Abstracts

141 ampullectomies). Mean tumor size was 2.4 cm (0.5cm to 9cm). ERCP wasperformed prior to all ampullectomies with biliary and pancreatic stentingattempted in all after ampullectomy. Saline lift was only used for lateral extensionand flat lesions. Overall complications from ampullectomy were 20% and included:Mild pancreatitis 13 (11%), cholestasis 1, retroperitoneal perforation 1(adenocarcinoma), intraperitoneal perforation 1 (lateral extension), Bleeding 5(lateral extension 2/5), delayed papillary stenosis 3. Residual adenoma was seen in14 (12%) patients, with recurrences in 8 (7%) patients. The endoscopic success ratewas 87%. Conclusions: 1) Most ampullary adenomas are endoscopically amenable.2) There is a high risk of colonic adenomas and cancers in these patients suggestinga possible need for more frequent colorectal screening. 3) Underlying malignancyand lateral extension are risk factors for bleeding and perforation. 4) Overallcomplication and recurrence rates are favorable compared to surgical resection.

S1508

Effect of Vardenafil, a Phosphodiesterase Type 5 Inhibitor, On

Sphincter of Oddi Motility in Patients with Suspected Sphincter

of Oddi DysfunctionYoung Koog Cheon, Young Deok Cho, Jong Ho Moon, Hee Hyuk Im,Yun Jung, Joon Seong Lee, Moon Sung Lee, Chan Sup ShimBackgrounds/Aim: Both SO stenosis and SO dyskinesia may account for obstructionto flow through the SO and may thus induce retention of bile in the biliary tree andpancreatic juice in the pancreatic duct. The therapeutic approach in patients withSOD is aimed at reducing the resistance caused by the SO to the flow of bile orpancreatic juice. Vardenafil blocks the phosphodiesterase type 5 (PDE-5) enzymethat degrades cyclic guanine monophosphate and, thus, results in relaxation ofsmooth muscle. The aim of this study was to determine the effects of vardenafil onSO motility. Patients and Methods: A consecutive 17 adult patients with suspectedSOD was scheduled to undergo ERCP and SO manometry with aspirating catheter.A basal recording lasting for at least 2 min was obtained at the level of the SO high-pressure zone, identified by station pull-through. A second recording wasperformed in the same position 20 min after vardenafil 10 mg into jejunum throughconventional catheter. Results: After orally administration of vardenafil at a dose 10mg, the mean basal pressure significantly reduced from 60.0 mmHg to 25.2 mmHg(p ! 0.001), and the mean amplitude also significantly reduced from 134.7 mmHgto 63.5 mmHg (p ! 0.001). The mean frequency was significantly changed afteradministration of vardenafil (6.6 vs. 6.1, p Z 0.07). Headache was observed in 1patient, but transient. Procedure related complications were post-ERCP pancreatitis(n Z 2) and hyperamlysemia (n Z 3). Conclusion: Vardenafil has an inhibitoryeffect on sphincter of Oddi (SO) motility in patients with a suspected sphincter ofOddi dysfunction, results in reducing a basal pressure of SO. The current studysuggests a possible therapeutic role for PDE5 inhibitors in the treatment ofhyperfunctional motility disorders of the SO. Prospective, placebo-controlledclinical trials are needed to determine whether PDE-5 inhibitors are effective in thetreatment of SOD and post-ERCP pancreatitis.

S1509

Nafamostat Mesilate for Prevention of Post-ERCP PancreatitisKyo-Sang Yoo, Won Sub Choi, Yong Woo Chung, Kyoung Oh Kim, CheolHee Park, Taeho Hahn, Sang Hoon Park, Jong Hyeok Kim, Jin Lee,Choong Kee ParkBackground: Pancreatitis is the most common major complication of diagnostic andtherapeutic ERCP. Efforts have been made to identify pharmacologic agents capableof reducing its incidence and severity. The aim of this study was to assess theefficacy of prophylactic nafamostat mesilate, a synthetic protease inhibitor, forprevention of post-ERCP pancreatitis. We had presented our data of this study atDDW2007. Additionally, the more patients were additionally enrolled to this studythereafter. Methods: A prospective, double-blind, placebo-controlled trial wasconducted in 273 patients who underwent ERCP. Patients were randomized toreceive nafamostat or placebo. The nafamostat group was treated witha continuous intravenous infusion of 50 mg nafamostat dissolved in 500 mL of 5%dextrose solution, starting 60 minutes before ERCP and continuing for 6 hoursafterward. The placebo group patients were treated only with 500 mL of 5%dextrose solution also starting 60 minutes before ERCP and continuing for 6 hoursafterward. Patients were clinically evaluated, and serum amylase levels weredetermined before ERCP and at 6, 12 and 24 hours thereafter. Standardized criteriawere used to diagnose and to grade the severity of post-ERCP pancreatitis. Results:A total of 273 patients were included in the analysis. The groups were similar withregard to patient demographics, and to patient and procedure risk factors for post-ERCP pancreatitis. The frequency of hyperamylasemia was not significantly differentbetween two groups. The overall incidence of post-ERCP acute pancreatitis was6.2% (17/273). The frequency of acute pancreatitis was lower in the nafamostat vs.the placebo group (p Z 0.05): nafamostat group, 5/143 (3.4%), of which 4/143(2.7%) were graded as mild and 1/143 (0.6%) as moderate, vs. placebo group,12/130 (9.2%), of which 9/130 (6.9%) were graded as mild and 3/130 (2.3%) asmoderate. Conclusions: Prophylactic treatment with nafamostat mesilate decreasesthe frequency of post-ERCP pancreatitis. Further studies involving a large numberof patients are needed to verify these observations of our study.

www.giejournal.org Vo

S1510

Prophylactic Stent Placement for Prevention of Post-ERCP

Pancreatitis: A Meta-AnalysisAbhishek Choudhary, Matthew L. Bechtold, Mohamed O. Othman,Srinivas R. Puli, Wilson P. Pais, Mainor R. Antillon, Praveen K. RoyBackground: Acute pancreatitis is a common complication of ERCP. Over the years,various methods and drugs have been used in an effort to prevent thiscomplication; however, controversy exists. Several randomized clinical trials (RCTs)have evaluated the use of stents in the prevention of post-ERCP pancreatitis withinconsistent results. We conducted a meta-analysis for the efficacy of prophylacticstents for prevention of post-ERCP pancreatitis. Methods: MEDLINE, CochraneCentral Register of Controlled Trials & Database of Systematic Reviews, PubMed,and recent abstracts from major conference proceedings were searched (through10/07). RCTs comparing prophylactic stents to no stents for post-ERCP pancreatitiswere included. Standard forms were used to extract data by two independentreviewers. The effects of stents were analyzed by calculating pooled estimates ofpost-ERCP pancreatitis, hyperamylasemia, hospital stay, and grade of pancreatitis.Separate analyses were performed for each outcome by using odds ratio (OR) orweighted mean difference (WMD). Random effects model was used. Publicationbias was assessed by funnel plots. The quality of the studies was graded by Jadadscores. Heterogeneity among studies was assessed by calculating I2 measure ofinconsistency. Results: Six RCTs (N Z 423) met the inclusion criteria with nosignificant heterogeneity. All trials used stents of 5–7 Fr size. 4 trials used stents of2–2.5cm in length, whereas the other 2 trials used stents of R 3cm in length.Prophylactic stents decreased the odds of post-ERCP pancreatitis (OR 0.20, 95% CI:0.08–0.51, p Z 0.0001; NNT 7) and the level of hyperamylasemia (WMD -320.71,95% CI: -395.81 – -245.62, p Z 0.00001). Sub-group analysis showed a reduction inthe odds of developing pancreatitis with shorter stents (2–2.5cm) (OR 0.20, 95% CI:0.06–0.67, pZ 0.01; NNT 6). However, longer stents (3–5cm) were not protectiveagainst post-ERCP pancreatitis (OR 0.16, 95 % CI: 0.03–1.02). Stents did notinfluence the severity of post-ERCP pancreatitis (OR 0.46, 95% CI: 0.19 – 1.12, p Z0.09). No significant publication bias was noticed. Conclusions: Prophylactic stentplacement prevents post-ERCP pancreatitis and hyperamylasemia. Shorter length ofthe stents (2–2.5cm) prevented post-ERCP pancreatitis, whereas the longer stents(3–5cm) did not.

S1511

ERCP-Induced Pancreatitis in Primary Sclerosing Cholangitis:

Risk Factors and Proposed Scoring System for Guiding

Prophylactic Pancreatic Stent TherapyFerga C. Gleeson, Todd H. Baron, Felicity Enders, Gregory J. Gores,Andrea a. Gossard, Christopher J. Gostout, Keith D. Lindor,Bret T. Petersen, Mark D. Topazian, Michael J. LevyBackground: In the setting of PSC, ERCP is often performed for diagnosticand/or therapeutic intent. While prior studies have identified risk factors forERCP-induced pancreatitis (EIP), the prognostic value of these risk factors hasnot been adequately studied in patients with PSC. Aims: In patients with PSCundergoing ERCP: 1) to identify patient and procedural factors associated withEIP, and 2) to develop a scoring system to identify patients at increased risk ofEIP who may benefit from pancreatic duct (PD) stenting. Methods: Aprospectively maintained database was reviewed to identify all PSC patients whohad undergone ERCP procedures over 5 ½ years. Patient and procedure relatedpotential risk factors for EIP were analyzed. EIP was defined per the 1991consensus workshop guidelines. Statistical Methods: A logistic regression modelwas performed to estimate the odds ratio associated with each variable.Parameter estimates were calculated in order to design a logistic odds equationfor EIP. ROC analysis was used to evaluate an alternative risk score to aid patientselection most likely to benefit from prophylactic PD stenting. Results: 869 ERCPprocedures were performed on 375 patients with PSC (67% male; mean age 47.9� 14.5). A median of 2 procedures, [range 1-14] was performed. EIP developedin 15 (1.7%) patients. EIP rates were not influenced biliary cytology brushing,dilation, stone extraction, intraductal ultrasonography, intraluminalbrachytherapy, photodynamic therapy, or biliary stent insertion or exchange. Theprevalence of EIP was less in a subgroup with prior performance of anendoscopic sphincterotomy (ES) (p Z 0.002). Multivariate analysis identified 3risk factors associated with EIP, including: native papilla with ES (OR 5, 95% CI1-9), native papilla without ES (OR 6, 95% CI 2-24), and intraductal biopsy (OR10, 95% CI 2-62). A risk score was applied to each procedure, assigning 1 pointfor age !40Y or native papilla ES performance and 2 points for eitherperformance of intraductal biopsy or, if no ES performed on a native papilla.The magnitude of this score could range from 0 to 5. ROC curve analysis [AUC0.85] demonstrated that a risk score R3 had an 80% EIP accuracy. Conclusion:Prognostic variables can be used to determine the risk of EIP in patients withPSC. A predictive risk score of R3 indicates an increased risk of EIP. ProphylacticPD stents may be beneficial in this subgroup. Our data indicate thatperformance of ES provides a protective influence during subsequent exams andshould be considered during an index exam for patients likely to undergo repeatERCP.

lume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB153