448 a prospective randomized multicenter trial comparing early precut and standard approach for...

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High Volume Endoscopist (HVE) vs Low Volume Endoscopist (LVE) Parameter HVE N253 Mean(S.D.) LVE N78 Mean(S.D.) % change p-value Dose Area Product (Gycm^2) 11.32 (9.18) 21.26 (23.54) HVE 47% lower P0.0001 Effective Dose (mSv) 2.12 (2.49) 4.29 (6.3) HVE 50% lower P0.0001 Fluoro Time (minutes) 4.3 (3.28) 5.56 (6.22) HVE 23% lower P0.05 Procedure Complexity 2.37 (0.76) 1.99 (0.61) HVE 19% higher P0.0001 Fluoro Complexity 4.91 (1.92) 3.63 (1.31) HVE 35% higher P0.0001 DAP/Procedure Complexity 5.05 (4.11) 10.6 (10.67) HVE 52% lower P0.0001 DAP/Fluoro Complexity 2.62 (2.62) 5.89 (5.22) HVE 56% lower P0.0001 Fluoroscopy Complexity Score CATEGORY SCORE CBD cannulation 1 PD cannulation 1 sphincterotomy 1 non hilar stricture 1 hilar stricture 2 dilation 1 brushing 1 stone balloon sweep 1 stone basket sweep 1 Lithotripsy, mechanical or EHL 1 choledochoscopy 1 stent (metal or plastic) 1 biopsy 1 prior stent 1 whipple or billroth 2 1 447 DGT vs TPS in Patients With Initial PD Cannulation by Chance; Prospective Randomized Multi-Center Study Sang-Woo Cha* 1 , Sae Hee Kim 2 , Anna Kim 2 , Eun Taek Park 3 , Kyo-Sang Yoo 4 , Moo in Park 3 , Seun Ja Park 3 , Young Deok Cho 1 1 Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, Republic of Korea; 2 Department of Internal Medicine, Eulji University Hospital, Deajeon, Republic of Korea; 3 Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea; 4 Departmemt of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea Background/Aim: Successful cannulation of the common bile duct (CBD) is an important benchmark of ERCP. Repeated cannulation for CBD is one of the main risk factors for post-ERCP pancreatitis. Recently, pancreatic duct guidewire assisting bile duct cannulation (double guidewire technique, DGT) or transpancreatic precut sphincterotomy (TPS) have been considered a promising alternative approach in difficult cannulation situations. The aim of this study was to compare the performance of DGT with the TPS in the patients in whom pancreatic duct cannulation was performed initially. Patients/Methods: When guidewire was placed in the pancreatic duct by chance, the patients were then randomized into DGT or TPS groups. After this, bile duct cannulation was retried using DGT or TPS. Main outcome measurements were frequency of successful CBD cannulation and post-procedure related complications. Results: The groups were similar with regard to patient demographics. A total of 81 patients were enrolled. 39 patients were assigned to the DGT group and 42 to the TPS. Successful CBD cannulation was achieved in 31 (79.5%) of 39 patients in the DGT group and 39 (92.9%) of 42 patients in the TPS group. The mean cannulation time was 19.7 minutes in the DGT group and 15 minutes in the TPS group (P 0.054). There was no significant difference in the successful CBD cannulation rate or mean cannulation time after p-duct cannulation between two groups. The overall incidence of post-procedure pancreatitis was 12.8% (5/39) in the DGT group, and 11.9% (5/42) in the TPS group. Post-procedure hyperamylasemia was significantly higher in DGT group (P 0.033). Conclusion: In patients with pancreatic duct cannulation initially by chance, DGT and TPS facilitate biliary cannulation and show the similar success rates. The incidence of post-procedure pancreatitis was similar in the two groups, but post- procedure hyperamylasemia was significantly higher in the DGT group. 448 A Prospective Randomized Multicenter Trial Comparing Early Precut and Standard Approach for Cannulating the Common Bile Duct: An Interim Analysis Alberto Mariani* 1 , Antonella Giussani 1 , Milena Di Leo 1 , Mario Marini 2 , Nicola Giardulllo 3 , Federico Buffoli 4 , Maria Antonia Bianco 5 , Vittorio Terruzzi 6 , Pier Alberto Testoni 1 1 Vita-Salute San Raffaele University, Scientific Institute San Raffaele, Milan, Italy; 2 Azienda Ospedaliera Università Senese, Policlinico Santa Maria alle Scotte, Siena, Italy; 3 Azienda Ospedaliera San G. Moscati, Avellino, Italy; 4 Istituti Ospitalieri di Cremona, Cremona, Italy; 5 Ospedale Maresca, Torre del Greco, Italy; 6 Ospedale Valduce, Como, Italy Background and Aim: Precut technique is a validated risk factor for post-ERCP pancreatitis (PEP). However, it is unclear if the risk is associated with technique or with difficult papillary cannulation that anticipates precut. The aim of this study was to evaluate the success and complication rates of early precutting and standard cannulation to access to the common bile duct. Material and methods: Over a 7-month period (January-July 2011) in 6 Italian centers patients referred for therapeutic biliary ERCP were considered for inclusion in the study. In case of difficult biliary cannulation (failed cannulation after 5 minutes or 3 cannulations of the main pancreatic duct, MPD) patients were included in the study and randomized in 2 groups: 1. early precut (EP); 2. standard cannulation (SC) for other 10 minutes or 3 further cannulations of the MPD followed, in case of failed cannulation, by late precut or interruption of ERCP. Results: In a 7- month period 563 patients undergone ERCP for biliary disease. 99 patients with difficult cannulation were included in the study, 49 randomized to EP and 50 to SC. The two groups were homogeneous for age, gender and clinical risk factors. The overall biliary cannulation success rate was 90.9% (90/99 patients): 91.8% in EP group and 88% in SC group (p0.53). However, in the 10 minutes after randomization, the success rate was statistically different between the two groups (91.8% in EP and 26% in SC) (p0.0001). Overall complication rate was 18.2%, PEP in 16 cases (16.2%), bleeding and cholangitis in one case. While overall complication rate was significantly higher in SC than EP group (26% vs 10.2%), PEP was not (22% vs 10.2%; p0.11). Three patients, all in the SC group, developed severe PEP. Conclusions: Early precut appears a safe and feasible approach in case of difficult biliary cannulation. The study is still ongoing and further patients are needed to confirm this data. 449 Blood Urea Nitrogen as a Predictor of Development of Post- Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Case- Control Study Tatyana Kushner*, Nazanin Majd, Keith Sigel, Mitchell L. Liverant, Serre-Yu Wong, Kalpesh K. Patel, Susana Gonzalez Internal Medicine, Mount Sinai Medical Center, New York, NY Background: Pancreatitis is the most common complication of Endoscopic Retrograde Cholangiopancreatography (ERCP), occurring after 1-30% of procedures and associated with significant morbidity and mortality. Although several patient characteristics and procedural characteristics have been established as known risk factors for development of Post-ERCP Pancreatitis (PEP), these do not account for all cases. Early changes in blood urea nitrogen (BUN) are known to predict mortality in acute pancreatitis from any cause. We performed a case-control study to determine if elevated BUN prior to ERCP is a risk factor for the development of PEP. Method: 1757 patients who had undergone ERCPs at Mount Sinai Medical Center from August 2005 to September 2011 were identified in our electronic clinical data repository. Patients with serum amylase levels 900 (3 times the upper limit of normal) after ERCP were identified as potential cases. Patient discharge summaries were reviewed to confirm PEP and patients with pancreatitis prior to ERCP were then excluded. Depending on availability of eligible controls, either one or two age- and gender-matched controls were then selected from the remaining ERCP cases. Data was then collected from the clinical record on all cases and controls including patient demographics, indications for procedure, pre-procedure BUN, and bilirubin and established procedural risk factors for PEP. These variables were then compared between cases and controls. We then evaluated the association of demographics, known risk factors for PEP, and our exposure of interest, BUN, on the outcome of PEP in a conditional logistic regression model. Results: Of the 1757 patients who underwent ERCPs, 111 cases of PEP were identified (6%). In comparison to 160 age and gender matched controls, patients with PEP were more likely to have undergone sphincterotomy including precut, pancreatic, and minor papilla sphincterotomy (46% vs. 22%; p0.001) and had lower mean total bilirubin (6.1mg/dl vs. 17 mg/dl; p0.001). In our unadjusted analysis, there was no association between elevated BUN and PEP. However, after adjustment for race, sphincterotomy, previous pancreatitis, and bilirubin, we found BUN to be associated with increased risk of PEP (Table 1; odds ratio 5.0; 95% confidence interval 1.4-18.3). Conclusion: In this case-control study of PEP cases at our institution, elevated BUN was found to be associated with an Abstracts AB141 GASTROINTESTINAL ENDOSCOPY Volume 75, No. 4S : 2012 www.giejournal.org

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High Volume Endoscopist (HVE) vs Low Volume Endoscopist (LVE)

Parameter

HVEN�253

Mean(S.D.)LVE N�78Mean(S.D.) % change p-value

Dose Area Product (Gycm^2) 11.32 (9.18) 21.26 (23.54) HVE 47% lower P�0.0001Effective Dose (mSv) 2.12 (2.49) 4.29 (6.3) HVE 50% lower P�0.0001Fluoro Time (minutes) 4.3 (3.28) 5.56 (6.22) HVE 23% lower P�0.05Procedure Complexity 2.37 (0.76) 1.99 (0.61) HVE 19% higher P�0.0001Fluoro Complexity 4.91 (1.92) 3.63 (1.31) HVE 35% higher P�0.0001DAP/Procedure Complexity 5.05 (4.11) 10.6 (10.67) HVE 52% lower P�0.0001DAP/Fluoro Complexity 2.62 (2.62) 5.89 (5.22) HVE 56% lower P�0.0001

Fluoroscopy Complexity Score

CATEGORY SCORE

CBD cannulation 1PD cannulation 1sphincterotomy 1non hilar stricture 1hilar stricture 2dilation 1brushing 1stone balloon sweep 1stone basket sweep 1Lithotripsy, mechanical or EHL 1choledochoscopy 1stent (metal or plastic) 1biopsy 1prior stent 1whipple or billroth 2 1

447DGT vs TPS in Patients With Initial PD Cannulation by Chance;Prospective Randomized Multi-Center StudySang-Woo Cha*1, Sae Hee Kim2, Anna Kim2, Eun Taek Park3,Kyo-Sang Yoo4, Moo in Park3, Seun Ja Park3, Young Deok Cho1

1Institute for Digestive Research, Digestive Disease Center,Soonchunhyang University College of Medicine, Seoul, Republic ofKorea; 2Department of Internal Medicine, Eulji University Hospital,Deajeon, Republic of Korea; 3Department of Internal Medicine, KosinUniversity Gospel Hospital, Busan, Republic of Korea; 4Departmemt ofInternal Medicine, Hallym University Sacred Heart Hospital, Anyang,Republic of KoreaBackground/Aim: Successful cannulation of the common bile duct (CBD) is animportant benchmark of ERCP. Repeated cannulation for CBD is one of the mainrisk factors for post-ERCP pancreatitis. Recently, pancreatic duct guidewireassisting bile duct cannulation (double guidewire technique, DGT) ortranspancreatic precut sphincterotomy (TPS) have been considered a promisingalternative approach in difficult cannulation situations. The aim of this study wasto compare the performance of DGT with the TPS in the patients in whompancreatic duct cannulation was performed initially. Patients/Methods: Whenguidewire was placed in the pancreatic duct by chance, the patients were thenrandomized into DGT or TPS groups. After this, bile duct cannulation was retriedusing DGT or TPS. Main outcome measurements were frequency of successfulCBD cannulation and post-procedure related complications. Results: The groupswere similar with regard to patient demographics. A total of 81 patients wereenrolled. 39 patients were assigned to the DGT group and 42 to the TPS.Successful CBD cannulation was achieved in 31 (79.5%) of 39 patients in theDGT group and 39 (92.9%) of 42 patients in the TPS group. The meancannulation time was 19.7 minutes in the DGT group and 15 minutes in the TPSgroup (P � 0.054). There was no significant difference in the successful CBDcannulation rate or mean cannulation time after p-duct cannulation between twogroups. The overall incidence of post-procedure pancreatitis was 12.8% (5/39) inthe DGT group, and 11.9% (5/42) in the TPS group. Post-procedurehyperamylasemia was significantly higher in DGT group (P � 0.033).Conclusion: In patients with pancreatic duct cannulation initially by chance, DGTand TPS facilitate biliary cannulation and show the similar success rates. Theincidence of post-procedure pancreatitis was similar in the two groups, but post-procedure hyperamylasemia was significantly higher in the DGT group.

448A Prospective Randomized Multicenter Trial Comparing EarlyPrecut and Standard Approach for Cannulating the CommonBile Duct: An Interim AnalysisAlberto Mariani*1, Antonella Giussani1, Milena Di Leo1, Mario Marini2,Nicola Giardulllo3, Federico Buffoli4, Maria Antonia Bianco5,Vittorio Terruzzi6, Pier Alberto Testoni11Vita-Salute San Raffaele University, Scientific Institute San Raffaele,Milan, Italy; 2Azienda Ospedaliera Università Senese, Policlinico SantaMaria alle Scotte, Siena, Italy; 3Azienda Ospedaliera San G. Moscati,Avellino, Italy; 4Istituti Ospitalieri di Cremona, Cremona, Italy;5Ospedale Maresca, Torre del Greco, Italy; 6Ospedale Valduce, Como,ItalyBackground and Aim: Precut technique is a validated risk factor for post-ERCPpancreatitis (PEP). However, it is unclear if the risk is associated with techniqueor with difficult papillary cannulation that anticipates precut. The aim of thisstudy was to evaluate the success and complication rates of early precutting andstandard cannulation to access to the common bile duct. Material and methods:Over a 7-month period (January-July 2011) in 6 Italian centers patients referredfor therapeutic biliary ERCP were considered for inclusion in the study. In caseof difficult biliary cannulation (failed cannulation after 5 minutes or 3cannulations of the main pancreatic duct, MPD) patients were included in thestudy and randomized in 2 groups: 1. early precut (EP); 2. standard cannulation(SC) for other 10 minutes or 3 further cannulations of the MPD followed, in caseof failed cannulation, by late precut or interruption of ERCP. Results: In a 7-month period 563 patients undergone ERCP for biliary disease. 99 patients withdifficult cannulation were included in the study, 49 randomized to EP and 50 toSC. The two groups were homogeneous for age, gender and clinical risk factors.The overall biliary cannulation success rate was 90.9% (90/99 patients): 91.8% inEP group and 88% in SC group (p�0.53). However, in the 10 minutes afterrandomization, the success rate was statistically different between the two groups(91.8% in EP and 26% in SC) (p�0.0001). Overall complication rate was 18.2%,PEP in 16 cases (16.2%), bleeding and cholangitis in one case. While overallcomplication rate was significantly higher in SC than EP group (26% vs 10.2%),PEP was not (22% vs 10.2%; p�0.11). Three patients, all in the SC group,developed severe PEP. Conclusions: Early precut appears a safe and feasibleapproach in case of difficult biliary cannulation. The study is still ongoing andfurther patients are needed to confirm this data.

449Blood Urea Nitrogen as a Predictor of Development of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis:A Case- Control StudyTatyana Kushner*, Nazanin Majd, Keith Sigel, Mitchell L. Liverant,Serre-Yu Wong, Kalpesh K. Patel, Susana GonzalezInternal Medicine, Mount Sinai Medical Center, New York, NYBackground: Pancreatitis is the most common complication of EndoscopicRetrograde Cholangiopancreatography (ERCP), occurring after 1-30% ofprocedures and associated with significant morbidity and mortality. Althoughseveral patient characteristics and procedural characteristics have beenestablished as known risk factors for development of Post-ERCP Pancreatitis(PEP), these do not account for all cases. Early changes in blood urea nitrogen(BUN) are known to predict mortality in acute pancreatitis from any cause. Weperformed a case-control study to determine if elevated BUN prior to ERCP is arisk factor for the development of PEP. Method: 1757 patients who hadundergone ERCPs at Mount Sinai Medical Center from August 2005 to September2011 were identified in our electronic clinical data repository. Patients withserum amylase levels � 900 (3 times the upper limit of normal) after ERCP wereidentified as potential cases. Patient discharge summaries were reviewed toconfirm PEP and patients with pancreatitis prior to ERCP were then excluded.Depending on availability of eligible controls, either one or two age- andgender-matched controls were then selected from the remaining ERCP cases.Data was then collected from the clinical record on all cases and controlsincluding patient demographics, indications for procedure, pre-procedure BUN,and bilirubin and established procedural risk factors for PEP. These variableswere then compared between cases and controls. We then evaluated theassociation of demographics, known risk factors for PEP, and our exposure ofinterest, BUN, on the outcome of PEP in a conditional logistic regression model.Results: Of the 1757 patients who underwent ERCPs, 111 cases of PEP wereidentified (6%). In comparison to 160 age and gender matched controls, patientswith PEP were more likely to have undergone sphincterotomy including precut,pancreatic, and minor papilla sphincterotomy (46% vs. 22%; p�0.001) and hadlower mean total bilirubin (6.1mg/dl vs. 17 mg/dl; p�0.001). In our unadjustedanalysis, there was no association between elevated BUN and PEP. However,after adjustment for race, sphincterotomy, previous pancreatitis, and bilirubin, wefound BUN to be associated with increased risk of PEP (Table 1; odds ratio 5.0;95% confidence interval 1.4-18.3). Conclusion: In this case-control study of PEPcases at our institution, elevated BUN was found to be associated with an

Abstracts

AB141 GASTROINTESTINAL ENDOSCOPY Volume 75, No. 4S : 2012 www.giejournal.org