Abstracts
biliary obstruction, UC stents seem to be preferred twice as commonly as FC stents. For benign biliary strictures, FC stents are the predominant choice. PC stents are used uncommonly. FC stents seem to be a more versatile choice being used across a wider range of clinical indications.
Group A Group B Group C Group D Total Patients
UC Stent
PC Stent
FC Stent
Total Patients
69 6 1 1 77
19 1 0 0 20
34 17 24 17 92
122 24 25 18 189
Empiric biliary sphincterotomy was the dominant approach in patients with SOD type I but only a third in SOD type II, less in IRAP and rarely in SOD type III. Empiric pancreatic or dual sphincterotomy was used rarely in all groups. Manometry directed biliary sphincterotomy was performed by a majority respondents in SOD types II and III, less in IRAP and type I. Manometry directed pancreatic sphincterotomy was used by about half respondents in SOD types I, III and IRAP, and less in type II. Dual sphincterotomy was performed in almost one fifth of respondents in all groups with a positive pancreatic SOM. Conclusion: This survey of ASGE members shows considerable variations in methods for managing patients with SOD and IRAP. More stringent studies are needed to provide evidence-based guidance. Table 1. Respondents (N,%) utilization of advanced imaging modalities among patients with suspected SOD and IRAP Intervention MRCP EUS HIDA
Sa1196 Self-Expandable Metal Stents Versus Plastic Stents for Preoperative Biliary Drainage: A Multicenter Prospective Randomized Study Tae Jun Song*1, Sang Soo Lee1, Ji Woong Jang2, Jong Wook Kim3, Do Hyun Park1, Dong Wan Seo1, Sung Koo Lee1, Myung-Hwan Kim1 1 Asan medical center, Seoul, Korea (the Republic of); 2Internal Medicine, Eulgi University, DaeJeon, Korea (the Republic of); 3Inje University Ilsan Paik Hospital, Ilsan, Korea (the Republic of) Background and Aims: Preoperative biliary drainage (PBD) with stent placement has been well accepted as the treatment of choice for patients with malignant biliary obstruction. In PBD, the placement of fully covered self-expandable metal stents (FCSEMS) may provide better patency duration and a lower incidence of cholangitis compared with plastic stents. We aimed to evaluate which type of stent showed better outcomes in PBD. Methods: In this multicenter, prospective randomized trial, we compared PBD with FCSEMS versus plastic stents in 86 patients with malignant biliary obstruction between January 2012 and December 2014. Patients with obstructive jaundice were randomly assigned to undergo PBD either with plastic stents or FCSEMS placement. The primary outcome measured was PBD procedurerelated adverse events (AE). Results: Baseline characteristics were not significantly different between the two groups. Endoscopic stent placement was technically successful in all patients. Procedure-related AE were not significantly different between two groups (plastic vs. FCSEMS group; 16.3% vs. 16.3%, pZ1.0). Reintervention was required in 16.3% of the plastic stent group and 14.0% of the FCSEMS group (pZ1.0). The interval to surgery after PBD (plastic vs. FCSEMS group; 14.2 8.3 vs. 12.3 6.9 days, pZ0.426) was not significantly different between groups. Surgery-related AE occurred in 43.6% of the plastic stent group and 40.0% of the FCSEMS group (pZ0.755). Conclusions: In patients with resectable malignant biliary obstruction, the outcomes of PBD with plastic stents and FCSEMS were similar. Considering the cost-effectiveness, PBD with plastic stents may be preferable to FCSEMS placement.
Sa1197 Sphincter of Oddi Dysfunction: A Survey of Current Practice in USA Peter B. Cotton1, Alejandro L. Suarez*1, Qi Pauls2, Valorie Durkalski-Mauldin2, Gregory A. Cote1 1 Digestive Disease Center, Medical University of South Carolina, Charleston, SC; 2Public Health Sciences, Medical University of South Carolina, Charleston, SC Background: The significance of sphincter of Oddi dysfunction (SOD), and sphincter manometry (SOM) in patients with post-cholecystectomy (post-CCY) pain and idiopathic recurrent acute pancreatitis (IRAP) is unproven. Aim: We sought to define current ERCP practice patterns for patients with post-CCY pain and IRAP. Patients and Methods: We sent an electronic survey to U.S. members of the American Society of Gastrointestinal Endoscopy (ASGE) on May 1st, 2014. Results: There were 170 respondents from 39 states, 54 (32%) of who derived from university hospitals. The majority (135, 79%) performs endoscopic retrograde cholangiopancreatography (ERCP). For SOD in general, MRCP are used by half respondents, EUS less and HIDA scan rarely. Utilization of MRCP and EUS are significantly higher for IRAP (p-value < 0.001) (Table 1). Most respondents believed that a markedly dilated bile duct (>12mm) and elevated transaminases during attacks predicted a good outcome when utilizing ERCP for SOD. There was no consensus on other possible predictors. Data on the use of sphincter manometry (SOM) and sphincterotomy derive from the 135 respondents who perform ERCP (Table 2). SOM was utilized by 40% of respondents for SOD type II, less with SOD type III and IRAP, and rarely in SOD type I.
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SOD in General
IRAP
p-value
81/170 (48) 44/170 (26) 18/170 (11)
117/170 (71) 121/170 (73)
< 0.001 < 0.001
Table 2. Respondents (N,%) utilization of manometry and
sphincterotomy in SOD and IRAP Any SOM Empiric sphincterotomy Biliary (BS) Pancreatic (PS) Dual, pancreatic and biliary (DS) SOM directed sphincterotomy BS only if biliary SOM (+) PS only if pancreatic SOM (+) DS if either SOM (+) DS if pancreatic SOM (+)
SOD I
SOD II
SOD III
IRAP
10/135 (7)
53/135 (40)
39/135 (29)
40/135 (30)
123/135 (91) 3/135 (2) 3/135 (2)
49/135 (36) 0/135 (0) 2/135 (1)
9/135 (7) 1/135 (1) 2/135 (1)
23/135 (17) 7/135 (5) 6/135 (4)
4/10 (40) 5/10 (50) 0/10 (0) 2/10 (20)
32/53 (60) 21/53 (40) 4/53 (8) 9/53 (17)
29/39 (74) 22/39 (56) 4/39 (10) 8/39 (21)
18/40 (45) 18/40 (45) 1/40 (3) 7/40 (18)
Sa1198 Fully Covered Self-Expandable Metal Stents to Dilate Pancreatic Duct Strictures Due to Chronic Pancreatitis: A Pilot Study Rosario Landi, Andrea Tringali*, Vincenzo Bove, Ivo Boskoski, Pietro Familiari, Federico Barbaro, Vincenzo Perri, Guido Costamagna Digestive Endoscopy Unit, Catholic University, Rome, Italy Background and Aim: Symptomatic main pancreatic duct (MPD) strictures secondary to chronic pancreatitis (CP) may be treated endoscopically by insertion of single or multiple plastic stents. MPD stricture resolution after plastic stents removal occurs in near 60% of the cases. We evaluate the use of removable fully covered, self expandable metal stents (FC-SEMS) to dilate MPD strictures secondary to CP. Materials and Methods: Patients (pts with CP and symptomatic MPD stricture located in the head of the pancreas that persisted 3 months or more after placement of a single plastic stent, were enrolled into a prospective single arm trial. A Nitinol FC-SEMS (Bumpy stent, Taewoong, Korea) was inserted and removed after 6 months. FC-SEMS diameter and length were chosen according to stricture anatomy and MPD diameter above the stricture. Stricture resolution was defined as a satisfactory pancreatico-duodenal contrast outflow and absence of pain during continuous flushing with saline (1000 ml/day) for 24 hrs through a 6 fr naso-pancreatic drain positioned after stent removal. Primary objective was FCSEMS removability. Secondary objectives were MPD stricture resolution rate and complications. Follow-up was planned every 6 months during a 2 year. Results: Between December 2012 and October 2014, 15 pts (10 M, mean age 60 years) were enrolled. Pancreatic calcifications were present in 6 (40%) and ESWL was performed in 4. Four pts (27%) had a history of alcohol abuse. In 10 cases the FC-SEMS was inserted through the major papilla, while 5 pts (3 pancreas divisum, 2 dominant dorsal duct) received the FC-SEMS through the minor papilla. All these patients had a prior minor papilla sphincterotomy. One pt developed cholangitis after 24 hours due to occlusion of the biliary sphincterotomy from the FC-SEMS; cholangitis resolved after insertion of a plastic biliary stent. During stenting period 13 pts (87%) were asymptomatic while 2 had recurrent pancreatitis after 4 and 5 months; the FC-SEMS had migrated and the persistent MPD stricture was treated with a plastic stent in both of them. FC-SEMS completely migrated in 7 (47%) pts and could be removed endoscopically in the remaining 8 (53%) cases. Four pts developed a tight stricture induced by FC-SEMS at the level of its proximal end; in one case the stricture was overcome only after EUS-guided pancreatic rendez-vous. Follow-up is ongoing. Results are summarized in the table. Conclusions: FC-SEMS removability from the MPD in CP was feasible in all cases. After a mean follow-up of 15.9 months, 54% of the pts were asymptomatic; this figure is similar to those obtained
Volume 83, No. 5S : 2016 GASTROINTESTINAL ENDOSCOPY AB251
Abstracts
with a single plastic stent. Occurrence of FC-SEMS induced pancreatic strictures is a major issue and deserves further assessment. According to our experience the use of FC-SEMS in the MPD needs careful evaluation in the setting of clinical trials. Table
Patients FC-SEMS removability Complete FC-SEMS distal migration FC-SEMS proximal migration MPD stricture resolution SEMS “induced” MPD stricture Asymptomatic
N
%
Follow-up, mean months (range)
15 8/8 7/15
100 47
-
1/8 10/15 4/15
12 67 27
-
7/13*
54
15.9 (12-24)
*Two patients discontinued the follow-up (pancreatic cancer diagnosed 6 months after stent removal, lost to follow-up).
Sa1199 Protease Inhibitors for the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis (PEP): Cochrane Collaboration Meta-Analysis of Randomized Controlled Trials Anne Hu1, Yuhong Yuan1, Grigorios Leontiadis1, Paul Moayyedi1, Alan N. Barkun2, Frances Tse*1 1 Medicine, McMaster University Medical Centre, Hamilton, ON, Canada; 2 GI Division, McGill University, The Montreal General Hospital, Montreal, QC, Canada Background and Aim: Activation of proteases has been recognized to play a key role in the pathogenesis of acute pancreatitis. Yet, the prophylactic use of protease inhibitors (PI) for the prevention of post endoscopic retrograde cholangiopancreatography pancreatitis (PEP) remains controversial. Current guidelines do not recommend PI for prophylaxis of PEP. We conducted a meta-analysis of randomized placebo controlled trials (RCTs) of protease inhibitors for the prevention of PEP. Methods: We searched MEDLINE, EMBASE, CENTRAL, CINAHL up to October 2015. Conference proceedings from DDW, UEGW and ACG were searched. RCTs that compared the prophylactic use of protease inhibitors vs. placebo in patients undergoing ERCP were included. Study selection, data extraction and quality assessment were conducted independently by two authors. Primary outcome was incidence of PEP. Secondary outcomes included severity of PEP, bleeding, cholangitis, perforation, mortality, and adverse events attributable to the use of PI. Revman 5.3 was used to calculate pooled risk ratios (RR) with 95% confidence intervals (CI, Mandel-Haenszel method; random effects model). Heterogeneity was assessed by Chi2 test (P<0.15) and I2 test (>25%). To explore sources of heterogeneity, we conducted a priorisubgroup analyses according to inclusion of high-risk vs. low-risk patients, dose and duration of drug use, publication type and risk of bias. Sensitivity analyses were carried out using different meta-analytic models (fixed vs. random effects). Results: Twenty RCTs (6897 participants) met the inclusion criteria. Among the nine studies that compared gabexate vs. placebo, the incidence of PEP was 4.7% in the gabexate group vs. 6.7% in the placebo group (RR 0.68; 95% CI 0.42-1.11; I2Z 47%) (Figure 1). Among the six studies that compared ulinastatin vs. placebo, the incidence of PEP was 3.9% in the ulinastatin group vs. 8.2% in the placebo group (RR 0.49; 95% CI 0.30-0.79; I2Z 2%; NNT Z 24) (Figure 1). Among the seven studies that compared nafamostat vs. placebo, the incidence of PEP was 3.8% in the nafamostat group vs. 8.2% in the placebo group (RR 0.44; 95% CI 0.32-0.60; I2Z 0%; NNT Z 22) (Figure 1). There were no significant differences between PI and placebo with respect to bleeding, cholangitis, perforation, mortality, and adverse events. Also, no significant subgroup differences were found according to the severity of PEP. The results were robust to the pre-defined sensitivity analyses. Conclusion: Compared to placebo, the prophylactic use of ulinastatin and nafamostat are more effective in reducing the risk of PEP. Further studies are needed to assess the optimal dose, timing and duration of PI, as well as the cost-effectiveness in different subgroups of patients.
AB252 GASTROINTESTINAL ENDOSCOPY Volume 83, No. 5S : 2016
Figure 1. Meta-analysis comparing protease inhibitors with placebo for the prevention of PEP. PI - Protease Inhibitors, PBO - Placebo
Sa1200 Outcomes Associated With Timing of ERCP Among Inpatients With Cholangitis Vaibhav Wadhwa*1, Sushil Kumar Garg2, Yash Jobanputra3, Rocio Lopez3, Madhusudhan R. Sanaka3 1 Internal Medicine, Cleveland Clinic, Cleveland, OH; 2Internal Medicine, University of Minnesota, Minneapolis, MN; 3Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH Background/Aim: Cholangitis is associated with significant morbidity and mortality in the United States. Endoscopic retrograde cholangiopancreatography (ERCP) with drainage of biliary tree in a timely fashion is an effective treatment for acute cholangitis. There is limited population based data on outcomes associated with timing of ERCP in cholangitis. Our aim was to evaluate outcomes associated with timing of ERCP among hospitalized patients with primary diagnosis of cholangitis. Methods: Data on hospital admissions of all patients was extracted from the National Inpatient Sample (NIS) from 1998 to 2012. Patients were classified as having cholangitis by querying the ICD-9-CM code for the primary diagnosis (576.1). In addition, all procedural codes were queried to identify if ERCP was performed or not (51.10, 51.11, 52.13, 52.92, 51.86, 52.97, 51.88, 52.94, 51.84, 52.98, 51.87, 52.93, 51.85, 51.14, 52.14, 51.64, 52.21, 51.69 or 51.15). “Early ERCP” was defined as having ERCP performed within 2 days of admission and “Late ERCP” was defined as having ERCP performed later than 2 days after admission. Patients with multiple ERCPs during the same admission were classified based on when the 1st procedure was done. Patients not undergoing ERCP were classified as “Without ERCP”. Data are presented as mean standard deviation, median (25%, 75%) or frequency (%). A univariable analysis was performed to assess differences between the 3 groups; continuous variables were compared using t-tests and categorical variables were compared using Rao-Scott chi-square tests. All analyses were performed using SAS (version 9.4, The SAS Institute, Cary, NC). Results: Patients with late ERCP had significantly longer LOS than both those with early ERCP (p<0.001) without ERCP (p<0.001). There was no evidence of a significant difference between those without ERCP and those with early ERCP (pZ0.013). Patients with early ERCP had significantly lower in-hospital mortality than those without ERCP (p<0.001). There was no evidence of a significant difference between those with early ERCP and those with late ERCP (pZ0.076) or those with late ERCP and those without ERCP (pZ0.56). Patients with late ERCP had significantly higher hospital costs than both those with early ERCP (p<0.001). Conclusion: In this large national database study, Early ERCP in patients with cholangitis is associated with better outcomes than patients undergoing late ERCP. Late ERCP is associated with increased length of stay and significantly higher hospital costs. In-patient mortality, however, is not significantly different between cholangitis patients with either early or late ERCP. However, early ERCP group had significantly lower inpatient mortality compared to no ERCP group.
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