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a frequently encountered clinical problem in patients with inoperable malignant bile duct obstruction. New techniques are needed to assist with stent clearance and maintenance of stent patency. The feasibility and safety of a novel endobiliary radiofrequency ablation (RFA) catheter in the treatment of malignant biliary strictures has been demonstrated in a recent pilot study. A potential role in the treatment of SEMS occlusion has not been developed or studied. The aim of this study was to describe the application of endobiliary RFA for the clearance of biliary SEMS occlusion. Patients and Methods: We describe the evolution and preliminary investigation of the use of endoscopically-applied RFA to restore patency to occluded biliary SEMS in a feasibility and safety study. Ethical and new devices committee approval was obtained for the use of RFA for this purpose. Patients with advanced hepato-pancreato-biliary malignancy were treated in a single tertiary care centre by two experienced operators. Biliary metal stent obstruction secondary to tumour ingrowth was treated with RFA deployed directly within the lumen of the occluded stent at ERCP. Patients were followed up until death or the end of the study period. The success of RFA was determined by the re-establishment of luminal patency in association with relief of jaundice and/or cholangitis. Stent re-occlusion was treated with further RFA as appropriate. Results: 11 patients with inoperable malignancy (6 pancreatic, 3 cholangiocarcinoma, 2 hepatic metastates) underwent a total of 15 RFA procedures (4 repeat) with technically successful RFA catheter deployment in all. 8 patients had evidence of metastatic disease at time of RFA, the remaining 3 had advanced local disease. The procedure was well tolerated with a median inpatient stay of 3d (1-11), and no associated significant adverse events or morbidity. RFA helped re-estalish SEMS patency in all but one procedure (in a patient with disseminated metastatic pancreatic carcinoma). Median SEMS patency post RFA was 146 days. The first six patients treated underwent elective prophylactic insertion of a second SEMS at time of RFA, but subsequent experience in the following five patients showed this was not necessary to maintain patency. Stent re-occlusion occurred in 5 of 11 patients over a median follow-up of 131d (37-602), 4 of whom were treated with repeat RFA. Conclusions: RFA is a viable and safe novel technique to aid biliary stent clearance in patients with advanced hepato-pancreato-biliary malignancy, which may obviate the need for further SEMS placement in selected patients. Further studies will help delineate its precise role.
Mo1292 Risk Factors for Early and Late-Onset Cholecystitis After Y-Stent Placement in Patients With Malignant Hilar Obstruction Dong Uk Kim*, Gwang HA Kim, Geun Am Song, Dae Hwan Kang, Bong Eun Lee Gastroenterology, Pusan National University School of Medicine, Busan, Republic of Korea Background/Aims: Cholecystitis complicated after endoscopic bilateral placement of metal stents has been reported in as many as 1.9% to 12% of cases. Cholecystitis may be increasing, whose occurrence is problematic especially after bilateral metal stent placement in patients with malignant hilar obstruction. The aim of this study is to evaluate the prevalence and risk factors of early (within 30 days) and late (after 30 days) onset cholecystitis after Y-configured metal stent placement. Patients/Methods: From June 2005 to Aug 2009, 84 patients treated with a metal stent for malignant hilar obstruction were enrolled. Previous cholecystectomy was performed on three patients due to gallbladder stones, and two patients who failed to achieve adequate drainage received percutaneous biliary drainage. Therefore, a total of 79 patients were finally accepted in this study. The incidence and characteristics of patients with early or late-onset cholecystitis were evaluated and compared with those of patients without cholecystitis. We retrospectively reviewed gallbladder filling by contrast medium during endoscopic retrograde cholangiopancreatography (ERCP), cystic duct involvement of tumor mass on computed tomography (CT), presence of gallbladder stones, and primary tumor types in endoscopic database and image data of previous ongoing study. Results: There were 7 (8.9%) and 21 (26.6%) patients diagnosed with early and late-onset cholecystitis, respectively. In the case of early-onset cholecystitis, 3.8 days were, on average, taken (ranging from 2 to 5 days) since metal stent placement to the onset of cholecystitis. We identified presence of gallbladder filling by contrast media in patients with cystic duct involvement of tumor mass on CT as a significant risk factor(p⫽0.003). In the case of late-onset cholecystitis, previous early onset cholecystitis was only significant risk factors. There were intervals of 212.5 days on average (ranging from 27 to 525 days) between stent placement and late-onset cholecystitis. Conclusions: This study demonstrated that early-onset cholecystitis may occur in patients with gallbladder filling by contrast midea during metal stent placement in the state of cystic duct invasion by malignant tumors and with diabetes mellitus. However, late-onset cholecystitis is not related to any of those risk factors.
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Mo1293 Safety and Efficacy of Pancreatic Guidewire Placement for Achieving Selective Biliary Cannulation Azumi Suzuki*, Koichiro Mandai, Soichiro Morikawa, Koji Uno, Kenjiro Yasuda Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan Background: Although pancreatic guidewire placement (P-GW) is effective in difficult cases of selective biliary cannulation, it may increase the risk of postendoscopic retrograde cholangiopancreatography pancreatitis (PEP). However, whether P-GW is a risk factor for PEP has not been sufficiently investigated. Aim: We evaluated the efficacy of P-GW and investigated whether it is a risk factor for PEP. Methods: The study included 1292 endoscopic retrograde cholangiopancreatography (ERCP)-related procedures that were performed in 627 patients at Kyoto Second Red Cross Hospital from September 2009 to August 2011. Cases in which procedures were not intended to achieve selective biliary cannulation and cases with a history of sphincterotomy or endoscopic papillary dilatation were excluded from the study. In almost all patients, initial biliary cannulation was attempted using a standard catheter and contrast injection. However, when this failed, wire-guided cannulation (WGC), P-GW, and/or precut were performed. All procedures were performed or supervised by experienced endoscopists. The success rate of selective biliary cannulation with P-GW and the relationship between P-GW and PEP were retrospectively analyzed. To adjust for other risk factors, we used multiple logistic regression analysis to generate odds ratios as an estimate of relative risk. The risk factors investigated included sex, age, contrast medium injection into the pancreatic duct, WGC, endoscopic biliary stenting, endoscopic sphincterotomy, and procedure time. PEP was diagnosed according to Cotton’s criteria. Results: A total of 444 ERCP-related procedures were analyzed in 384 patients after implementing the exclusion criteria. Initial biliary cannulation was successful in 78.8% procedures (350/444). Of the remaining 94 procedures with an unsuccessful initial biliary cannulation, P-GW was performed in 60 procedures. Of these, selective biliary cannulation was successfully achieved in 65.0% (39/ 60). Of the total 444 ERCP-related procedures, 3.4% resulted in PEP (15/444; mild, 10 and moderate, 5), and among P-GW procedures, 11.7% (7/60) resulted in PEP. Multiple logistic regression analysis identified P-GW as an independent and significant risk factor for PEP (odds ratio, 3.563; 95% confidence interval, 1.092-11.628; p ⫽ 0.035). Conclusion: P-GW is a useful technique to achieve selective biliary cannulation in difficult cases. However, P-GW is also a risk factor for PEP and should be performed after careful consideration of indications.
Mo1294 Prospective Evaluation of Fluorescence in Situ Hybridization and Thinprep for Diagnosis of Malignant Bile Duct Strictures Sarah S. Cho*1, Cameron J. Bell1, Ian D. Norton1, Nisha Singh2, Anthony Gill2 1 Department of Gastroenterology, Royal North Shore Hospital, Sydney, NSW, Australia; 2Department of Anatomical Pathology, Royal North Shore Hospital, Sydney, NSW, Australia Background and Aim: Diagnosis of malignant bile duct strictures based on the result of standard cytology of bile duct brushings is often challenging due to its low sensitivity. A small number of studies have shown that advanced cytological techniques such as fluorescence in situ hybridization (FISH) could lead to increased sensitivity of cytology. The limitations of advanced cytological techniques such as FISH are significant cost and limited availability. Fluid based approaches such as ThinPrep are cheap and readily available. The aim of this study was to assess the clinical utility of FISH and ThinPrep for the diagnosis of malignant bile duct strictures. Methods: Brush cytologic specimens from 50 consecutive patients with indeterminate bile duct strictures found during ERCP over a 12-month period between February 2010 and February 2011 were examined by all 3 techniques (cytology, FISH, and ThinPrep). Following preparation of slides for standard cytological analysis, the cytology brush was placed in a vial containing fixative solution instead of being discarded. Two monolayer slides were then prepared using the ThinPrep 2000 processor for morphological examination and FISH. The FISH assay used a mixture of fluorescently-labeled probes to the centromeres of chromosomes 3,7, and 17 and chromosomal band 9p21 to identify cells having chromosomal abnormalities. A patient’s specimen was deemed positive for malignancy if 5 cells showed gains of two or more of the four probes. Results: Fifty patients with indeterminate bile duct strictures (male⫽26) were included in the study. The mean age of patients was 73 years (range 47-85). Thirty-two of the 50 patients (64%) had surgical pathologic and/or clinical evidence of malignancy. The sensitivity of cytology, FISH, and ThinPrep for the detection of malignancy in bile duct brushing specimens in these patients was 73%, 60%, and 70%, respectively. The specificity of cytology, FISH, and ThinPrep was 100%, 88% and 94%, respectively. Nine patients with malignant bile duct strictures had false negative cytology results. Five of these 9 patients (56%) had either or both positive FISH and ThinPrep results (both positive 2; FISH positive 1; ThinPrep positive 2). Conclusion: FISH and ThinPrep on their own were shown to have only limited utility in diagnosis
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of malignant strictures in this study. However they may serve as useful ancillary tests in selected cases. A rational approach would be to perform conventional cytological analysis on all bile duct brushings during which time excess material in the brush could be suspended in fluid rather than discarded. Only cases that were cytologically indeterminate, or clinically suspicious but cytologically benign, would then be processed to produce slides for FISH analysis and ThinPrep to improve diagnostic yield.
Mo1295 ERCP as a Therapeutic Modality in the Management of Bile Leaks After Orthotopic Liver Transplantation or Liver Resection Sumeet K. Tewani*1, Brian G. Turner2, Ram Chuttani1, Douglas K. Pleskow1, Mandeep Sawhney1 1 Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; 2Division of Gastroenterology & Hepatology, Weill Cornell Medical College, New York, NY Background & Aims: A bile leak is an uncommon but major cause of morbidity after hepatobiliary surgery (HBS). ERCP is effective at treating bile leaks following cholecystectomy (CCY), but there is little data on its effectiveness after HBS, including liver resection or transplantation. We aimed to determine the effectiveness of ERCP at treating bile leaks after HBS and to identify factors associated with failure of ERCP therapy. Methods: All patients referred to our center from 2001-2008 for treatment of a bile leak after HBS were reviewed. Patients referred during the same period for treatment of a bile leak following laparoscopic or open CCY served as the control group. Those without clinical follow-up were excluded from the analysis. Patients whose bile leak did not resolve with a single therapeutic ERCP or who required additional radiological or surgical procedures were categorized as ERCP failures. Results: A total of 223 patients were identified, of which 36 were excluded due to lack of follow-up at our institution and 10 were excluded due to bile leak development after trauma or other upper GI surgery. Of the eligible patients, 50 underwent ERCP for treatment of a bile leak after HBS, and 127 underwent ERCP for treatment of a bile leak following CCY. The mean age of the HBS patients was 55.0 years and 70% were male. The most common presentation was increased bilious output from external drains (86%). The most common leaks identified on ERCP were from the intrahepatic ducts (22%) or surgical anastamosis (20%). The mean age of the CCY patients was 55.2 years and 40% were male (p⫽0.93 for age, p ⬍0.001 for sex). The most common presentations were abdominal pain (69%) and leak on imaging (72%). The most common leaks were from the cystic duct or duct of Luschka (78%). ERCP was successful at resolving the leak with a single procedure in 89.3% of patients overall. Failure of ERCP occurred in 7 patients (14%) in the HBS group and 12 patients (9.4%) in the CCY group (p⫽0.38). Adjusting for age and sex, patients with non-cystic non-Luschka leaks were 3.3 times more likely to fail ERCP therapy than those with cystic or Luschka leaks (95% CI [1.1-9.4], p⫽0.028). Patients who had a biliary stent placed at ERCP were significantly more likely to succeed than those who did not (p ⬍0.0001). Neither surgical history nor performance of a biliary sphincterotomy at ERCP affected the success rate. The odds of treatment failure were 3.5 times higher for each additional ERCP required ([1.7-6.9], p⫽0.0004). Conclusions: Most patients with bile leaks were successfully treated with a single therapeutic ERCP, regardless of surgical history. Patients with non-cystic non-Luschka leaks, and those who did not have a biliary stent placed at ERCP, were more likely to fail ERCP therapy. Each additional ERCP required for treatment also decreased the rate of successful therapy.
Mo1296 Stone Visualization During ERCP: Does Contrast Concentration Matter? Ioannis Papadopoulos*, Lance T. Uradomo, Eric M. Goldberg, Peter Darwin University of Maryland, Baltimore, MD Background: Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique used to diagnose and treat disorders of the biliary tree and pancreatic duct. This procedure utilizes fluoroscopy to visualize structures as radio-opaque contrast is injected. Choledocholithiasis is one of the most common indications for ERCP. Some endoscopists advocate using half strength contrast during ERCP to improve visualization of small stones. To date there are no published trials which have evaluated the concentration of contrast needed to optimally visualize stones during ERCP. Objective: Using an ex-vivo model, we attempted to establish whether or not there was a substantial difference in the detection and size assessment of biliary stones when using fluoroscopy with half-strength versus full-strength contrast. Methods: Gall bladder stones of varying sizes (3mm, 5mm, and 7mm) from cholecystectomy specimens were used. A 12cm ⫻ 1.7cm latex balloon served as the model bile duct. Three experienced therapeutic endoscopists were the study subjects. Balloons were filled with various numbers and sizes of stones, and placed on a fluoroscopy
table alongside a therapeutic duodenoscope (for size comparison) underneath a gel chest roll (to simulate body tissue). Five combinations of stones evaluated with both full and half-strength contrast (a total of ten simulated cholangiograms) in a random order were presented to the subjects (no stone, one 3mm stone, three 5mm stones, two 7mm stones, and one 3mm stone with three 5mm stones). Contrast (full or half-strength Conray, iothalamate meglumine injection U.S.P. 60%, Mallinckrodt Inc, St Louis, MO, USA) was injected through an inflated 15mm extraction balloon during fluoroscopic visualization. Study subjects were blinded to both the contrast concentration and size/number of stones. Subjects recorded the number of stones they observed, the perceived stone size, and the quality of the image (good, fair, or poor). A sample image of each simulated cholangiogram was saved. Results: Subjects 1, 2, and 3 identified to correct number of stones in 80%, 80%, and 90% of simulations respectively. Stone size estimates were less accurate at 50%, 40%, and 20%. The majority of the images were felt to be “good” for all subjects and there was no correlation between image quality assessment of “good” or “fair” and stone detection or size estimation. There was also no correlation between “good” or “fair” image quality and the concentration of contrast used. Finally, there was no difference in either stone detection or size estimation with full versus half-strength contrast. Conclusions: The results of this ex-vivo study suggest that there is no significant difference for stone detection, size assessment, and image quality when using half versus full-strength contrast for cholangiograms.
Mo1297 Endoscopic Management of Anastomotic Strictures in Deceased Versus Living Donor Liver Transplantation Calvin Chan*1, Fergal Donnellan1, Alan Coss1, Michael F. Byrne1, Charles H. Scudamore2, Urs P. Steinbrecher1, Alan Weiss1, Eric M. Yoshida1 1 Gastroenterology, University of British Columbia, Vancouver, BC, Canada; 2Surgery, University of British Columbia, Vancouver, BC, Canada Background: Endoscopic therapy has been successful in the management of biliary complications following both deceased donor (DDLT) and living donor liver transplantation (LDLT). LDLT is thought to be associated with higher rates of biliary complications, but there are few data on direct comparisons of the success of endoscopic management of anastomotic strictures (AS) between the two groups. Aim: To compare a single center’s experience of endoscopic management of AS in DDLT compared to LDLT. Methods: A retrospective database review of all liver transplant patients who underwent ERCP from May 2003 to August 2011. Data was expressed as mean ⫹/⫺ standard error. The Student’s t-test and Fisher’s exact test were used to analyse the results. A P value of less than 0.05 was considered statistically significant. Results: 362 patients underwent liver transplantation during the study period, including 29 LDLT. Of these, 111 (33.3%) DDLT and 14 (48.3%) LDLT were referred for ERCP management of biliary complications (p⫽0.11). Biliary cannulation was successful in all patients, with 3 patients in DDLT requiring precut for biliary access. The main diagnoses at ERCP were as follows: AS in 33 (10.0%) DDLT versus 8 (27.6%) LDLT (p⫽0.01); bile leak in 24 (7.2%) DDLT versus 2 (6.9%) LDLT (p⫽1.0); choledocholithiasis in 14 (12.6%) DDLT versus 1 (7.1%) LDLT (p⫽1.0); rising LFTs with normal cholangiogram in 28 (25.2%) DDLT and 4 (28.6%) LDLT (p⫽0.31). 6 (1.8%) DDLT were found to have non anastamotic strictures, compared to 0 LDLT. For AS, no difference was found in the mean time to development of stricture (98⫹/⫺17 days for DDLT versus 172⫹/⫺65 days for LDLT, p⫽0.11), mean time to resolution of stricture (268⫹/⫺77 days for DDLT versus 125⫹/⫺37 days for LDLT, p⫽0.34), likelihood of response to ERCP [21 (63.6%) DDLT versus 6 (75%) LDLT, p⫽0.69], and number of ERCPs required to achieve resolution (3.9 ⫹/⫺0.4 DDLT versus 4.7 ⫹/⫺0.9 LDLT, p⫽0.38). Conclusions: Endoscopic treatment is effective in the majority of biliary complications relating to liver transplantation. Anastomotic strictures occurs more frequently in LDLT compared to DDLT, with equivalent endoscopic treatment response and outcomes for both groups.
AB379 GASTROINTESTINAL ENDOSCOPY Volume 75, No. 4S : 2012
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