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Tu1460 Revision of Bilateral Self-Expandable Metallic Stents for Malignant Hilar Biliary Obstruction
Abstracts
criteria in high risk for choledocholithiasis or intermediate risk with demonstrated CBDS by any diagnostic image as transabdominal ultrasound, biliary magnetic resonance (MRI) and biliopancreatic endoscopic ultrasonography (EUS). Results: We identified CBDS in 571 patients post ERCP (74,05%). We performed a bivariate analysis by age, classifying patients in 2 groups: those over 50 years (nZ499) and those under 50 years (nZ272). Also, we identified CBDS in 69% of patients under 50 years old and 77% in those over 50 years old. Other variables evaluated were: time of performing ERCP since emergency admission, jaundice, pancreatitis, cholangitis, prior cholecystectomy. Patients with positive ERCP findings have twice jaundice and more rates of acute cholangitis. Patients with acute pancreatitis, low alkaline phosphatase levels had more rates of ERCP negative findings. Patients with previous cholecystectomy had more rates of ERCP negative findings. (25% positive CBDS). 126 patients (63%) with ERCP negative findings were previously classified as high risk for choledocholithiasis based on liver enzymes and CBD diameter (non- MRI, non-EUS). Conclusion: Time between admission and ERCP findings could influence in CBDS probability. Acute pancreatitis and total bilirubin were not a strong predictor for CBSD. Some patients with ERCP negative findings were classified in high risk CBSD without confirmatory images. Maybe in these cases, the most significant criteria used to perform ERCP were bilirubin levels. Current criteria to predict CBDS using only laboratory tests and CBD diameter, overestimates risk, especially patients with previous cholecystectomy. So we propose in this scenario perform confirmatory image tests.
Tu1460 Revision of Bilateral Self-Expandable Metallic Stents for Malignant Hilar Biliary Obstruction Jun Hyuk Son*1, Sang Hyub Lee1, Hee Seung Lee2, Seungmin Bang2, Jinwoo Kang1, Jae Woo Lee1, Ji Kon Ryu1, Yong-Tae Kim1 1 Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea (the Republic of); 2 Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea (the Republic of)
trials and in clinical practice. Free DNA may be found in the cellular environment of neoplastic tissues due to rapid cell turn over and as a consequence of progressive mutational acquisition. However, the ability to obtain DNA from the supernatant of extracted stents and the performance of mutational analysis in distinguishing benign from malignant strictures has not been described. Methods: This study is an ongoing, prospective, controlled, single-blinded trial. An interim analysis was prespecified at accrual of 4 patients in each arm. Patients with known benign (post liver transplant anastomotic strictures) and known malignant strictures were enrolled. Plastic biliary stents extracted from patients during ERCP were sent for evaluation (Interpace Diagnostic, Pittsburgh, PA). The reference laboratory was blinded to the clinical history of the patient and the characterization of the stricture as benign or malignant. DNA was extracted from aliquots (supernatant, supernatant plus cells, cells, supernatant from stent) (Qiagen, Valencia, CA) and was quantified by optical density (NanoDrop, Thermo Scientific, Wilmington, DE). Quantitative PCR was used to establish the diagnostic yield. A validated panel included DNA markers for KRAS oncogene mutations and tumor suppressor gene loss-of-heterozygosity (LOH) mutations at 10 genomic loci. The presence or absence of KRAS mutations was examined in codons 12 and 13. Tumor suppressor gene LOH mutations were assessed at 10 loci via capillary gel electrophoresis: 1p (CMM1, Lmyc), 3p (VHL, OGG1), 5q (MCC, APC), 9p (CDKN2A, CDKN2B), 10q (PTEN, MXI1), 17p (TP53), 17q (NME1, RNF34), 18q (SMAD4, DCC), 21q (TFF1, PSEN2), and 22q (NF2). Results: Eight patients were included in the pre-specified interim analysis. Four patients with orthotropic liver transplantation had a known benign biliary anastomotic stricture and four patients had malignant biliary stricture. Mean age was 70.8+/-5.3 yrs. There were two male and six female patients. Mean AST was 112.2+/- 82.1U/L, mean ALT was 146.4+/-178.8 U/L, mean ALP was 452.7+/-334.7 U/L and total bilirubin was 8+/7.9 mg/dl. The supernatant and the KRAS performed with a very high specificity (100%) and a moderate sensitivity (50%); complete mutational analysis (Table 1). Conclusion: Stent supernatant fluid contains analyzable material, which is suitable for molecular characterization. The supernatant and the KRAS mutation analyses performed with very high specificity (100%) and moderate sensitivity (50%) in a small cohort. This interim analysis suggests that the stent supernatant analysis may be a promising adjunct to the low discriminatory capability of brush cytology for biliary strictures.
Background/Aims: Endoscopic biliary decompression using bilateral self-expandable metallic stents (SEMS) is considered as a favorable procedure for unresectable malignant hilar biliary obstruction. However occlusion of the bilateral SEMS is frequently occurred and revision can be challenging. This study was performed to evaluate the efficacy and the long-term patency of revision of bilateral SEMS and to investigate which revision method had better patency, endoscopic or percutaneous in patients with malignant hilar biliary obstruction. Methods: From January 2011 to July 2016, ninety-one patients with hilar biliary obstruction underwent endoscopic bilateral SEMS insertion in two tertiary hospitals located in South Korea. Among 91 patents, 74 patients were followed-up more than 30 days. We retrospectively reviewed the medical records. Results: Of the seventy-four patients, 38 experienced occlusion of previously inserted SEMS and underwent revision. Mean age of the patients was 69.2 years. The most common etiology of hilar biliary obstruction was cholangiocarcinoma (52.6%), followed by gallbladder cancer (34.2%) and the other metastatic cancer (13.2%). The mean patent duration of previously inserted SEMS was 170.6 days. Endoscopic revision (76.3%) or percutaneous revision (23.7%) was performed to resolve the occlusion. Clinical success rate of the primary revision was 44.7% and the mean patent duration was turned out to be 50.8 days. Twenty-four patients received second revision and 15 patients underwent third revision thereafter. Mean follow-up duration was 281.6 days after bilateral SEMS insertion and 120.2 days after primary revision. Comparing the revision method, clinical success rate was comparable between endoscopic revision and percutaneous revision (44.8% vs. 44.4%, pZ0.577). The patent duration after revision was 49.1 days in the endoscopic revision group and 56.3 days in the percutaneous revision group (pZ0.774). Conclusions: Palliative bilateral SEMS insertion was effective for unresectable malignant hilar biliary obstruction, however the efficacy and patency of occluded bilateral SEMS was not satisfactory. Endoscopic revision is preferred for the convenience of patients.
Tu1461 Prospective Molecular Mutational Analysis of Stent Supernatant in the Characterization of Benign and Malignant Biliary Strictures, an Interim Analysis Sunil Dacha*1, Jennifer Sprague3, Nicole Toney2, Steven Keilin1, Qiang Cai1, Field F. Willingham1 1 Dept. of Medicine, Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA; 2Interpace Diagnostics, Pittsburgh, PA; 3 Interpace Diagnostics, Pittsburgh, PA Introduction: The sensitivity of traditional modalities such as brush cytology in differentiating benign from malignant biliary strictures has been low in reported
www.giejournal.org
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB637
criteria in high risk for choledocholithiasis or intermediate risk with demonstrated CBDS by any diagnostic image as transabdominal ultrasound, biliary magnetic resonance (MRI) and biliopancreatic endoscopic ultrasonography (EUS). Results: We identified CBDS in 571 patients post ERCP (74,05%). We performed a bivariate analysis by age, classifying patients in 2 groups: those over 50 years (nZ499) and those under 50 years (nZ272). Also, we identified CBDS in 69% of patients under 50 years old and 77% in those over 50 years old. Other variables evaluated were: time of performing ERCP since emergency admission, jaundice, pancreatitis, cholangitis, prior cholecystectomy. Patients with positive ERCP findings have twice jaundice and more rates of acute cholangitis. Patients with acute pancreatitis, low alkaline phosphatase levels had more rates of ERCP negative findings. Patients with previous cholecystectomy had more rates of ERCP negative findings. (25% positive CBDS). 126 patients (63%) with ERCP negative findings were previously classified as high risk for choledocholithiasis based on liver enzymes and CBD diameter (non- MRI, non-EUS). Conclusion: Time between admission and ERCP findings could influence in CBDS probability. Acute pancreatitis and total bilirubin were not a strong predictor for CBSD. Some patients with ERCP negative findings were classified in high risk CBSD without confirmatory images. Maybe in these cases, the most significant criteria used to perform ERCP were bilirubin levels. Current criteria to predict CBDS using only laboratory tests and CBD diameter, overestimates risk, especially patients with previous cholecystectomy. So we propose in this scenario perform confirmatory image tests.
Tu1460 Revision of Bilateral Self-Expandable Metallic Stents for Malignant Hilar Biliary Obstruction Jun Hyuk Son*1, Sang Hyub Lee1, Hee Seung Lee2, Seungmin Bang2, Jinwoo Kang1, Jae Woo Lee1, Ji Kon Ryu1, Yong-Tae Kim1 1 Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea (the Republic of); 2 Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea (the Republic of)
trials and in clinical practice. Free DNA may be found in the cellular environment of neoplastic tissues due to rapid cell turn over and as a consequence of progressive mutational acquisition. However, the ability to obtain DNA from the supernatant of extracted stents and the performance of mutational analysis in distinguishing benign from malignant strictures has not been described. Methods: This study is an ongoing, prospective, controlled, single-blinded trial. An interim analysis was prespecified at accrual of 4 patients in each arm. Patients with known benign (post liver transplant anastomotic strictures) and known malignant strictures were enrolled. Plastic biliary stents extracted from patients during ERCP were sent for evaluation (Interpace Diagnostic, Pittsburgh, PA). The reference laboratory was blinded to the clinical history of the patient and the characterization of the stricture as benign or malignant. DNA was extracted from aliquots (supernatant, supernatant plus cells, cells, supernatant from stent) (Qiagen, Valencia, CA) and was quantified by optical density (NanoDrop, Thermo Scientific, Wilmington, DE). Quantitative PCR was used to establish the diagnostic yield. A validated panel included DNA markers for KRAS oncogene mutations and tumor suppressor gene loss-of-heterozygosity (LOH) mutations at 10 genomic loci. The presence or absence of KRAS mutations was examined in codons 12 and 13. Tumor suppressor gene LOH mutations were assessed at 10 loci via capillary gel electrophoresis: 1p (CMM1, Lmyc), 3p (VHL, OGG1), 5q (MCC, APC), 9p (CDKN2A, CDKN2B), 10q (PTEN, MXI1), 17p (TP53), 17q (NME1, RNF34), 18q (SMAD4, DCC), 21q (TFF1, PSEN2), and 22q (NF2). Results: Eight patients were included in the pre-specified interim analysis. Four patients with orthotropic liver transplantation had a known benign biliary anastomotic stricture and four patients had malignant biliary stricture. Mean age was 70.8+/-5.3 yrs. There were two male and six female patients. Mean AST was 112.2+/- 82.1U/L, mean ALT was 146.4+/-178.8 U/L, mean ALP was 452.7+/-334.7 U/L and total bilirubin was 8+/7.9 mg/dl. The supernatant and the KRAS performed with a very high specificity (100%) and a moderate sensitivity (50%); complete mutational analysis (Table 1). Conclusion: Stent supernatant fluid contains analyzable material, which is suitable for molecular characterization. The supernatant and the KRAS mutation analyses performed with very high specificity (100%) and moderate sensitivity (50%) in a small cohort. This interim analysis suggests that the stent supernatant analysis may be a promising adjunct to the low discriminatory capability of brush cytology for biliary strictures.
Background/Aims: Endoscopic biliary decompression using bilateral self-expandable metallic stents (SEMS) is considered as a favorable procedure for unresectable malignant hilar biliary obstruction. However occlusion of the bilateral SEMS is frequently occurred and revision can be challenging. This study was performed to evaluate the efficacy and the long-term patency of revision of bilateral SEMS and to investigate which revision method had better patency, endoscopic or percutaneous in patients with malignant hilar biliary obstruction. Methods: From January 2011 to July 2016, ninety-one patients with hilar biliary obstruction underwent endoscopic bilateral SEMS insertion in two tertiary hospitals located in South Korea. Among 91 patents, 74 patients were followed-up more than 30 days. We retrospectively reviewed the medical records. Results: Of the seventy-four patients, 38 experienced occlusion of previously inserted SEMS and underwent revision. Mean age of the patients was 69.2 years. The most common etiology of hilar biliary obstruction was cholangiocarcinoma (52.6%), followed by gallbladder cancer (34.2%) and the other metastatic cancer (13.2%). The mean patent duration of previously inserted SEMS was 170.6 days. Endoscopic revision (76.3%) or percutaneous revision (23.7%) was performed to resolve the occlusion. Clinical success rate of the primary revision was 44.7% and the mean patent duration was turned out to be 50.8 days. Twenty-four patients received second revision and 15 patients underwent third revision thereafter. Mean follow-up duration was 281.6 days after bilateral SEMS insertion and 120.2 days after primary revision. Comparing the revision method, clinical success rate was comparable between endoscopic revision and percutaneous revision (44.8% vs. 44.4%, pZ0.577). The patent duration after revision was 49.1 days in the endoscopic revision group and 56.3 days in the percutaneous revision group (pZ0.774). Conclusions: Palliative bilateral SEMS insertion was effective for unresectable malignant hilar biliary obstruction, however the efficacy and patency of occluded bilateral SEMS was not satisfactory. Endoscopic revision is preferred for the convenience of patients.
Tu1461 Prospective Molecular Mutational Analysis of Stent Supernatant in the Characterization of Benign and Malignant Biliary Strictures, an Interim Analysis Sunil Dacha*1, Jennifer Sprague3, Nicole Toney2, Steven Keilin1, Qiang Cai1, Field F. Willingham1 1 Dept. of Medicine, Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA; 2Interpace Diagnostics, Pittsburgh, PA; 3 Interpace Diagnostics, Pittsburgh, PA Introduction: The sensitivity of traditional modalities such as brush cytology in differentiating benign from malignant biliary strictures has been low in reported
www.giejournal.org
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB637