Mo1238 Comparison of EUS Guided Biliary Drainage With Percutaneous Biliary Drainage: Updated Meta-Analysis

Mo1238 Comparison of EUS Guided Biliary Drainage With Percutaneous Biliary Drainage: Updated Meta-Analysis

Abstracts Mo1236 EUS-Guided Gallbladder Drainage Reduces Late Adverse Event and Need for Re-Intervention Compared With Percutaneous Cholecystostomy i...

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Abstracts

Mo1236 EUS-Guided Gallbladder Drainage Reduces Late Adverse Event and Need for Re-Intervention Compared With Percutaneous Cholecystostomy in Patents Who Are Not Eligible for Surgery Dong Hui Cho*, Sang Soo Lee, Dongwook Oh, Tae Jun Song, Do Hyun Park, Dong Wan Seo, Sung Koo Lee, Myung-Hwan Kim Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (the Republic of) Background and aims: Endoscopic ultrasound guided transmural gall-bladder drainage (EUS-GBD) with covered metal stent has become increasingly used to treat patients with acute cholecystitis who are not a candidate for surgical treatment. However, there are limited data comparing long-term outcomes of EUS-GBD with covered metal stent and conventional percutaneous cholecystostomy. Method: This is a single center, retrospective study comparing long-term outcomes of EUS-GBD and percutaneous cholecystostomy in patients who are not suitable for cholecystectomy. Data about the patient who underwent EUS-GBD for acute cholecysitis is obtained from prospective collected EUS database of out institute. In percutaneous cholecystostomy group, electrical medical record of patients who underwent percutaneous cholecystostomy was reviewed and analyzed. Demographics and procedure related outcomes including early, late adverse events and need for reintervention in each group was compared. Result: A total of 181 patients (74 in EUSGBD group and 107 in percutaneous cholecystostomy group) were enrolled in this study. The cause of cholecystitis and ASA class were similar in both groups. The technical/clinical success rate was 100%/98.6% in EUS-GBD group and 99.1%/97.2% in percutaneous cholecystostomy group (PZ0.591 and 0.646) respectively. Early adverse event rate was also similar between two groups (6.8% in EUS-GBD group vs. 15.0% in percutaneous cholecystostomy group, P Z 0.103). However, late adverse events including migration of stent or dislodgement of drainage tube, stent or tube occlusion, tract inflammation around percutaneous tube, bile leakage and recurrence of cholecystitis was more frequently observed in percutaneous cholecystostomy group (5/74 in EUS-GBD group and 21/107 in percutaneous cholecyststomy group, PZ 0.017). Percutaneous cholecystostomy tube was indwelled for median 20 days (14.0-45.2) after the procedure. A total of 7 patients in EUS-GBD group received re-intervention for adverse events and all of them were conducted successfully. The patients who underwent percutaneous cholecytostomy more frequently received re-intervention for adverse event or recurrence of cholecystitis after removal of cholecystostomy. (7/74 vs. 23/106, P Z 0.041). Conclusion: EUSGBD and percutaneous cholecystostomy were both effective interventions to urgent drainage for acute cholecystitis. However, EUS-GBD might be beneficial than percutaneous cholecystostomy in long term management for the patients with acute cholecystitis who are not suitable for cholecystectomy.

Mo1237 Percutaneous Biliary Drainage Versus EUS Guided Biliary Drainage: A Multicenter Randomized Phase II Study Erwan Bories*1, Jean-Philippe Ratone1, Fabrice Caillol1, Christian Pesenti1, Christophe Zemmour4, Jean-Marie Boher4, Dominique genre4, Marc Barthet2, Bertrand Napoleon3, Marc Giovannini1 1 Endoscopy, PAOLI CALMETTES INSTITUTE, Marseille, France; 2 Endoscopy, CHU Nord, Marseille, France; 3Endoscopy, hopital Mermoz, Lyon, France; 4Biostatistics, Paoli-Calmettes Institute, Marseille, France Aims & Methods: Inclusion criteria were: Benign or malignant obstructive jaundice with failure of ERCP. Exclusion criteria were: ascites, Blood coagulation disorders, stenosis of the right bile duct. Randomization ratio was 1: 1, with a stratification by indication (benign vs malignant) and by centers (4 centers were included). The route of the biliary drainage was randomized as PTB (arm A) and EGD (arm B). But the choice of the EGD technique was free for the operator as (Anterograde transpapillary stenting, choledoco-duodenostomy, hepatico-gastrostomy). The main goal was to evaluate the specific morbidity and mortality during the 30 days following the biliary drainage in each arm. To prove a decrease of 50% of the morbidity rate in the EGD arm (AZ30%, BZ 15%), 55 patients should be included in the EGD arm (B) as a Simon plan in 2 steps with an intermediate analysis to exclude severe adverse events in the EGD arm. Intermediate analysis was performed after inclusion of 47 patients and showed significantly higher morbidity rate in the PTB arm. Then, PTB arm was stopped and inclusions were made only in the EGD arm. Results: Sixty-five patients from 4 centres were screened between 2011 to 2015. Eight patients were excluded (ascites, ERCP finally feasible). Fifty-six patients were randomized (Arm A Z 21/ Arm B Z 35). The 2 groups were similar except the sex ratio (Female: Arm A, n Z 11 ; Arm B, n Z 7 ; p Z 0.012). The biliary stenosis was malignant in 52 cases (Arm A Z 19 ; Arm B Z 33). Biliary access was successful in 100% in the Arm A and

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in 94% in the Arm B. However, technical success was respectively 17/21 (85%) in the Arm A and 33/56 (94%) in the Arm B. No difference was showed regarding the decrease of the bilirubin level after the drainage in the two arms. Median hospitalization duration was shorter in the Arm B (6 days range 3-30 days) than the Arm A (12 days range 2-32 days). Ten patients died 30 days following the biliary drainage, 7 deaths were reliable to biliary drainage procedure (Arm A Z 3, Arm B Z 4) pZ1. Specific complication occurred in twelve patients (62%) in the Arm A vs 7 (31%) in the Arm B pZ0,0276: Bleeding (A Z 5[24%], B Z 3[9%] ; ns), Cholangitis (A Z 3 [14%], B Z1[3%] ), Sepsis not related to cholangitis (A Z 7 [35%], B Z 5 [25%] ), Peritonitis (A Z1[5%], BZ1[3%], ns ), external biliary fistula (AZ1[5%], BZ0[0%], ns). Conclusion: This randomized prospective study showed similar high technical and clinical success rates in PTB and EUS-guided biliary approach. Specific complication rate was higher in the PTB arm than in the EUS-guided biliary drainage. EUS guided biliary drainage should be the first therapeutic approach after failure of ERCP, in selected patients.

Mo1238 Comparison of EUS Guided Biliary Drainage With Percutaneous Biliary Drainage: Updated Meta-Analysis Muhammad Waqas Khan*1, Khwaja F. Haq3, Omair Atiq5, Zubair Khan2, Chiranjeevi Gadiparthi4, Wade M. Lee2 1 Medicine, Jinnah Medical and Dental College, Karachi, Sindh, Pakistan; 2University of Toledo, Toledo, OH; 3Gastroenterology & Hepatology, New York Medical College at Westchester Medical Center, Valhalla, NY; 4Gastroenterology & Hepatology, University of Tennessee Health Science Center, Memphis, TN; 5Gastroenterology & Hepatology, University of Alabama, Montgomery, AL Background: Although endoscopic retrograde cholangiography (ERC) is the first line treatment modality for biliary obstructions it can fail in about 5% cases and such patients have been conventionally managed with percutaneous biliary drainage (PTBD). Recently, EUS guided biliary drainage (EUS-BD) is being increasingly performed for such patients throughout the world. Studies have compared these two approaches and have reached variable conclusions. Aims: We conducted a systematic review and meta-analysis to compare the technical success, clinical success, postprocedure adverse events (AE) and rate of unscheduled re-interventions of these two approaches. Methods: We searched Medline, Embase and Scopus from inception to November 12, 2016 to identify studies comparing EUS-BD with PTBD. Pooled odds ratios (OR) were calculated for technical success, clinical success, AE & unscheduled re-interventions while comparing these two modalities. These were analyzed using random effects model. Quality assessment was done using Newcastle Ottawa Scale (NOS) and Cochrane tool for observational studies and randomized controlled trials (RCTs) respectively. Results: A total of 9 studies (3 RCTs & 6 observational studies) with 483 patients were included in the final analysis. 252 patients underwent EUS-BD and 231 underwent PTBD. All RCTs had high risk of performance bias, while low risk of detection, attrition and selection biases. Two observational studies were of high quality while 3 were of moderate quality and 1 of low quality per NOS. Pooled OR with 95% confidence interval (CI) for technical success was 2.03 (0.65, 2.37), with moderate heterogeneity (I2Z42%). Pooled OR for clinical success was 0.44 (0.22, 0.88), with no heterogeneity (I2Z0%) in favor of EUS-BD. Pooled OR for AE was 0.24 (0.12, 0.48), with moderate heterogeneity (I2Z56%) in favor of EUS-BD. Pooled OR for unscheduled re-intervention was 0.12 (0.07, 0.22), (I2Z0%) in favor of EUS-BD. Conclusions: In comparison to PTBD, EUS-BD is associated with significantly better clinical success, decreased adverse events and reduced re-intervention rates when performed by highly experienced advanced endoscopists.

Clinical success EUS-BD versus PTBD

Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB469

Abstracts

Adverse events EUS-BD versus PTBD

Mo1239 Incidental Thyroid Nodules During Systematic Endoscopic Ultrasound in Digestive Cancer Patients: Frequency and Potential Clinical Impact Cesar R. Ortega Espinosa*, Jose-Guillermo De La Mora-Levy, Juan O. Alonso-Larraga, Julio Sanchez Del Monte, Mauro E. Ramírez-Solís, Angelica Hernandez-Guerrero Gastrointestinal Endoscopy, National Cancer Institute of Mexico, Mexico City, Mexico Background: EUS has a high sensitivity for detection of small lesions adjacent to the GI tract. Systematic EUS aims to provide a complete and detailed examination of all structures within the reach of the instrument. The thyroid gland can be easily explored in all patients while withdrawing the echoendoscope. Incidental thyroid nodules are seen in 3-5% of the general population and 12-19% of patients undergoing neck imaging. Few have any clinical relevance or require further studies. AIMS: to explore the frequency and features of incidental thyroid lesions during EUS in patients with digestive cancer. Material & Methods: All patients sent for staging/ FNA EUS during an 8-month period by one experienced endosonographer using a linear instrument, were included. Patients with previously known thyroid disease/ lesions or head & neck cancer and/or no other imaging study at our institution, were excluded. Demographic variables included: gender, age and presumed oncologic diagnosis. Thyroid lesions were measured in mm and classified according to the American Thyroid Association (ATA) & American College of Radiology (ACR) TIRADS grading. Highly suspicious lesions were considered clinically relevant. Results: A total of 166 patients were included: 94 female & 72 male, with a median age of 53 years (25-81), 61 (25-81) and 53 (37-72) respectively. Of these, 123 were for pancreato-biliary indications, 30 GI-tract and 13 other. 21 patients had at least one thyroid nodule identified by EUS for a prevalence of 13%; 16% in females & 8.3% in males, of which 46 & 67% respectively, were at least highly-suspicious (pZNS). Size varied from 5.2 to 23 mm (median 7mm), only four nodules were larger than 1cm. According to the ATA, 4 were benign, 6 were very-low intermediate suspicion and 11 were highly-suspicious for malignancy for a frequency of 7%. According to TIRADS, 145 were classified as TIRADS 1, 4 as TIRADS 2, 1-TIRADS 3, 13-TIRADS 4b & 4c and 1-TIRADS 5. All four nodules > 1cm fell into the higher grades; however 7 (using ATA) & 9 (TIRADS) were smaller than 1cm. Most clinically relevant lesions presented in males <35 years old and female patients >50. Conclusions: In this selected group of patients with digestive cancer, the frequency of clinically significant, previously undetected thyroid lesions that could have a potential impact on their management was higher than in the general population as well as in those undergoing neck imaging; a systematic and complete EUS examination is suggested in these patients.

1 Divison of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD; 2Division of Digestive and Liver Disease, The University of Texas Southwestern Medical Center, Dallas, TX; 3DIvision of Gastroenterology, Stanford University School of Medicine, Stanford, CA; 4DIvision of Gastroenterology, University of Michigan, Ann Arbor, MI; 5Division of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH; 6Division of Gastroenterology and Hepatology, Wake Forest School of Medicine, Winston Salem, NC; 7Division of Gastroenterology and Hepatology, North Shore-Long Island Jewish, New York, NY; 8Division of Gastroenterology and Hepatology, Borland Groover Clinic, Jacksonville, FL; 9Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; 10Division of Gastroenterology and Hepatology, Mount Sinai, New York, NY; 11Dvision of Gastroenterology, Hepatology and Nutrition, Vanderbilt University, Nashville, TN; 12Digestive Endoscopy Unit, Humanitas Research Hospital, Rozzano, Milan, Italy; 13Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC; 14Division of Gastroenterology, Cedars Sinai Medical Center, Los Angeles, CA

Background: EUS-guided transmural drainage (EUS-TD) of pancreatic walled-off necrosis (WON) with plastic stents (PS) has been associated with variable success given the risk for stent occlusion. Lumen apposing metallic stents (LAMS) offer a larger caliber stent with anti-migration properties and single step deployment. Data comparing LAMS and PS, however, remain scarce in WON. Aims: To compare LAMS with PS in terms of technical success, clinical success (defined as WON < 2 cm within 6 months post-drainage without need for percutaneous drainage (PD) or surgery), and procedure related adverse events (AEs, severity per ASGE lexicon). Methods: This is a multicenter, international, retrospective study involving 14 centers. Consecutive patients who underwent EUS-TD for WON between 1/2012 and 8/2016 were included. Pancreatic pseudocysts were excluded. Results: A total of 187 patients (mean age 55yr, 35% F) were identified with 102 cases of LAMS and 85 cases of PS. WON were most commonly located in pancreatic head (16.8%) or body/tail (78.8%). The mean WON diameter was 10.66.2cm. Most common etiologies of acute pancreatitis were gallstone (41%), alcohol (23%), and idiopathic (18%). Major indications for drainage were abdominal pain (52%), infection (22%), and gastric outlet obstruction (13%). Extent necrosis, paracolic gutter extension, and rate of disconnected pancreatic duct were similar between the two cohorts. Drainage approach was most commonly transgastric (94%) and was not different between both groups. Technical success was achieved in 100% of LAMS and 98.8% of PS patients (pZ0.27). Use of hydrogen peroxide irrigation was greater in LAMS (52% vs. 10% p<0.001), while rate of nasocystic drain insertion was comparable (4% LAMS vs. 7% PS, pZ0.34). Direct endoscopic necrosectomy (DEN) was performed in 75.5% of LAMS and 44.7% of PS, (p<0.001). Need for PD (5.9% WON vs. 11.9% PS, pZ0.14) and surgery (11.8% vs. 16.5% pZ0.35) were comparable between the two groups. Clinical success was significantly greater in LAMS (82% vs 58.3%, p<0.001). There were a total of 45 AEs (22.5%) in 42 patients (mild/moderate 32, severe 13). There was no difference in rate/severity of AEs between the two cohorts. Procedure time was shorter with LAMS (52min vs. 66min, pZ0.004), while post-procedure length of stay was similar (12.5d vs.8.3d, PZ0.24). Recurrence of WON was significantly higher in the PS group (24.5% vs 2.4%, P<0.001). On multivariable analysis, WON extension into the paracolic gutter (OR 13.3, pZ0.03) and disconnected pancreatic duct (OR 20.7, pZ0.04) were identified as independent clinical predictors of WON recurrence following clinical success. Conclusion: LAMS is superior to PS in attaining successful drainage of WON. Other advantages of LAMS include shorter procedure time and fewer WON recurrences. Randomized trials are needed to confirm these findings

Mo1240 Lumen Apposing Stents Are Superior to Plastic Stents in the Management of Pancreatic Walled-Off Necrosis: A Large International Multicenter Study Yen-I. Chen*1, Juliana F. Yang2, Shai Friedland3, Ian Holmes3, Ryan Law4, Amy Hosmer4, Tyler Stevens5, Matheus C. Franco5, Sunguk Jang5, Rishi Pawa6, Nihar Mathur6, Divyesh V. Sejpal7, Sumant Inamdar7, Arvind Trindade7, Jose Nieto8, Tyler M. Berzin9, Michael L. DeSimone9, Christopher J. DiMaio10, Sanchit Gupta10, Patrick Yachimski11, Andrea A. Anderloni12, Todd H. Baron13, Theodore James13, Laith H. Jamil14, Mel A. Ona14, Nuha Alammar1, Eugenie Shieh1, Majidah A. Bukhari1, Olaya Isabella Brewer Gutierrez1, Omid Sanaei1, Lea Fayad1, Dongxun Zhou1, Saowonee Ngamruengphong1, Vivek Kumbhari1, Vikesh Singh1, Alessandro Repici12, Mouen A. Khashab1

AB470 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S : 2017

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