For therapeutic ERCP, endoscopic sphincterotomy is often necessary but it can lead to complications such as bleeding. Thus we investigated the risk factors of post-ES bleeding in average risk patients. Methods: We retrospectively reviewed the medical records of patients who had been treated for ERCP between April 2006 and March 2013. The length of the ES incision was defined as minimal, (up to the proximal hooding fold), medium (between minimal and full length), full (up to the superior margin of the sphincter opening). Exclusion criteria was as follows: precut sphincterotomy or balloon dilatation was performed, patients having altered anatomy or anticoagulant medication. Antiplatelet agent was discontinued for 7 days before ES. Results: A total of 3,620 patient underwent ERCP and 1,121 patients who underwent biliary ES were enrolled. Post-ES bleeding occurred in 108 of 1,121 patients (9.6%) and mostly minor bleeding (94 patients, 87%). Length of ES was the only risk factor for post-ES bleeding in multivariate analysis. Complete hemostasis was achieved by endoscopic modalities and no serious complication developed in all bleeding patients. Conclusion: In average risk patients, the length of the ES incision was confirmed as independent risk factors for post-ES bleeding and endoscopic hemostasis should be considered at first and it is an effective and safe enough
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB641
Tu1471 Digital, Single-Operator Cholangiopancreatoscopy in the Diagnosis and Management of Pancreatobiliary Disorders: Results From the Multicenter Czech and Slovak National Database Rastislav Hustak*1,2, Jan Král3, Filip Neumann4, Vladimír Nosek5, Eva Skanderová6, Ján Usák1, Ondrej Urban6, Bohus Bunganic7, Miroslav Zavoral7, Olga Shonova8, Petr Vitek9, Julius Spicak3, Jan Martinek3 1 University Hospital of Trnava and FZSPTU, Trnava, Slovakia; 21st Faculty of Medicine, Charles University, Prague, Czech Republic; 3 Institute for Clinical and Experimental Medicine, Prague, Czech Republic; 4Kolín Hospital, Kolin, Czech Republic; 5Hospital Jablonec nad Nisou, Jablonec nad Nisou, Czech Republic; 6Vítkovice Hospital, Ostrava Vítkovice, Czech Republic; 71 Faculty of Medicine, Charles University, Military University Hospital, Prague, Czech Republic; 8Hospital Ceské Budejovice, Ceské Budejovice, Czech Republic; 9Hospital Frydek-Mistek, Frydek-Mistek, Czech Republic Introduction: Digital cholangioscopy provides higher-resolution imaging of the pancreatobiliary tract compared to the 1st generation. The impact of a new singleoperator digital cholangioscope (d-SOC) in diagnosis and treatment of pancreatobiliary diseases has not been intensely assessed. The aim of this retrospective analysis of prospective case series from 8 centers from the Czech (nZ7) and Slovak (nZ1) Republics was to assess:(1) diagnostic yield of d-SOC visual diagnosis and biopsies in patients with undetermined biliary strictures;(2) the efficacy of d-SOC directed treatment of difficult lithiasis and (3) to analyze procedure related adverse events (AEs). Methods: The main outcomes were:(1) sensitivity and specificity for visual diagnosis with/without biopsies of d-SOC;(2) achievement of a complete duct clearance in patients with difficult lithiasis;(3) procedure related AEs. Results: A total of 150 patients underwent 166 d-SOC procedures (165 cholangioscopies and 1 pancreatoscopy); 81 (48.8%) for diagnostic intents (with biopsy in 66/81 patients (81.5%), and 85 (51.2%) for stone lithotripsy (1 patient had pancreaticolithiasis). The most frequent indication for diagnostic d-SOC was undetermined stenosis (nZ58). Reliable views of a target lesion were obtained in all patients. The sensitivity, specificity and diagnostic accuracy of d-SOC for visual diagnosis of malignant lesion was 92.3% (95%CI, 73.4–98.7), 82.5% (66.6–92.1) and 85.9% (77.6–94.4). The mean number of biopsies obtained per patient was 4 (range 1–13) and the specimen was adequate for histopathological analysis in 95.5% of patients (63/66). The sensitivity, specificity and diagnostic accuracy of d-SOC guided biopsies for malignancy were 83.3% (95%CI, 64.5–93.7), 96.8% (81.5–99.8) and 88.7% (82.3–98.1). The diagnostic accuracy of visual inspection was not statistically influenced by the presence of biliary stent (Yates’ p-0.9). Of 63 patients attended for d-SOC-guided stone therapy, a complete intraductal clearance was achieved in one session in 37 and in two sessions in 10 patients, respectively and the overall success rate was 75%. A total of 11 patients (11/166; 6.6%) experienced an adverse event (cholangitis nZ6, pancreatitis nZ3, perforation nZ2), one patient with severe cholangitis died. The incidence of cholangitis was higher among patients who had received prophylactic antibiotics (nZ5) compared to those who had not received it (nZ1). Conclusion: Our, so far the largest case series analyzing outcomes and safety of d-SOC shows that:(1) It provides high diagnostic yield in patients with undetermined biliary stenosis;(2) The SOC directed biopsies have a high diagnostic accuracy;(3) d-SOC guided stone lithotripsy is effective in three quarters of patients and (4) Severe adverse events may occur and prophylactic antibiotics may not be effective in preventing post-dSOC cholangitis.
Tu1472 Safety and Feasibility of Etomidate-Based Sedation Compared With Propofol-Based Sedation in Endoscopic Retrograde Cholangiopancreatography: A Double-Blind, Randomized, Non-Inferiority Trial Chan Hyuk Park*1, Se Woo Park2 1 Department of Internal Medicine, Hanyang University College of Medicine, Guri, Korea (the Republic of); 2Department of Internal Medicine, Hallym University College of Medicine, Hwasung, Korea (the Republic of) Introduction: Etomidate is a short-acting intravenous hypnotic with a safety profile that is superior to alternative drugs such as propofol. However, there is a lack of evidence on the safety of etomidate in advanced endoscopic procedures, especially endoscopic retrograde cholangiopancreatography (ERCP). Methods: This singlecenter, randomized, double-blind, non-inferiority trial included patients with American Society of Anesthesiologists physical status I–II who had been scheduled for ERCP. All patients received 0.05 mg/kg of midazolam intravenously as pretreatment before receiving etomidate or propofol. Either etomidate or propofol was then administered according to group allocation. The primary endpoint was a res-
www.giejournal.org
piratory event such as apnea (5 s) or desaturation (SpO2 <90%). A non-inferiority margin of 10% was assumed. Results: Sixty-three and 64 patients were enrolled in the etomidate and propofol groups, respectively. Respiratory events were identified in 10 patients (15.6%) of the etomidate group and 16 patients (25.4%) of the propofol group, with a rate difference of -9.8% (one-sided 97.5% confidence interval, -N to 4.2%). The overall incidence of cardiovascular events tended to be higher in the etomidate group (67.2% vs. 50.8%, P Z 0.060). In particular, tachycardia (heart rate >100 beats/min) was more common in the etomidate group than in the propofol group (64.1% vs. 34.9%, P Z 0.001). Shock tended to be less common in the etomidate group (6.3 vs. 15.9%, P Z 0.084). Conclusions: Etomidate-based sedation during ERCP was non-inferior to propofol-based sedation in terms of the overall incidence of respiratory events.
Tu1473 Risk Factors of Duodenal Perforation Caused by Biliary Plastic Stent Migration Jae Woo Lee*, Ji Kon Ryu, Jun Hyuk Son, Jinwoo Kang, Sang Hyub Lee, Yong-Tae Kim Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul, Korea (the Republic of) Background: Migration of biliary plastic stent (PS) inserted by endoscopic retrograde cholangio- pancreatography can cause duodenal perforation and become a lifethreatening condition, yet there is no study revealing its risk factors. We aim to report the incidence of duodenal perforation caused by biliary plastic stent migration and seek the risk factors. Methods: All patients who received endoscopic retrograde cholangiopancreatography with a biliary plastic stent placement at our institution during January 2006 to August 2016 were reviewed. The etiology of disease, diameter, length, type of the PS and time to perforation was reviewed. Results: A total of 6,371 endoscopic biliary drainage was done and 4,111 with PSs, and 2,994 with straight PS including 713 Tannenbaum stents. Eight patients with duodenal perforation caused by biliary PS were identified and all of the cases had at least one straight PS inserted. Duodenal perforation occurred in 0.27% of straight PS cases. All of these cases had at least 12cm long straight PS inserted. Two of them had benign stricture and six of them had malignant stricture. Time to perforation ranged between 2 to 84 days. Straight PSs 12cm (pZ0.001) or longer and malignant etiology (pZ0.010) were the risk factors of duodenal perforation caused by biliary PS migration. Conclusion: The incidence of duodenal perforation caused by biliary PS migration is about 0.27% of straight PS cases. Straight PS at least 12cm long and malignant etiology were the risk factors of duodenal perforation caused by PS migration.
Tu1474 Risk Factor of Bleeding After Sphincterotomy During Endoscopic Retrograde Cholangiopancreatography in Average Risk Patients Dong Wook Lee*, Ho Gak Kim, Jimin Han, Sang Soo Bae, Jae Young Oh, Min Keun Kim Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea (the Republic of) Backgroud & Aims: Endoscopic retrograde cholangiopancreatography (ERCP) is widely used for treatment of various pancreaticobiliary disease. For therapeutic ERCP, endoscopic sphincterotomy is often necessary but it can lead to complications such as bleeding. Thus we investigated the risk factors of post-ES bleeding in average risk patients. Methods: We retrospectively reviewed the medical records of patients who had been treated for ERCP between April 2006 and March 2013. The length of the ES incision was defined as minimal, (up to the proximal hooding fold), medium (between minimal and full length), full (up to the superior margin of the sphincter opening). Exclusion criteria was as follows: precut sphincterotomy or balloon dilatation was performed, patients having altered anatomy or anticoagulant medication. Antiplatelet agent was discontinued for 7 days before ES. Results: A total of 3,620 patient underwent ERCP and 1,121 patients who underwent biliary ES were enrolled. Post-ES bleeding occurred in 108 of 1,121 patients (9.6%) and mostly minor bleeding (94 patients, 87%). Length of ES was the only risk factor for post-ES bleeding in multivariate analysis. Complete hemostasis was achieved by endoscopic modalities and no serious complication developed in all bleeding patients. Conclusion: In average risk patients, the length of the ES incision was confirmed as independent risk factors for post-ES bleeding and endoscopic hemostasis should be considered at first and it is an effective and safe enough
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB641