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Su1649 Algorithmic Approach Including Bile Aspiration to Decrease ERCP Associated Adverse Events in Primary Sclerosing Cholangitis
Abstracts Su1646 Endoscopic Treatment of Dominant Biliary Strictures in Primary Sclerosing Cholangitis Patients: Comparison of Adverse Events Associated With Balloon Dilation With and Without Stenting Udayakumar Navaneethan1,2, Ramprasad Jegadeesan*1, Jeffrey Hammel1, Madhusudhan R. Sanaka1, John J. Vargo1, Mansour A. Parsi1 1 Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH; 2Cleveland2Center for Interventional Endoscopy, Florida Hospital Institute for Minimally Invasive Therapy, Orlando, FL Background: Dominant biliary strictures occur commonly in patients with primary sclerosing cholangitis (PSC). The optimal endoscopic management of dominant strictures remains unclear and the comparative risk of adverse events associated with balloon dilation alone versus balloon dilation and short term stenting remains unknown. Aim: Our aim was to compare the rate of adverse events associated with balloon dilation alone versus balloon dilation followed by short term stenting (! 7 days) in PSC patients with dominant strictures. Methods: In this retrospective study, 298 patients with PSC were evaluated. Among these, patients who had undergone biliary balloon dilation and/or short term stent placement (! 7 days) for endoscopic treatment of dominant strictures were identified. Adverse events associated with endoscopic biliary balloon dilatation with and without short term stenting for management of dominant strictures were determined. Results: A total of 72 PSC patients (median age 52.6 years; interquartile range 42.5-64) with dominant strictures were identified. Fifteen patients (20.8%) were treated with endoscopic balloon dilation alone and 57 patients (79.2%) were treated with balloon dilation and stent placement. Both groups had comparable baseline characteristics such as age, symptoms, bilirubin levels and severity of PSC as determined by the Mayo PSC risk score. The median duration of follow-up after intervention was similar in both groups (49 months). The overall risk of adverse events with endoscopic retrograde cholangiopancreatography (ERCP) was 15.3% (nZ11). Six patients developed cholangitis which was the most common adverse event. None of the patients in the balloon dilation alone group developed adverse events in contrast to 19.3% of patients (nZ11) who had undergone balloon dilation and short term stenting. (p! 0.01) On multivariate analysis, only stent placement increased the risk of adverse event development. (Hazard ratio 1.86; 95% confidence interval [1.3-2.2], pZ0.02). Conclusions: In this study, even short term stenting after balloon dilation appeared to increase the overall risk of adverse events associated with treatment of dominant strictures in PSC patients. Randomized controlled trials are required to clarify the appropriate management of dominant strictures in PSC patients.
Su1647 Endoscopic Management of Bile Duct Calculi in Patients With Primary Sclerosing Cholangitis Ramprasad Jegadeesan*1, Udayakumar Navaneethan1,2, Vennisvasanth Lourdusamy1, Jeffrey Hammel1, Madhusudhan R. Sanaka1, John J. Vargo1, Mansour A. Parsi1 1 Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH; 2Center for Interventional Endoscopy, Florida Hospital Institute for Minimally Invasive Therapy, Orlando, FL Background: Endoscopic management of bile duct stones in patients with primary sclerosing cholangitis (PSC) can be challenging because strictured ducts. Aim: Our aim was to report the efficacy and safety of endoscopic treatment of bile duct stones in PSC patients. Methods: Patients with PSC who underwent attempted endoscopic removal of bile duct stones from 2001 to 2013 were identified retrospectively. Clinical parameters, endoscopic data, and outcomes were collected, analyzed and compared to PSC patients who had ERCP without stones. Results: 58 PSC patients had undergone endoscopic treatments for choledocholithiasis. These patients were compared to 240 PSC patients who did not have stones on ERCP during the same time period. The basic demographic information was similar in both groups. Precut sphincterotomy was required to achieve cannulation in 14 patients [13 patients without stones (5.5%) and 1 patient with stones (1.7%)]. Stones were multiple in 56/ 58 patients (96.6%). Among the 58 patients with choledocholithiasis, 52 patients had stones only in the extrahepatic ducts, 2 only in the intrahepatic ducts and 4 patients in both intra and extrahepatic ducts. Complete stone removal was accomplished in all 52 patients (89.7%) with extrahepatic duct stones. Partial removal of stones was possible in all 4 patients with intrahepatic and extrahepatic stones, while stone removal was not possible in both patients with intrahepatic stones. Presence of intrahepatic stones correlated with failure of endoscopic removal (p!.001), while presence of a stricture below the stone did not affect stone removal. Stone removal was accomplished by sphincterotomy and balloon extraction in 50 patients while 2 patients required basket for stone extraction. Post-ERCP adverse events were observed in 18/298 patients (6%). The adverse event rate was not significantly different between the two groups. (6.7% in the group without stones vs. 3.4% in the group with stone removal; pZ0.54). On multivariate analysis, passage of a guidewire into the pancreatic duct [OR- 3.81, 95% CI (1.02 - 14.3), p- 0.04] was the only factor associated with an increased risk of adverse event development. Stone removal at ERCP [OR- 0.61, 95% CI (0.13 - 2.80)] was not associated with increased risk of
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adverse event. Conclusions: Bile duct stones are commonly seen in patients with PSC. Endoscopic removal of extrahepatic stones can be accomplished with standard equipment and technique in nearly all cases. Presence of intrahepatic stones is associated with higher rate of removal failure by endoscopic techniques. In patients with PSC, stone removal during ERCP is not associated with increased risk of adverse events.
Su1648 ERCP in the Evaluation of Suspected Biliary Complications After Liver Transplantation: Predictors of Success Iris Lee*, Mark Flasar, Lance T. Uradomo, Peter Darwin, Eric M. Goldberg Gastroenterology & Hepatology, University of Maryland Medical Center, Baltimore, MD Background: Biliary complications are among the most common complications after liver transplantation and remain a major source of morbidity in as many as 32% of patients. These complications are more frequent due to increases in liver transplantation, an expanding pool of living donors, as well as prolonged survival of transplant recipients. Elevated liver biochemistries are commonly seen in the weeks to years following transplantation for various reasons including acute and chronic rejection, recurrent viral hepatitis, ischemic hepatitis and drug-induced liver injury. However, because post-transplantation biliary complications are so frequent, ERCP is often used as an initial diagnostic and therapeutic test with varying success. The initial efficacy of ERCP in suspected biliary complications after transplantation has yet to be determined. Specific Aim: To determine the efficacy of ERCP for the diagnosis and treatment of abnormal LFTs after transplantation and to identify predictors of successful endoscopic treatment of suspected biliary complications. Methods: Chart review was performed on adult patients who underwent liver transplantation and subsequent ERCP at the University of Maryland Medical Center between August 1st 2003 and March 31st2014. Results: Technical success, defined as ability to cannulate the bile duct, was achieved in 144 of 146 patients (98.6%). Endoscopic success was defined as improvement of LFTs and/or resolution of strictures or leak. The overall endoscopic success rate of ERCPs in the initial evaluation of abnormal LFTs or imaging was 46%. Factors which are positively correlated with endoscopic success included: biliary leak (p Z 0.02, RR Z 1.55, 95% CI 1.12.1), anastomotic strictures (p Z 0.0002, RR Z 1.53, 95% CI 1.2-1.9) and transplantation for alcoholic liver disease or hepatocellular carcinoma (p Z 0.02, RR 1.46, 95% CI 1.1-1.9 and p Z 0.02, RR 1.48, 95% CI 1.1 - 1.9 respectively). Shorter transplant-to-ERCP interval was seen in patients with endoscopic success (230 vs. 360 days; pZ0.03) as was shorter transplantation cold ischemic time (267 vs. 310 minutes; pZ0.01). Factors which are negatively correlated with endoscopic success included abnormal MRCP and non-anastomotic strictures. Liver biopsy pathology did not correlate with endoscopic success, regardless of findings suggestive of biliary obstruction. Conclusion: In patients presenting with abnormal LFTs post-transplantation, ERCP will diagnose less than half with biliary pathology that will respond to endoscopic therapy. Liver biopsy findings suggestive of cholestasis or MRCP findings suggestive of biliary obstruction do not correlate positively with response to endoscopic therapy. Further studies are needed to determine where ERCP fits in the diagnostic algorithm of post-transplant patients with potential biliary complications.
Su1649 Algorithmic Approach Including Bile Aspiration to Decrease ERCP Associated Adverse Events in Primary Sclerosing Cholangitis Udayakumar Navaneethan*1,2, Vennisvasanth Lourdusamy1, Ramprasad Jegadeesan1, Madhusudhan R. Sanaka1, Jeffrey Hammel1, John J. Vargo1, Mansour A. Parsi1 1 Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH; 2Cleveland2Center for Interventional Endoscopy, Florida Hospital Institute for Minimally Invasive Therapy, Orlando, FL Background: ERCP is frequently used in patients with primary sclerosing cholangitis (PSC) for cancer surveillance and treatment of dominant strictures. Safety of ERCP in PSC patients is a concern with increased risk of cholangitis with biliary interventions. Our aim was to validate an algorithmic approach to ERCP interventions with the objective of decreasing adverse events. Methods: In patients undergoing ERCP for PSC, phase I was a retrospective analysis of ERCP performed in 156 PSC patients from 2005-2012. Bile aspiration was not performed and contrast was injected once biliary cannulation was achieved with wire guided cannulation. At phase I, the overall adverse events was rate was 10.3%. Based on these observations, an algorithm was proposed by which bile aspiration was performed prior to contrast injection in all patients undergoing ERCP for PSC. This algorithm was tested prospectively in phase II on 46 patients from 2012-2014. Akaike’s information criterion was used to build a stepwise model with bile aspiration and PSC severity forced as covariates. The main outcome measurements were procedural adverse events. Results: The risk of overall
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Abstracts
adverse events rate and cholangitis risk was relatively less in phase II compared with that of phase I [(4.3% vs 10.3%; P Z .38) and (2.2% vs 4.5%; P Z .68)] respectively. On multivariate analysis for overall adverse events, only biliary sphincterotomy (odds ratio [OR] 5.04; 95% confidence interval [CI], 2.01-12.60; P Z .001) was associated with increased risk of adverse events. Bile aspiration prior to contrast injection did not impact the overall risk. (OR 0.51 (0.11 - 2.51); PZ .41). On multivariate analysis for development of cholangitis, only biliary stent placement (odds ratio [OR] 10.9; 95% confidence interval [CI], 1.3-92.7; P Z .03) was associated with increased risk of cholangitis. Although there was a trend, bile aspiration prior to contrast injection did not impact the overall risk of cholangitis. (OR 0.33 (0.04 - 2.87); PZ .32). Conclusion: An algorithmic approach to ERCP in PSC patients including bile aspiration is associated with a trend towards a decrease in the risk of overall adverse events and cholangitis. A larger sample size is required to reliably detect smaller differences.
Su1650 Combined Biochemical and Clinical Markers in Bile Duct Obstruction: Novel Score for Prediction of Bile Duct Malignancy Dirk Domagk*1, Tobias Meister1,4, Maria-Anna Uphoff1, Achim Heinecke2, Steffen Kunsch3, Alexander Lindhorst3, Volker Ellenrieder3, Hauke Heinzow1 1 Department of Medicine B, University of Muenster, Muenster, Germany; 2 Institute of Biometrics and Clinical Research, University of Muenster, Muenster, Germany; 3Department of Gastroenterology II, University Medical Center Göttingen, Goettingen, Germany; 4Department of Gastroenterology, HELIOS Albert-Schweitzer Hospital, Göttingen University Teaching Hospital, Northeim, Germany Background: Early identification of malignant bile duct obstruction is very important for the further clinical course. Aim: We aimed to identify clinical and biochemical predictors for malignancy in patients with bile duct obstruction and developed a novel predictive score by combining well-established pre-treatment patient characteristics. Methods: A patient cohort of 1135 patients (median age 66 [ 52-75] years, 53% male) with bile duct obstruction of various etiology was retrospectively evaluated at an academic tertiary referral center (University of Muenster, Germany). Multivariate logistic regression analysis was performed to identify independent risk factors for malignant bile duct obstruction. A predictive risk score derived from four predictors was established using ROC analysis and applied to an external validation cohort of 102 patients from another academic tertiary referral center (University of Goettingen, Germany). Results: Malignant bile duct obstruction, proven by surgery, was found in 394 patients while in 741 patients benign obstruction was observed. Multivariate analysis identified various clinical factors to be positive predictive for malignancy. On the basis of the four predictors age, bilirubin, g-glutamyltransferase and diabetes, a risk score for malignancy was developed (XZ0.165*[Bilirubin]+ 0.001*[g-GT] +0.028*[age]+0.578*[1 if diabetes, otherwise 0]-4.121): A significant correlation between the predicted malignancy and the actual malignancy was found by ROC analysis (AUC: 0.841; 95%CI 0.816-0.865, p!0.0001. The results were validated at an other independent tertiary referral center (AUC:0.683; 95%CI 0.5810.786, pZ0.002). Conclusions: This novel predictive risk score for estimating the risk of malignancy in patients with bile duct obstruction seems to be very accurately. An easily assesed and reliable prediction enables both earlier diagnosis of malignant bile duct obstruction and might improve management in these patients.
Su1651 Clinical Evaluation of Tokyo Guidelines 2013 for Severity Assessment of Acute Cholangitis Takayoshi Nishino*, Tetsuya Hamano, Izumi Shirato, Yutaka Mitsunaga, Miho Shirato, Masahiko Shimada, Shuhei Yoshida, Maki Tobari, Motoyasu Kan, Atsushi Mitsunaga Dept of Gastroenterology, Tokyo Women’s Medical University, Yachiyo Medical Center, Chiba, Japan Background and Aim: The Tokyo guidelines 2013 (TG13) provide new severity assessment criteria for acute cholangitis (AC) that clearly differentiate between moderate AC and mild AC so as not to miss the optimal timing for biliary drainage. The aim of the study was to evaluate the severity assessment criteria for AC of TG13 and developed a scoring system for predicting the need for urgent/early biliary
www.giejournal.org
drainage. Methods: We retrospectively reviewed 66 consecutive AC cases (M:FZ39:27, average age 72 years old) prospectively managed based on the TG07 and divided into an urgent/early biliary drainage group (nZ30) and elective biliary drainage group (nZ36).When the diagnosis was severe AC (nZ13), we performed urgent biliary drainage as soon as possible (within 12h). When a patient initially diagnosis with less severe than AC developed SIRS and/or SIRS persisted despite the initial medical treatment, we performed early biliary drainage (within 24h, nZ17). Results: 1.There were 26 mild, 27 moderate, and 13 severe cases in based on the TG13. TG13 assessment in 12 of the 17 cases requiring early biliary drainage based on the TG07 was moderate AC, but underestimated the other five cases as mild AC. 2. When five predictors were used to devise a scoring system (maximum sore possible: 8 points) in which 2 points each were assigned for BUN O20 mg/dL, the presence of SIRS, and a platelet count ! 120,000/mL which were identified by multivariate analysis as statistically significant factors and 1 point each for serum albumin !3.0g/dL and age S 75 years old, which were identified by univariate analysis alone as statistically significant factors, the receiver-operator characteristic curve of the scores showed good test performance for predicting the need for urgent/early biliary drainage. The area under the curve (AUC) of the proposed score was 0.95 (95%CI; 0.86-0.99) and statistically significantly higher than the severity assessment criteria for AC of TG13 (0.80: 95%CI; 0.68-0.89)(pZ0.004).3. The optimal cut-off value was 4 points, which yielded a sensitivity of 73.3% and specificity of 97.2%. Conclusions: The TG13 is practical, but some AC cases requiring urgent/ early biliary drainage were underestimated as mild AC. The scoring system allows identification of high-risk AC patients and will improve the TG13.
Su1652 Forward-Viewing Colonoscopy Versus Full-Spectrum Endoscopy (Fuse) for Dysplasia Detection With and Without Chromoendoscopy in Inflammatory Bowel Diseases: a Prospective, Randomized-Order, Crossover Tandem Surveillance Colonoscopy Study Marie Ooi*, Crispin Corte, Rupert W. Leong Gastroenterology, Concord Hospital, Sydney, NSW, Australia Background: Traditional forward-viewing colonoscopy (FVC) is impeded by a narrow field of view of !170 with adenoma “miss-rates” of 24-42%. This limitation impairs dysplasia surveillance in chronic colitis.Chromoendoscopy improves visualisation of dysplasia but has never been used with FUSE, which provides 330 visualisation. This study compares FVC and FUSE with and without chromoendoscopy for the identification of dysplasia in IBD. Methods: This was a prospective, randomized-order, crossover tandem colonoscopy trial at an academic IBD centre. Inclusion criteria were left sided or extensive colitis for O10 years disease duration, primary sclerosing cholangitis (PSC) or previous dysplasia. Patients underwent same-day, backto-back tandem colonoscopy with FVC (PCF/CF 180/190, Olympus, Japan) and the FUSE colonoscope (EndoChoice, USA) under propofol sedation.Order randomization was computer-generated. Patients and endoscopist were masked to group allocation until immediately prior to colonoscopy. All lesions detected during initial colonoscopy were removed and any additional lesions detected on subsequent colonoscopy were thenremoved. Chromoendoscopy (CE) was with methylene blue dye spray,additionalrandom biopsies wereperformed during the second colonoscopy. The primary endpoint was dysplasia-yield. The secondary endpoint was detection of dysplasia on random biopsy versus CE-targeted biopsies. Logistic regression and Chi square statistics were performed. Results: 24 were randomized (16 males, mean age 37 yr, Crohn’s colitis nZ16, ulcerative colitis nZ8, mean duration of colitis: 13.5 years). Two subjects had prior low-grade dysplasia and two had primary sclerosing cholangitis. Ileal-intubation rate was 100%. 46% were randomized to FVC first and 54% to FUSE first. All had cross-over CE as the second procedure.Ona per-lesion analysis for lesion detection, FUSE OR was 4.86 (95% CI: 1.43-16.49) vs FVC OR: 2.33 (95% CI: 0.74-7.13; P!0.01) .Dysplasia detection with FUSE had an OR: 7.67 (95% CI: 9.85-69.6) vs FVC OR:2.90 (95% CI: 0.50-16.67). Combined hyperplastic/dysplasia detection with FUSE had an OR: 3.80 (95% CI: 1.07-13.52) vs FVC OR: 1.74 (95% CI 0.52-5.74). The mean lesion detection with FUSE vs FVC was 1.62 vs 0.45 (P!0.042), with mean dysplasia detection of 0.30 vs 0.09 respectively (PZ0.21). FUSE +/- CE vs FVC +/- CE had a mean dysplasia detection of 0.25 vs 0.04 (PZ0.04) andmean lesion detection of 2.25 vs 0.67 respectively (PZ0.003). Mean caecal intubation timesfor FUSE and FVC were 4.7 and 4.6 minutes respectively (ns). Dysplasia yield on targeted biopsies with CE yield was 10.8% vs 0% on random biopsies (P!0.0001). Conclusions: FUSE significantly increased dysplasia identification in IBD surveillance. We confirmed the dysplasia yield of random biopsies in the setting of IBD is very low.
Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB365
Su1647 Endoscopic Management of Bile Duct Calculi in Patients With Primary Sclerosing Cholangitis Ramprasad Jegadeesan*1, Udayakumar Navaneethan1,2, Vennisvasanth Lourdusamy1, Jeffrey Hammel1, Madhusudhan R. Sanaka1, John J. Vargo1, Mansour A. Parsi1 1 Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH; 2Center for Interventional Endoscopy, Florida Hospital Institute for Minimally Invasive Therapy, Orlando, FL Background: Endoscopic management of bile duct stones in patients with primary sclerosing cholangitis (PSC) can be challenging because strictured ducts. Aim: Our aim was to report the efficacy and safety of endoscopic treatment of bile duct stones in PSC patients. Methods: Patients with PSC who underwent attempted endoscopic removal of bile duct stones from 2001 to 2013 were identified retrospectively. Clinical parameters, endoscopic data, and outcomes were collected, analyzed and compared to PSC patients who had ERCP without stones. Results: 58 PSC patients had undergone endoscopic treatments for choledocholithiasis. These patients were compared to 240 PSC patients who did not have stones on ERCP during the same time period. The basic demographic information was similar in both groups. Precut sphincterotomy was required to achieve cannulation in 14 patients [13 patients without stones (5.5%) and 1 patient with stones (1.7%)]. Stones were multiple in 56/ 58 patients (96.6%). Among the 58 patients with choledocholithiasis, 52 patients had stones only in the extrahepatic ducts, 2 only in the intrahepatic ducts and 4 patients in both intra and extrahepatic ducts. Complete stone removal was accomplished in all 52 patients (89.7%) with extrahepatic duct stones. Partial removal of stones was possible in all 4 patients with intrahepatic and extrahepatic stones, while stone removal was not possible in both patients with intrahepatic stones. Presence of intrahepatic stones correlated with failure of endoscopic removal (p!.001), while presence of a stricture below the stone did not affect stone removal. Stone removal was accomplished by sphincterotomy and balloon extraction in 50 patients while 2 patients required basket for stone extraction. Post-ERCP adverse events were observed in 18/298 patients (6%). The adverse event rate was not significantly different between the two groups. (6.7% in the group without stones vs. 3.4% in the group with stone removal; pZ0.54). On multivariate analysis, passage of a guidewire into the pancreatic duct [OR- 3.81, 95% CI (1.02 - 14.3), p- 0.04] was the only factor associated with an increased risk of adverse event development. Stone removal at ERCP [OR- 0.61, 95% CI (0.13 - 2.80)] was not associated with increased risk of
AB364 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
adverse event. Conclusions: Bile duct stones are commonly seen in patients with PSC. Endoscopic removal of extrahepatic stones can be accomplished with standard equipment and technique in nearly all cases. Presence of intrahepatic stones is associated with higher rate of removal failure by endoscopic techniques. In patients with PSC, stone removal during ERCP is not associated with increased risk of adverse events.
Su1648 ERCP in the Evaluation of Suspected Biliary Complications After Liver Transplantation: Predictors of Success Iris Lee*, Mark Flasar, Lance T. Uradomo, Peter Darwin, Eric M. Goldberg Gastroenterology & Hepatology, University of Maryland Medical Center, Baltimore, MD Background: Biliary complications are among the most common complications after liver transplantation and remain a major source of morbidity in as many as 32% of patients. These complications are more frequent due to increases in liver transplantation, an expanding pool of living donors, as well as prolonged survival of transplant recipients. Elevated liver biochemistries are commonly seen in the weeks to years following transplantation for various reasons including acute and chronic rejection, recurrent viral hepatitis, ischemic hepatitis and drug-induced liver injury. However, because post-transplantation biliary complications are so frequent, ERCP is often used as an initial diagnostic and therapeutic test with varying success. The initial efficacy of ERCP in suspected biliary complications after transplantation has yet to be determined. Specific Aim: To determine the efficacy of ERCP for the diagnosis and treatment of abnormal LFTs after transplantation and to identify predictors of successful endoscopic treatment of suspected biliary complications. Methods: Chart review was performed on adult patients who underwent liver transplantation and subsequent ERCP at the University of Maryland Medical Center between August 1st 2003 and March 31st2014. Results: Technical success, defined as ability to cannulate the bile duct, was achieved in 144 of 146 patients (98.6%). Endoscopic success was defined as improvement of LFTs and/or resolution of strictures or leak. The overall endoscopic success rate of ERCPs in the initial evaluation of abnormal LFTs or imaging was 46%. Factors which are positively correlated with endoscopic success included: biliary leak (p Z 0.02, RR Z 1.55, 95% CI 1.12.1), anastomotic strictures (p Z 0.0002, RR Z 1.53, 95% CI 1.2-1.9) and transplantation for alcoholic liver disease or hepatocellular carcinoma (p Z 0.02, RR 1.46, 95% CI 1.1-1.9 and p Z 0.02, RR 1.48, 95% CI 1.1 - 1.9 respectively). Shorter transplant-to-ERCP interval was seen in patients with endoscopic success (230 vs. 360 days; pZ0.03) as was shorter transplantation cold ischemic time (267 vs. 310 minutes; pZ0.01). Factors which are negatively correlated with endoscopic success included abnormal MRCP and non-anastomotic strictures. Liver biopsy pathology did not correlate with endoscopic success, regardless of findings suggestive of biliary obstruction. Conclusion: In patients presenting with abnormal LFTs post-transplantation, ERCP will diagnose less than half with biliary pathology that will respond to endoscopic therapy. Liver biopsy findings suggestive of cholestasis or MRCP findings suggestive of biliary obstruction do not correlate positively with response to endoscopic therapy. Further studies are needed to determine where ERCP fits in the diagnostic algorithm of post-transplant patients with potential biliary complications.
Su1649 Algorithmic Approach Including Bile Aspiration to Decrease ERCP Associated Adverse Events in Primary Sclerosing Cholangitis Udayakumar Navaneethan*1,2, Vennisvasanth Lourdusamy1, Ramprasad Jegadeesan1, Madhusudhan R. Sanaka1, Jeffrey Hammel1, John J. Vargo1, Mansour A. Parsi1 1 Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH; 2Cleveland2Center for Interventional Endoscopy, Florida Hospital Institute for Minimally Invasive Therapy, Orlando, FL Background: ERCP is frequently used in patients with primary sclerosing cholangitis (PSC) for cancer surveillance and treatment of dominant strictures. Safety of ERCP in PSC patients is a concern with increased risk of cholangitis with biliary interventions. Our aim was to validate an algorithmic approach to ERCP interventions with the objective of decreasing adverse events. Methods: In patients undergoing ERCP for PSC, phase I was a retrospective analysis of ERCP performed in 156 PSC patients from 2005-2012. Bile aspiration was not performed and contrast was injected once biliary cannulation was achieved with wire guided cannulation. At phase I, the overall adverse events was rate was 10.3%. Based on these observations, an algorithm was proposed by which bile aspiration was performed prior to contrast injection in all patients undergoing ERCP for PSC. This algorithm was tested prospectively in phase II on 46 patients from 2012-2014. Akaike’s information criterion was used to build a stepwise model with bile aspiration and PSC severity forced as covariates. The main outcome measurements were procedural adverse events. Results: The risk of overall
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Abstracts
adverse events rate and cholangitis risk was relatively less in phase II compared with that of phase I [(4.3% vs 10.3%; P Z .38) and (2.2% vs 4.5%; P Z .68)] respectively. On multivariate analysis for overall adverse events, only biliary sphincterotomy (odds ratio [OR] 5.04; 95% confidence interval [CI], 2.01-12.60; P Z .001) was associated with increased risk of adverse events. Bile aspiration prior to contrast injection did not impact the overall risk. (OR 0.51 (0.11 - 2.51); PZ .41). On multivariate analysis for development of cholangitis, only biliary stent placement (odds ratio [OR] 10.9; 95% confidence interval [CI], 1.3-92.7; P Z .03) was associated with increased risk of cholangitis. Although there was a trend, bile aspiration prior to contrast injection did not impact the overall risk of cholangitis. (OR 0.33 (0.04 - 2.87); PZ .32). Conclusion: An algorithmic approach to ERCP in PSC patients including bile aspiration is associated with a trend towards a decrease in the risk of overall adverse events and cholangitis. A larger sample size is required to reliably detect smaller differences.
Su1650 Combined Biochemical and Clinical Markers in Bile Duct Obstruction: Novel Score for Prediction of Bile Duct Malignancy Dirk Domagk*1, Tobias Meister1,4, Maria-Anna Uphoff1, Achim Heinecke2, Steffen Kunsch3, Alexander Lindhorst3, Volker Ellenrieder3, Hauke Heinzow1 1 Department of Medicine B, University of Muenster, Muenster, Germany; 2 Institute of Biometrics and Clinical Research, University of Muenster, Muenster, Germany; 3Department of Gastroenterology II, University Medical Center Göttingen, Goettingen, Germany; 4Department of Gastroenterology, HELIOS Albert-Schweitzer Hospital, Göttingen University Teaching Hospital, Northeim, Germany Background: Early identification of malignant bile duct obstruction is very important for the further clinical course. Aim: We aimed to identify clinical and biochemical predictors for malignancy in patients with bile duct obstruction and developed a novel predictive score by combining well-established pre-treatment patient characteristics. Methods: A patient cohort of 1135 patients (median age 66 [ 52-75] years, 53% male) with bile duct obstruction of various etiology was retrospectively evaluated at an academic tertiary referral center (University of Muenster, Germany). Multivariate logistic regression analysis was performed to identify independent risk factors for malignant bile duct obstruction. A predictive risk score derived from four predictors was established using ROC analysis and applied to an external validation cohort of 102 patients from another academic tertiary referral center (University of Goettingen, Germany). Results: Malignant bile duct obstruction, proven by surgery, was found in 394 patients while in 741 patients benign obstruction was observed. Multivariate analysis identified various clinical factors to be positive predictive for malignancy. On the basis of the four predictors age, bilirubin, g-glutamyltransferase and diabetes, a risk score for malignancy was developed (XZ0.165*[Bilirubin]+ 0.001*[g-GT] +0.028*[age]+0.578*[1 if diabetes, otherwise 0]-4.121): A significant correlation between the predicted malignancy and the actual malignancy was found by ROC analysis (AUC: 0.841; 95%CI 0.816-0.865, p!0.0001. The results were validated at an other independent tertiary referral center (AUC:0.683; 95%CI 0.5810.786, pZ0.002). Conclusions: This novel predictive risk score for estimating the risk of malignancy in patients with bile duct obstruction seems to be very accurately. An easily assesed and reliable prediction enables both earlier diagnosis of malignant bile duct obstruction and might improve management in these patients.
Su1651 Clinical Evaluation of Tokyo Guidelines 2013 for Severity Assessment of Acute Cholangitis Takayoshi Nishino*, Tetsuya Hamano, Izumi Shirato, Yutaka Mitsunaga, Miho Shirato, Masahiko Shimada, Shuhei Yoshida, Maki Tobari, Motoyasu Kan, Atsushi Mitsunaga Dept of Gastroenterology, Tokyo Women’s Medical University, Yachiyo Medical Center, Chiba, Japan Background and Aim: The Tokyo guidelines 2013 (TG13) provide new severity assessment criteria for acute cholangitis (AC) that clearly differentiate between moderate AC and mild AC so as not to miss the optimal timing for biliary drainage. The aim of the study was to evaluate the severity assessment criteria for AC of TG13 and developed a scoring system for predicting the need for urgent/early biliary
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drainage. Methods: We retrospectively reviewed 66 consecutive AC cases (M:FZ39:27, average age 72 years old) prospectively managed based on the TG07 and divided into an urgent/early biliary drainage group (nZ30) and elective biliary drainage group (nZ36).When the diagnosis was severe AC (nZ13), we performed urgent biliary drainage as soon as possible (within 12h). When a patient initially diagnosis with less severe than AC developed SIRS and/or SIRS persisted despite the initial medical treatment, we performed early biliary drainage (within 24h, nZ17). Results: 1.There were 26 mild, 27 moderate, and 13 severe cases in based on the TG13. TG13 assessment in 12 of the 17 cases requiring early biliary drainage based on the TG07 was moderate AC, but underestimated the other five cases as mild AC. 2. When five predictors were used to devise a scoring system (maximum sore possible: 8 points) in which 2 points each were assigned for BUN O20 mg/dL, the presence of SIRS, and a platelet count ! 120,000/mL which were identified by multivariate analysis as statistically significant factors and 1 point each for serum albumin !3.0g/dL and age S 75 years old, which were identified by univariate analysis alone as statistically significant factors, the receiver-operator characteristic curve of the scores showed good test performance for predicting the need for urgent/early biliary drainage. The area under the curve (AUC) of the proposed score was 0.95 (95%CI; 0.86-0.99) and statistically significantly higher than the severity assessment criteria for AC of TG13 (0.80: 95%CI; 0.68-0.89)(pZ0.004).3. The optimal cut-off value was 4 points, which yielded a sensitivity of 73.3% and specificity of 97.2%. Conclusions: The TG13 is practical, but some AC cases requiring urgent/ early biliary drainage were underestimated as mild AC. The scoring system allows identification of high-risk AC patients and will improve the TG13.
Su1652 Forward-Viewing Colonoscopy Versus Full-Spectrum Endoscopy (Fuse) for Dysplasia Detection With and Without Chromoendoscopy in Inflammatory Bowel Diseases: a Prospective, Randomized-Order, Crossover Tandem Surveillance Colonoscopy Study Marie Ooi*, Crispin Corte, Rupert W. Leong Gastroenterology, Concord Hospital, Sydney, NSW, Australia Background: Traditional forward-viewing colonoscopy (FVC) is impeded by a narrow field of view of !170 with adenoma “miss-rates” of 24-42%. This limitation impairs dysplasia surveillance in chronic colitis.Chromoendoscopy improves visualisation of dysplasia but has never been used with FUSE, which provides 330 visualisation. This study compares FVC and FUSE with and without chromoendoscopy for the identification of dysplasia in IBD. Methods: This was a prospective, randomized-order, crossover tandem colonoscopy trial at an academic IBD centre. Inclusion criteria were left sided or extensive colitis for O10 years disease duration, primary sclerosing cholangitis (PSC) or previous dysplasia. Patients underwent same-day, backto-back tandem colonoscopy with FVC (PCF/CF 180/190, Olympus, Japan) and the FUSE colonoscope (EndoChoice, USA) under propofol sedation.Order randomization was computer-generated. Patients and endoscopist were masked to group allocation until immediately prior to colonoscopy. All lesions detected during initial colonoscopy were removed and any additional lesions detected on subsequent colonoscopy were thenremoved. Chromoendoscopy (CE) was with methylene blue dye spray,additionalrandom biopsies wereperformed during the second colonoscopy. The primary endpoint was dysplasia-yield. The secondary endpoint was detection of dysplasia on random biopsy versus CE-targeted biopsies. Logistic regression and Chi square statistics were performed. Results: 24 were randomized (16 males, mean age 37 yr, Crohn’s colitis nZ16, ulcerative colitis nZ8, mean duration of colitis: 13.5 years). Two subjects had prior low-grade dysplasia and two had primary sclerosing cholangitis. Ileal-intubation rate was 100%. 46% were randomized to FVC first and 54% to FUSE first. All had cross-over CE as the second procedure.Ona per-lesion analysis for lesion detection, FUSE OR was 4.86 (95% CI: 1.43-16.49) vs FVC OR: 2.33 (95% CI: 0.74-7.13; P!0.01) .Dysplasia detection with FUSE had an OR: 7.67 (95% CI: 9.85-69.6) vs FVC OR:2.90 (95% CI: 0.50-16.67). Combined hyperplastic/dysplasia detection with FUSE had an OR: 3.80 (95% CI: 1.07-13.52) vs FVC OR: 1.74 (95% CI 0.52-5.74). The mean lesion detection with FUSE vs FVC was 1.62 vs 0.45 (P!0.042), with mean dysplasia detection of 0.30 vs 0.09 respectively (PZ0.21). FUSE +/- CE vs FVC +/- CE had a mean dysplasia detection of 0.25 vs 0.04 (PZ0.04) andmean lesion detection of 2.25 vs 0.67 respectively (PZ0.003). Mean caecal intubation timesfor FUSE and FVC were 4.7 and 4.6 minutes respectively (ns). Dysplasia yield on targeted biopsies with CE yield was 10.8% vs 0% on random biopsies (P!0.0001). Conclusions: FUSE significantly increased dysplasia identification in IBD surveillance. We confirmed the dysplasia yield of random biopsies in the setting of IBD is very low.
Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB365