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T1212 Diagnostic Efficacy of Standard ERCP and Directed Spybite® Biopsies in Patients With Suspected Bile Duct Strictures
AGA Abstracts
p21Rac-dependent signalling and suggest that activation of the p21Rac pathway is essential for sustaining colonic inflammation in CD. These results establish the potential of kinome profiling for enhancing our understanding of human pathology and help identify relevant clinical targets in human disease.
was to determine whether FDG-PET is able to differentiate between responding and nonresponding oesophageal tumours early in the course of neoadjuvant chemoradiotherapy. Methods: Serial FDG-PET before and after 2 weeks of neoadjuvant therapy was be performed in the multimodality treatment arm (concurrent Carboplatin/Paclitaxel and 41.4Gy radiotherapy in 23 fractions) of a multicentre randomized controlled trial including patients with potentially curable oesophageal carcinoma. FDG uptake was expressed as the Standardized Uptake Value and corrected for body weight and glucose level. Resection specimens were assessed for tumour response using the Mandard score. Responders were defined as score 1 or 2 (no or <10% viable tumour cells). ROC analysis was used to determine optimal cutoff values and consequently calculate diagnostic parameters. Results: A total of 100 patients were used for PET response analysis, of whom 64 patients were histopathological responders and 36 were non-responders. Median SUV decrease between PET before and after 14 days of therapy was 30.9% for histopathological responders and 1.7% for non-responders (p= 0.001). With a 20% SUV decrease as cut-off value for detection of histopathological response, PET identified 58 patients as responder: 45 correctly and 13 incorrectly. A total of 42 patients were identified as non-responders by PET: 23 correctly and 19 incorrectly. Diagnostic parameters for detecting histopathological responders by using PET were: sensitivity 70%, specificity 64%, positive predictive value 78% and negative predictive value 55%. Conclusion: SUV decrease as measured by PET before and after 14 days of chemoradiotherapy is significantly associated with histopathological tumour response but showed a limited accuracy. The negative predictive value was too low to justify early discontinuation of neoadjuvant chemoradiotherapy in patients with oesophageal cancer based on response as measured by FDG PET.
T1209 Outcomes and Predictors of Response to Endoscopic Sclerotherapy for Treatment of Weight Regain After Roux-en-Y Gastric Bypass Surgery Barham K. Abu Dayyeh, Christopher C. Thompson Background: Weight regain after Roux-en-Y gastric bypass (RYGB) occurs in about 20%30% of patients, and is associated with significant morbidity and mortality. Therapeutic options are limited, and revision RYGB surgery carries high morbidity and mortality. Here we report outcomes and significant predictors of response to sclerotherapy as a treatment for weight regain after RYGB surgery. Methods: 53 consecutive patients who underwent sclerotherapy for weight regain after RYGB surgery between 2008- 2009 were included. Linear regression analysis was performed to identify significant clinical and endoscopic predictors. Results: The average age of subjects was 45 years, 88% females, 13% with diabetes, average weight loss after the RYGB was 117 lbs, and the average weight regain from nadir weight was 43 lbs. Mean time between RYGB and first sclerotherapy procedure was 5 years. Average gastrojejunal (GJ) stoma diameter prior to sclerotherapy was 21mm. On average, 41 mls of sodium morrhuate were injected over 2.4 endoscopy sessions. At 3 and 6 month follow-up after first sclerotherapy session the average GJ stoma diameter was 6 and 7 mm smaller, respectively. The average weight loss was 9 and 15 lbs at the same time points. 7% of subject developed post sclerotherapy abdominal pain not requiring hospitalization or narcotics use. 1 out of the 53 subjects was hospitalized with possible microperforation that was managed conservatively. The most significant univariate predictors of weight loss at 6 months after sclerotherapy were amount of weight regain from nadir weight after RYGB (pearson correlation = 0.6, p = 0.0007), and amount of weight lost at 3 months after first sclerotherapy session (pearson correlation = 0.9, p < 0.0001). In a multivariate model adjusted for age, sex, diabetes, amount of weight regain, number of sclerotherapy sessions, volume of sodium morrhuate used, GJ stoma diameter prior to sclerotherapy, and change in GJ stoma diameter at 3 and 6 months after - the two above predictors remained significant. In addition, the volume of sodium morrhuate injected became significant as well (β = 0.5, p = 0.02). Conclusion: Sclerotherapy is a safe and effective method of managing weight regain after RYGB surgery. Amount of weight regain from RYGB nadir, weight loss at 3 months after first sclerotherapy, and amount of sodium morrhuate injected are significant outcome predictors. Weight loss appears to be independent of changes in GJ stoma diameter.
T1212 Diagnostic Efficacy of Standard ERCP and Directed Spybite® Biopsies in Patients With Suspected Bile Duct Strictures Deborah Giusto, Douglas J. Hartman, Michael K. Sanders, Adam Slivka, Alyssa M. Krasinskas Background: Intraductal endoscopy is an integral part of the evaluation of patients with suspected biliary strictures. Both standard ERCP guided “random” biopsies and SpyGlass® directed SpyBite® biopsies are obtained at our institution. The aims of this study were to assess the diagnostic efficacy of these two techniques and to identify histologic features that may aid the pathologist in the diagnosis of malignancy. Methods: We retrospectively identified 21 patients with SpyBite biopsies and 50 patients with biopsies obtained during ERCP from patients who had suspected biliary strictures; 3 patients were in the SpyGlass Registry and 9 patients had concurrent bile duct biopsies using both ERCP and SpyGlass. Results: The mean total biopsy size was larger (0.58 cm) for ERCP biopsies compared to SpyBite biopsies (0.39 cm) (p=0.014). More of the SpyBite fragments consisted of detached epithelium (75% vs 56% for ERCP fragments; p<0.05), but there were similar amounts of epithelium, stroma and blood by each method. Two (4%) ERCP (vs 0 SpyBite) biopsies were insufficient. 18 (38%) and 30 (62%) cases of ERCP biopsies were diagnosed as malignant and benign, respectively. 5 (24%) and 16 (76%) cases of SpyBite biopsies were malignant and benign, respectively. The false negative rate was 11% for ERCP and 24% for SpyBite biopsies; the false positive rate was 0% for both. Sensitivity, specificity, positive predictive value, and negative predictive value of ERCP biopsies were 76%, 100%, 100% and 83%, respectively, and of SpyBite biopsies, 50%, 100%, 100% and 69%, respectively. Of note, 21 patients had concomitant bile duct brushings with a sensitivity of 33%. The biopsy results were discordant in 2 of the 9 patients who had both ERCP and SpyGlass exams; in 1 case, the ERCP biopsy was insufficient while the SpyBite biopsy was diagnostic, and in the other case, the ERCP biopsy was malignant while the SpyBite biopsy was benign. In the absence of stromal invasion, the histologic features associated with malignancy in the biopsies were irregular nuclear contours (90%), nuclear molding (80%), angulated nuclei (95%) and foamy cytoplasm (90%). Conclusion: Accurate diagnosis on bile duct biopsy is essential in managing patients with bile duct strictures, but the distinction between malignant and benign processes remains challenging. In our experience, both standard ERCP and directed SpyBite biopsies provide useful information, with an overall sensitivity of 68%. As pathologists gain more experience with small SpyBite biopsies and apply specific diagnostic criteria of malignancy, the diagnostic efficacy of intraductal biopsies will continue to improve.
T1210 Development of a New Electrochemical Device for Rapid Helicobacter pylori Detection Stefan Foertsch, Helmut Neumann, Michael Vieth, Dirk M. Guldi, Markus F. Neurath, Rainer Kuth Introduction: H. pylori-infection (H. pylori) is associated with various gastroduodenal pathologies ranging from gastritis, peptic ulcer disease to gastric cancer. The diagnosis of H. pylori is established using invasive or non-invasive methods. Nevertheless, time to reach final diagnosis is delayed because of definitive reconditioning of the respective samples. Aim: To develop a new electrochemical device for rapid H. pylori detection. Material & Methods: First, an amount of 60 sensors was manually manufactured. The sensor plate consists of an in-situ functionalised working electrode (silver/silver chloride) and a reference electrode (gold). Half of the sensors were used for tests with standardized bases (e.g. sodium hydroxide and ammonia) and acids (e.g. hydrochloric acid) to establish working standards. After establishment of the standards, the remaining sensors were used on adapted pig stomach biopsy samples which were simulating H. pylori infection of the human stomach. Sensor output was measured through a data receiver (Agilent U1252A, Agilent Technologies, Santa Clara, USA) over a period of 500 seconds. Acquired diagrams and voltage-values were analysed for characteristics typical for H. pylori infection. Results: A new electrochemical device for rapid H. pylori detection was developed. The test showed high accuracy (sensitivity 100%, specifity 100%) in the detection of H. pylori in an animal model. Sensors produced a clear and stable signal over time. Definitive results for H. pylori detection were achieved within 10 seconds. Conclusion: The results predict that the newly developed electrochemical device is a promising alternative to currently used H. pylori detection methods. Main advantages are the speed of the detection and the high accuracy, as well as the expected low prize of each test. Currently, the clinical reliability of the device is evaluated in an equivalence controlled trial in comparison to immunohistochemistry, Helicobacter urease test and 13C breath test.
T1213 Comparison of Tissue Architectural Changes Between Radiofrequency Ablation and Cryospray Ablation in Barrett's Esophagus Using Endoscopic Three-Dimensional Optical Coherence Tomography Tsung-Han Tsai, Chao Zhou, Hsiang-Chieh Lee, Walter W. Chan, Qin Huang, Marisa Figueiredo, Desmond C. Adler, Joseph M. Schmitt, James G. Fujimoto, Hiroshi Mashimo BACKGROUND/AIMS: Radiofrequency ablation (RFA) and cryospray ablation (CSA) are recently developed methods that utilize thermal gradients to treat dysplastic Barrett's esophagus (BE). Both allow broad and superficial treatment fields for BE without perforation or stricturing. We sought to assess whether post-ablation architectural distortions of esophageal tissues differ between these two therapies using endoscopic three-dimensional OCT (3DOCT). 3D-OCT is a volumetric imaging technique uniquely suited for In Vivo imaging of the esophagus, since it enables en face and cross-sectional evaluation of the entire ablated field. It can provide comparison of the structural changes or mucosal damages between RFA and CSA therapies. METHODS: Endoscopic 3D-OCT imaging was performed on 4 patients following RFA and 2 patients following CSA for BE. Imaging was performed before and immediately after therapy to record the treatment effect. 3D-OCT imaging was conducted with a spiral-scanning catheter introduced through the biopsy channel of the endoscope. 8 mm circumferential scans were acquired over an 18 mm pullback length with an imaging depth of 1.7 mm and optical resolution of ~5-10 μm. RFA and CSA were performed with the Barrx HALO90 system and CSA medical systems, respectively. Volumetric data sets were analyzed, and tissue morphological changes and their locations were recorded. RESULTS: In all patients post RFA therapy, burned tissues with hyperscattering feature in ~200 μm average depth range were observed in the treatment fields after the first RFA and an additional ~250 μm after the second RFA during each treatment session, yielding ~450 μm in total
T1211 Early Response Assessment of Neoadjuvant Therapy With Positron Emission Tomography in Patients With Oesophageal Cancer Mark van Heijl, Jikke M. Omloo, Mark I. van Berge Henegouwen, Otto S. Hoekstra, Ronald Boellaard, Patrick M. Bossuyt, Olivier R. Busch, Hugo W. Tilanus, Maarten C. Hulshof, Ate van der Gaast, Grard A. Nieuwenhuijzen, Han J. Bonenkamp, Jos W. van Loenhout, John T. Plukker, Miguel A. Cuesta, Fiebo J. ten Kate, Jan Pruim, Herman van Dekken, Jacques Bergman, Gerrit W. Sloof, Jan J. van Lanschot Background: In a proportion of patients with potentially curable oesophageal cancer, insufficient objective response on neoadjuvant chemoradiotherapy is achieved. These patients do not benefit from neoadjuvant therapy, but do suffer from toxic side effects and inevitable delay of appropriate surgical therapy. Metabolic imaging with Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) seems to be a promising modality to identify non-responders early during neoadjuvant chemoradiotherapy. Therefore, the aim of the present study
AGA Abstracts
S-512
p21Rac-dependent signalling and suggest that activation of the p21Rac pathway is essential for sustaining colonic inflammation in CD. These results establish the potential of kinome profiling for enhancing our understanding of human pathology and help identify relevant clinical targets in human disease.
was to determine whether FDG-PET is able to differentiate between responding and nonresponding oesophageal tumours early in the course of neoadjuvant chemoradiotherapy. Methods: Serial FDG-PET before and after 2 weeks of neoadjuvant therapy was be performed in the multimodality treatment arm (concurrent Carboplatin/Paclitaxel and 41.4Gy radiotherapy in 23 fractions) of a multicentre randomized controlled trial including patients with potentially curable oesophageal carcinoma. FDG uptake was expressed as the Standardized Uptake Value and corrected for body weight and glucose level. Resection specimens were assessed for tumour response using the Mandard score. Responders were defined as score 1 or 2 (no or <10% viable tumour cells). ROC analysis was used to determine optimal cutoff values and consequently calculate diagnostic parameters. Results: A total of 100 patients were used for PET response analysis, of whom 64 patients were histopathological responders and 36 were non-responders. Median SUV decrease between PET before and after 14 days of therapy was 30.9% for histopathological responders and 1.7% for non-responders (p= 0.001). With a 20% SUV decrease as cut-off value for detection of histopathological response, PET identified 58 patients as responder: 45 correctly and 13 incorrectly. A total of 42 patients were identified as non-responders by PET: 23 correctly and 19 incorrectly. Diagnostic parameters for detecting histopathological responders by using PET were: sensitivity 70%, specificity 64%, positive predictive value 78% and negative predictive value 55%. Conclusion: SUV decrease as measured by PET before and after 14 days of chemoradiotherapy is significantly associated with histopathological tumour response but showed a limited accuracy. The negative predictive value was too low to justify early discontinuation of neoadjuvant chemoradiotherapy in patients with oesophageal cancer based on response as measured by FDG PET.
T1209 Outcomes and Predictors of Response to Endoscopic Sclerotherapy for Treatment of Weight Regain After Roux-en-Y Gastric Bypass Surgery Barham K. Abu Dayyeh, Christopher C. Thompson Background: Weight regain after Roux-en-Y gastric bypass (RYGB) occurs in about 20%30% of patients, and is associated with significant morbidity and mortality. Therapeutic options are limited, and revision RYGB surgery carries high morbidity and mortality. Here we report outcomes and significant predictors of response to sclerotherapy as a treatment for weight regain after RYGB surgery. Methods: 53 consecutive patients who underwent sclerotherapy for weight regain after RYGB surgery between 2008- 2009 were included. Linear regression analysis was performed to identify significant clinical and endoscopic predictors. Results: The average age of subjects was 45 years, 88% females, 13% with diabetes, average weight loss after the RYGB was 117 lbs, and the average weight regain from nadir weight was 43 lbs. Mean time between RYGB and first sclerotherapy procedure was 5 years. Average gastrojejunal (GJ) stoma diameter prior to sclerotherapy was 21mm. On average, 41 mls of sodium morrhuate were injected over 2.4 endoscopy sessions. At 3 and 6 month follow-up after first sclerotherapy session the average GJ stoma diameter was 6 and 7 mm smaller, respectively. The average weight loss was 9 and 15 lbs at the same time points. 7% of subject developed post sclerotherapy abdominal pain not requiring hospitalization or narcotics use. 1 out of the 53 subjects was hospitalized with possible microperforation that was managed conservatively. The most significant univariate predictors of weight loss at 6 months after sclerotherapy were amount of weight regain from nadir weight after RYGB (pearson correlation = 0.6, p = 0.0007), and amount of weight lost at 3 months after first sclerotherapy session (pearson correlation = 0.9, p < 0.0001). In a multivariate model adjusted for age, sex, diabetes, amount of weight regain, number of sclerotherapy sessions, volume of sodium morrhuate used, GJ stoma diameter prior to sclerotherapy, and change in GJ stoma diameter at 3 and 6 months after - the two above predictors remained significant. In addition, the volume of sodium morrhuate injected became significant as well (β = 0.5, p = 0.02). Conclusion: Sclerotherapy is a safe and effective method of managing weight regain after RYGB surgery. Amount of weight regain from RYGB nadir, weight loss at 3 months after first sclerotherapy, and amount of sodium morrhuate injected are significant outcome predictors. Weight loss appears to be independent of changes in GJ stoma diameter.
T1212 Diagnostic Efficacy of Standard ERCP and Directed Spybite® Biopsies in Patients With Suspected Bile Duct Strictures Deborah Giusto, Douglas J. Hartman, Michael K. Sanders, Adam Slivka, Alyssa M. Krasinskas Background: Intraductal endoscopy is an integral part of the evaluation of patients with suspected biliary strictures. Both standard ERCP guided “random” biopsies and SpyGlass® directed SpyBite® biopsies are obtained at our institution. The aims of this study were to assess the diagnostic efficacy of these two techniques and to identify histologic features that may aid the pathologist in the diagnosis of malignancy. Methods: We retrospectively identified 21 patients with SpyBite biopsies and 50 patients with biopsies obtained during ERCP from patients who had suspected biliary strictures; 3 patients were in the SpyGlass Registry and 9 patients had concurrent bile duct biopsies using both ERCP and SpyGlass. Results: The mean total biopsy size was larger (0.58 cm) for ERCP biopsies compared to SpyBite biopsies (0.39 cm) (p=0.014). More of the SpyBite fragments consisted of detached epithelium (75% vs 56% for ERCP fragments; p<0.05), but there were similar amounts of epithelium, stroma and blood by each method. Two (4%) ERCP (vs 0 SpyBite) biopsies were insufficient. 18 (38%) and 30 (62%) cases of ERCP biopsies were diagnosed as malignant and benign, respectively. 5 (24%) and 16 (76%) cases of SpyBite biopsies were malignant and benign, respectively. The false negative rate was 11% for ERCP and 24% for SpyBite biopsies; the false positive rate was 0% for both. Sensitivity, specificity, positive predictive value, and negative predictive value of ERCP biopsies were 76%, 100%, 100% and 83%, respectively, and of SpyBite biopsies, 50%, 100%, 100% and 69%, respectively. Of note, 21 patients had concomitant bile duct brushings with a sensitivity of 33%. The biopsy results were discordant in 2 of the 9 patients who had both ERCP and SpyGlass exams; in 1 case, the ERCP biopsy was insufficient while the SpyBite biopsy was diagnostic, and in the other case, the ERCP biopsy was malignant while the SpyBite biopsy was benign. In the absence of stromal invasion, the histologic features associated with malignancy in the biopsies were irregular nuclear contours (90%), nuclear molding (80%), angulated nuclei (95%) and foamy cytoplasm (90%). Conclusion: Accurate diagnosis on bile duct biopsy is essential in managing patients with bile duct strictures, but the distinction between malignant and benign processes remains challenging. In our experience, both standard ERCP and directed SpyBite biopsies provide useful information, with an overall sensitivity of 68%. As pathologists gain more experience with small SpyBite biopsies and apply specific diagnostic criteria of malignancy, the diagnostic efficacy of intraductal biopsies will continue to improve.
T1210 Development of a New Electrochemical Device for Rapid Helicobacter pylori Detection Stefan Foertsch, Helmut Neumann, Michael Vieth, Dirk M. Guldi, Markus F. Neurath, Rainer Kuth Introduction: H. pylori-infection (H. pylori) is associated with various gastroduodenal pathologies ranging from gastritis, peptic ulcer disease to gastric cancer. The diagnosis of H. pylori is established using invasive or non-invasive methods. Nevertheless, time to reach final diagnosis is delayed because of definitive reconditioning of the respective samples. Aim: To develop a new electrochemical device for rapid H. pylori detection. Material & Methods: First, an amount of 60 sensors was manually manufactured. The sensor plate consists of an in-situ functionalised working electrode (silver/silver chloride) and a reference electrode (gold). Half of the sensors were used for tests with standardized bases (e.g. sodium hydroxide and ammonia) and acids (e.g. hydrochloric acid) to establish working standards. After establishment of the standards, the remaining sensors were used on adapted pig stomach biopsy samples which were simulating H. pylori infection of the human stomach. Sensor output was measured through a data receiver (Agilent U1252A, Agilent Technologies, Santa Clara, USA) over a period of 500 seconds. Acquired diagrams and voltage-values were analysed for characteristics typical for H. pylori infection. Results: A new electrochemical device for rapid H. pylori detection was developed. The test showed high accuracy (sensitivity 100%, specifity 100%) in the detection of H. pylori in an animal model. Sensors produced a clear and stable signal over time. Definitive results for H. pylori detection were achieved within 10 seconds. Conclusion: The results predict that the newly developed electrochemical device is a promising alternative to currently used H. pylori detection methods. Main advantages are the speed of the detection and the high accuracy, as well as the expected low prize of each test. Currently, the clinical reliability of the device is evaluated in an equivalence controlled trial in comparison to immunohistochemistry, Helicobacter urease test and 13C breath test.
T1213 Comparison of Tissue Architectural Changes Between Radiofrequency Ablation and Cryospray Ablation in Barrett's Esophagus Using Endoscopic Three-Dimensional Optical Coherence Tomography Tsung-Han Tsai, Chao Zhou, Hsiang-Chieh Lee, Walter W. Chan, Qin Huang, Marisa Figueiredo, Desmond C. Adler, Joseph M. Schmitt, James G. Fujimoto, Hiroshi Mashimo BACKGROUND/AIMS: Radiofrequency ablation (RFA) and cryospray ablation (CSA) are recently developed methods that utilize thermal gradients to treat dysplastic Barrett's esophagus (BE). Both allow broad and superficial treatment fields for BE without perforation or stricturing. We sought to assess whether post-ablation architectural distortions of esophageal tissues differ between these two therapies using endoscopic three-dimensional OCT (3DOCT). 3D-OCT is a volumetric imaging technique uniquely suited for In Vivo imaging of the esophagus, since it enables en face and cross-sectional evaluation of the entire ablated field. It can provide comparison of the structural changes or mucosal damages between RFA and CSA therapies. METHODS: Endoscopic 3D-OCT imaging was performed on 4 patients following RFA and 2 patients following CSA for BE. Imaging was performed before and immediately after therapy to record the treatment effect. 3D-OCT imaging was conducted with a spiral-scanning catheter introduced through the biopsy channel of the endoscope. 8 mm circumferential scans were acquired over an 18 mm pullback length with an imaging depth of 1.7 mm and optical resolution of ~5-10 μm. RFA and CSA were performed with the Barrx HALO90 system and CSA medical systems, respectively. Volumetric data sets were analyzed, and tissue morphological changes and their locations were recorded. RESULTS: In all patients post RFA therapy, burned tissues with hyperscattering feature in ~200 μm average depth range were observed in the treatment fields after the first RFA and an additional ~250 μm after the second RFA during each treatment session, yielding ~450 μm in total
T1211 Early Response Assessment of Neoadjuvant Therapy With Positron Emission Tomography in Patients With Oesophageal Cancer Mark van Heijl, Jikke M. Omloo, Mark I. van Berge Henegouwen, Otto S. Hoekstra, Ronald Boellaard, Patrick M. Bossuyt, Olivier R. Busch, Hugo W. Tilanus, Maarten C. Hulshof, Ate van der Gaast, Grard A. Nieuwenhuijzen, Han J. Bonenkamp, Jos W. van Loenhout, John T. Plukker, Miguel A. Cuesta, Fiebo J. ten Kate, Jan Pruim, Herman van Dekken, Jacques Bergman, Gerrit W. Sloof, Jan J. van Lanschot Background: In a proportion of patients with potentially curable oesophageal cancer, insufficient objective response on neoadjuvant chemoradiotherapy is achieved. These patients do not benefit from neoadjuvant therapy, but do suffer from toxic side effects and inevitable delay of appropriate surgical therapy. Metabolic imaging with Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) seems to be a promising modality to identify non-responders early during neoadjuvant chemoradiotherapy. Therefore, the aim of the present study
AGA Abstracts
S-512