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273 Similar Efficacies of Endoscopic Ultrasound-Guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction
Abstracts
271 Endoscopic ultrasound-guided gallbladder drainage versus endoscopic transpapillary gallbladder drainage for acute cholecystitis in high risk surgical patients: which is better? Dongwook Oh*, Sang Soo Lee, Dong Hui Cho, Tae Jun Song, Do Hyun Park, Dong Wan Seo, Sung Koo Lee, Myung-Hwan Kim Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea (the Republic of) Background and Aims: Although endoscopic transpapillary gallbladder drainage (ETGBD) has been reported to be an effective treatment for acute cholecystitis, it may not be technically feasible in difficult cases. As an alternative, endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has been introduced as a safe and effective method for drainage of the gallbladder. The aim of this study was to compare the outcomes of EUS-GBD and ETGBD. Patients and Methods: Retrospective review of a prospectively collected endoscopic gallbladder drainage database at the Asan Medical Center (From January 2010 to December 2014) was performed to identify consecutive patients with acute cholecystitis who underwent attempted endoscopic gallbladder drainage for decompression of the gallbladder. A total of 179 patients (83 in EUS-GBD group and 96 in ETGBD group) who had undergone either EUS-GBD or ETGBD for acute cholecystitis were included. The inclusion criteria were: 1) acute cholecystitis, 2) advanced malignancy and/or poor surgical performance (class III or IV on the American Society of Anesthesiologists Physical Status classification system). Results: Technical success rate (EUS-GBD vs. ETGBD group; 98.8% (82/83) vs. 83% (80/96), P<0.05) and clinical success rate (EUSGBD vs. ETGBD group; 95.2% (79/83) vs. 83% (80/96), P<0.05) were significantly higher in EUS-GBD group than ETGBD group. There was no significant differences in the mean procedure time (EUS-GBD vs. ETGBD group; 21 6.2 minutes vs. 19.5 9.6 minutes, PZ0.22) and procedure-related adverse event rate (EUS-GBD vs. ETGBD group; 8.4% (7/83) vs. 8.3% (8/96), PZ0.74). In the EUS-GBD group, procedural adverse events included self-limitied pneumoperitoneum (3/83, 3.6%), selflimited abdominal pain (3/83, 3.6%), and duodenal perforation (1/83, 1.2%). In the ETGBD group, post-procedural pancreatitis occurred in 8 patients (8.3%). All procedure-related adverse events resolved with conservative treatment. During the follow-up periods, acute cholecystitis recurred more frequently in ETGBD group (EUS-GBD vs. ETGBD group; 7.2% (6/83) vs. 17.7% (17/96), PZ0.02) As a result, reintervention was more frequently needed in ETGBD group (EUS-GBD vs. ETGBD group; 7.2% (6/83) vs. 17.7% (17/96), PZ0.02). Conclusion: In patients with acute cholecystitis and unfit for surgery, EUS-GBD might be more useful treatment method than ETGBD.
272 Fully Covered Self-Expanding Metal Stents Versus Lumen-Apposing Fully Covered Self-Expanding Metal Stent Versus Plastic Stents for Endoscopic Drainage of Pancreatic Walled-off Necrosis: Clinical Outcomes and Success Ali A. Siddiqui*1, Thomas E. Kowalski1, David E. Loren1, Ammara Khalid1, Ayesha Soomro1, Syed M. Mazhar1, Laura Isby2, Michel Kahaleh2, Kunal Karia2, Joseph Yoo1, Andrew Ofosu1, Beverly Ng1, Reem Z. Sharaiha2 1 Gastroenterology, Thomas Jefferson University, Philadelphia, PA; 2Weil Cornell University, New York, NY Purpose: Endoscopic transmural drainage of pancreatic walled-off necrosis (WON) has been conducted using double pigtail plastic (DP) or fully covered self-expanding metal (FCSEMS) stents. While a novel lumen-apposing fully covered self-expanding metal stent (LAMS) has demonstrated to be a promising alternative, there is limited data comparing the 3 types of stents. Aim: To compare the clinical outcomes and adverse events (AE) of EUS-guided drainage of WON with DP stents, FCSEMS & LAMS. Methods: Consecutive patients in 3 centers with WON managed by EUSguided drainage were divided into 3 groups: 1) those that underwent drainage using DP stents, 2) drainage using FCSEMS, 3) drainage using LAMS. Technical success (ability to access and drain a WON by placement of transmural stents), early adverse events (AE), number of procedures performed per patient to achieve WON resolution, and long term success (complete resolution of the WON without need for further re-intervention at 6 months following treatment) were evaluated. Results: From 2010 to 2015, 313 patients (76.6% female; mean age 53 years) underwent WON drainage, including 106 who were drained using DP stents, 121 using FCSEMS, & 86 using LAMS. The 3 groups were matched with age, etiology of the pancreatitis, WON size, and location. The etiology of the patients’ pancreatitis was gallstones (40.6%), alcohol (30.7%), idiopathic (13.1%), and other causes (15.6%). The mean cyst size was 102 mm (20-510 mm). The mean number of endoscopy sessions was 2.5 (range: 1-13). The technical success rate of stent placement was 99%. Early AE were noted in 27/313 (8.6%) patients (6Zperforation, 8Zbleeding, 9Zsuprainfection, 7Zother). Successful endoscopic therapy was noted in 277/313 (89.6%) patients. When comparing the 3 groups, there was no difference in the technical success (pZ0.37). Procedure related complications were significantly lower in the FCSEMS group compared to DP and LAMS group (1.6%, 7.5%, and 9.3%, p<0.01). On 6-month follow-up, complete resolution of WON using DP stents was lower
AB136 GASTROINTESTINAL ENDOSCOPY Volume 83, No. 5S : 2016
compared to those who underwent drainage with FCSEMS and LAMS (81% vs. 95% vs. 90%; pZ0.001). The mean number of procedures required to WON resolution was significantly lower in LAMS compared to FCSEMS and DP stents (2.2 vs. 3 vs. 3.6 respectively, pZ0.04). On multivariable analysis, DP stents remain the sole negative predictor for successful resolution of WON (OR 95% CI 0.18; 0.06-0.53; pZ0.002) after adjusting for age, sex, and WON size. Although there was no significant difference between the FCSEMS and LAMS for WON resolution, LAMS was more likely to have early AE (OR 6.6, pZ0.02). Conclusions: EUS-guided drainage of WON using FCSEMS and LAMS is superior to DP stents in terms of overall treatment efficacy. The number of procedures required to WON resolution was significantly lower in LAMS compared to FCSEMS and DP stents.
Figure 1. Multivariate Analysis of the Predictors for Success for WON Resolution.
273 Similar Efficacies of Endoscopic Ultrasound-Guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction Tae Hoon Lee*1, Jun-Ho Choi2, Do Hyun Park3, Tae Jun Song3, Dong Uk Kim4, Woo Hyun Paik5, Sang Soo Lee3, Dong Wan Seo3, Sung Koo Lee3, Myung-Hwan Kim3 1 Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea (the Republic of); 2Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea (the Republic of); 3Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea (the Republic of); 4 Internal Medicine, Pusan National University School of Medicine, Busan, Korea (the Republic of); 5Internal Medicine, Inje University Ilsan Paik Hospital, Inje University School of Medicine, Ilsan, Korea (the Republic of) Background and Aims: Although percutaneous transhepatic biliary drainage (PTBD) is the standard method for draining malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatographies (ERCPs), use of endoscopic ultrasound-guided transmural biliary drainage (EUS-BD) is increasing. We performed a multicenter, open-label, randomized trial to compare EUS-BD vs PTBD for malignant distal biliary obstruction after failed ERCP. Methods: Patients with unresectable malignant distal biliary obstructions and failed primary ERCP, due to inaccessible papilla, were assigned to groups that underwent EUS-BD with an all in 1 device for direct deployment of a partially covered metal stent (without further fistula tract dilation, nZ34) or PTBD (nZ32). The procedures were performed at 4 tertiary academic referral centers in South Korea from October 2014 through March 2015; patients were followed through June 2015. The primary endpoint was technical success, calculated using a non-inferiority model. Secondary endpoints were functional success, procedure-related adverse events, rate of unscheduled re-intervention, and quality of life (QOL). Results: Rates of primary technical success were 94.1% (32/34) in the EUS-BD group and 96.9% (31/32) in the PTBD group (1-sided 97.5% confidence interval [CI] lower limit, 12.7%; PZ.008 for a non-inferiority margin of 15%). Rate of functional success were 87.5% (28/32) in the EUS-BD and 87.1% (27/31) in the PTBD group (PZ1.00). The proportions of procedure-related adverse events were 8.8% in the EUS-BD group vs 31.2% in the PTBD group (PZ.022); the mean frequency of unscheduled re-intervention was 0.34 in the EUSBD group vs 0.93 in the PTBD (PZ.02) were higher in the PTBD group. The QOL was similar between groups. Conclusions: EUS-BD and PTBD had similar levels of efficacy in patients with unresectable malignant distal biliary obstruction and inaccessible papilla, based on rates of technical and functional success and QOL. However, EUS-BD produced fewer procedure-related adverse events and unscheduled re-interventions.
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271 Endoscopic ultrasound-guided gallbladder drainage versus endoscopic transpapillary gallbladder drainage for acute cholecystitis in high risk surgical patients: which is better? Dongwook Oh*, Sang Soo Lee, Dong Hui Cho, Tae Jun Song, Do Hyun Park, Dong Wan Seo, Sung Koo Lee, Myung-Hwan Kim Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea (the Republic of) Background and Aims: Although endoscopic transpapillary gallbladder drainage (ETGBD) has been reported to be an effective treatment for acute cholecystitis, it may not be technically feasible in difficult cases. As an alternative, endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has been introduced as a safe and effective method for drainage of the gallbladder. The aim of this study was to compare the outcomes of EUS-GBD and ETGBD. Patients and Methods: Retrospective review of a prospectively collected endoscopic gallbladder drainage database at the Asan Medical Center (From January 2010 to December 2014) was performed to identify consecutive patients with acute cholecystitis who underwent attempted endoscopic gallbladder drainage for decompression of the gallbladder. A total of 179 patients (83 in EUS-GBD group and 96 in ETGBD group) who had undergone either EUS-GBD or ETGBD for acute cholecystitis were included. The inclusion criteria were: 1) acute cholecystitis, 2) advanced malignancy and/or poor surgical performance (class III or IV on the American Society of Anesthesiologists Physical Status classification system). Results: Technical success rate (EUS-GBD vs. ETGBD group; 98.8% (82/83) vs. 83% (80/96), P<0.05) and clinical success rate (EUSGBD vs. ETGBD group; 95.2% (79/83) vs. 83% (80/96), P<0.05) were significantly higher in EUS-GBD group than ETGBD group. There was no significant differences in the mean procedure time (EUS-GBD vs. ETGBD group; 21 6.2 minutes vs. 19.5 9.6 minutes, PZ0.22) and procedure-related adverse event rate (EUS-GBD vs. ETGBD group; 8.4% (7/83) vs. 8.3% (8/96), PZ0.74). In the EUS-GBD group, procedural adverse events included self-limitied pneumoperitoneum (3/83, 3.6%), selflimited abdominal pain (3/83, 3.6%), and duodenal perforation (1/83, 1.2%). In the ETGBD group, post-procedural pancreatitis occurred in 8 patients (8.3%). All procedure-related adverse events resolved with conservative treatment. During the follow-up periods, acute cholecystitis recurred more frequently in ETGBD group (EUS-GBD vs. ETGBD group; 7.2% (6/83) vs. 17.7% (17/96), PZ0.02) As a result, reintervention was more frequently needed in ETGBD group (EUS-GBD vs. ETGBD group; 7.2% (6/83) vs. 17.7% (17/96), PZ0.02). Conclusion: In patients with acute cholecystitis and unfit for surgery, EUS-GBD might be more useful treatment method than ETGBD.
272 Fully Covered Self-Expanding Metal Stents Versus Lumen-Apposing Fully Covered Self-Expanding Metal Stent Versus Plastic Stents for Endoscopic Drainage of Pancreatic Walled-off Necrosis: Clinical Outcomes and Success Ali A. Siddiqui*1, Thomas E. Kowalski1, David E. Loren1, Ammara Khalid1, Ayesha Soomro1, Syed M. Mazhar1, Laura Isby2, Michel Kahaleh2, Kunal Karia2, Joseph Yoo1, Andrew Ofosu1, Beverly Ng1, Reem Z. Sharaiha2 1 Gastroenterology, Thomas Jefferson University, Philadelphia, PA; 2Weil Cornell University, New York, NY Purpose: Endoscopic transmural drainage of pancreatic walled-off necrosis (WON) has been conducted using double pigtail plastic (DP) or fully covered self-expanding metal (FCSEMS) stents. While a novel lumen-apposing fully covered self-expanding metal stent (LAMS) has demonstrated to be a promising alternative, there is limited data comparing the 3 types of stents. Aim: To compare the clinical outcomes and adverse events (AE) of EUS-guided drainage of WON with DP stents, FCSEMS & LAMS. Methods: Consecutive patients in 3 centers with WON managed by EUSguided drainage were divided into 3 groups: 1) those that underwent drainage using DP stents, 2) drainage using FCSEMS, 3) drainage using LAMS. Technical success (ability to access and drain a WON by placement of transmural stents), early adverse events (AE), number of procedures performed per patient to achieve WON resolution, and long term success (complete resolution of the WON without need for further re-intervention at 6 months following treatment) were evaluated. Results: From 2010 to 2015, 313 patients (76.6% female; mean age 53 years) underwent WON drainage, including 106 who were drained using DP stents, 121 using FCSEMS, & 86 using LAMS. The 3 groups were matched with age, etiology of the pancreatitis, WON size, and location. The etiology of the patients’ pancreatitis was gallstones (40.6%), alcohol (30.7%), idiopathic (13.1%), and other causes (15.6%). The mean cyst size was 102 mm (20-510 mm). The mean number of endoscopy sessions was 2.5 (range: 1-13). The technical success rate of stent placement was 99%. Early AE were noted in 27/313 (8.6%) patients (6Zperforation, 8Zbleeding, 9Zsuprainfection, 7Zother). Successful endoscopic therapy was noted in 277/313 (89.6%) patients. When comparing the 3 groups, there was no difference in the technical success (pZ0.37). Procedure related complications were significantly lower in the FCSEMS group compared to DP and LAMS group (1.6%, 7.5%, and 9.3%, p<0.01). On 6-month follow-up, complete resolution of WON using DP stents was lower
AB136 GASTROINTESTINAL ENDOSCOPY Volume 83, No. 5S : 2016
compared to those who underwent drainage with FCSEMS and LAMS (81% vs. 95% vs. 90%; pZ0.001). The mean number of procedures required to WON resolution was significantly lower in LAMS compared to FCSEMS and DP stents (2.2 vs. 3 vs. 3.6 respectively, pZ0.04). On multivariable analysis, DP stents remain the sole negative predictor for successful resolution of WON (OR 95% CI 0.18; 0.06-0.53; pZ0.002) after adjusting for age, sex, and WON size. Although there was no significant difference between the FCSEMS and LAMS for WON resolution, LAMS was more likely to have early AE (OR 6.6, pZ0.02). Conclusions: EUS-guided drainage of WON using FCSEMS and LAMS is superior to DP stents in terms of overall treatment efficacy. The number of procedures required to WON resolution was significantly lower in LAMS compared to FCSEMS and DP stents.
Figure 1. Multivariate Analysis of the Predictors for Success for WON Resolution.
273 Similar Efficacies of Endoscopic Ultrasound-Guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction Tae Hoon Lee*1, Jun-Ho Choi2, Do Hyun Park3, Tae Jun Song3, Dong Uk Kim4, Woo Hyun Paik5, Sang Soo Lee3, Dong Wan Seo3, Sung Koo Lee3, Myung-Hwan Kim3 1 Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea (the Republic of); 2Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea (the Republic of); 3Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea (the Republic of); 4 Internal Medicine, Pusan National University School of Medicine, Busan, Korea (the Republic of); 5Internal Medicine, Inje University Ilsan Paik Hospital, Inje University School of Medicine, Ilsan, Korea (the Republic of) Background and Aims: Although percutaneous transhepatic biliary drainage (PTBD) is the standard method for draining malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatographies (ERCPs), use of endoscopic ultrasound-guided transmural biliary drainage (EUS-BD) is increasing. We performed a multicenter, open-label, randomized trial to compare EUS-BD vs PTBD for malignant distal biliary obstruction after failed ERCP. Methods: Patients with unresectable malignant distal biliary obstructions and failed primary ERCP, due to inaccessible papilla, were assigned to groups that underwent EUS-BD with an all in 1 device for direct deployment of a partially covered metal stent (without further fistula tract dilation, nZ34) or PTBD (nZ32). The procedures were performed at 4 tertiary academic referral centers in South Korea from October 2014 through March 2015; patients were followed through June 2015. The primary endpoint was technical success, calculated using a non-inferiority model. Secondary endpoints were functional success, procedure-related adverse events, rate of unscheduled re-intervention, and quality of life (QOL). Results: Rates of primary technical success were 94.1% (32/34) in the EUS-BD group and 96.9% (31/32) in the PTBD group (1-sided 97.5% confidence interval [CI] lower limit, 12.7%; PZ.008 for a non-inferiority margin of 15%). Rate of functional success were 87.5% (28/32) in the EUS-BD and 87.1% (27/31) in the PTBD group (PZ1.00). The proportions of procedure-related adverse events were 8.8% in the EUS-BD group vs 31.2% in the PTBD group (PZ.022); the mean frequency of unscheduled re-intervention was 0.34 in the EUSBD group vs 0.93 in the PTBD (PZ.02) were higher in the PTBD group. The QOL was similar between groups. Conclusions: EUS-BD and PTBD had similar levels of efficacy in patients with unresectable malignant distal biliary obstruction and inaccessible papilla, based on rates of technical and functional success and QOL. However, EUS-BD produced fewer procedure-related adverse events and unscheduled re-interventions.
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