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Sa1104 Evaluation of a Novel Colonoscope Offering Flexibility Adjuster and a Multi-Led Technology
Abstracts
Sa1103 Analysis of the Factors Related to the Poor Outcome After E-Learning Training in Endoscopic Diagnosis of Early Gastric Cancer Using Magnifying Narrow-Band Imaging: A Post-Hoc Analysis Hisatomo Ikehara*1, Hisashi Doyama2, Hiroyoshi Nakanishi2, Takuji Gotoda1, Hideki Ishikawa3, Kenshi Yao4 1 Division of Gastroenterology and Hepatology, Nihon University School of Medicine, Tokyo, Japan; 2Department of Gastroenterology, Ishikawa prefectural central hospital, Ishikawa, Japan; 3Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan; 4Department of Endoscopy, Fukuoka University Chikushi Hospital, Fukuoka, Japan Background and Aims: Magnifying endoscopy with narrow-band imaging (M-NBI) is a recently developed image-enhanced endoscopic technique. For M-NBI diagnosis of early gastric cancer (EGC), the vessel plus surface classification system (VSCS) [1] has prospectively proven to be quite useful in distinguishing between EGC and noncancer. We have developed an e-learning system to teach endoscopic diagnosis of EGC using M-NBI based on VSCS, and proven its efficacy to improve the diagnostic performance for EGC (UMIN-CTR 000008569). However, some lesions were difficult to diagnose even after the e-learning training. The aim of this study was to assess the factors related to the poor learning outcome in M-NBI diagnosis. Methods: This study was a post-hoc analysis of a multicenter randomized controlled study. A total of 391 endoscopists underwent a diagnostic test, consisting only of M-NBI images of 40 gastric lesions, after e-learning. A diagnostic score of <70% after e-learning was defined as a poor learning outcome, compared with a diagnostic score of 70% using the following items: pathology (cancer/noncancer), size (10/<10mm), macroscopic type (elevated/flat-depressed), white opaque substance (WOS [2]) (positive/negative), demarcation line (DL) (easy/difficult), microvascular (MV) pattern (easy/difficult), and microsurface (MS) pattern (easy/difficult). Judgment whether DL, MV pattern and MS pattern were easy or difficult was independently decided by two experienced endoscopists. These analyses were also evaluated separately for cancer (22 cases) and noncancer (18 cases). Results: Univariate analysis showed that the difficult MV pattern and difficult MS pattern were significantly lower in accuracy (P<0.001, PZ0.001, respectively). Multivariate analysis showed that the difficult MV pattern had a significant impact on the poor learning outcome (PZ 0.002). For the cancerous lesions, the difficult MV pattern, difficult MS pattern, and positive WOS were associated with the poor learning outcome in univariate analysis (PZ0.03, PZ0.003, PZ0.07, respectively). Additionally, the positive WOS was associated with the poor learning outcome in multivariate analysis (PZ0.05). For the noncancerous lesions, the difficult MV pattern was the only significant factor in univariate analysis (PZ0.003). Conclusion: For the M-NBI diagnosis of gastric lesions, the difficult MV pattern was an important factor related to the poor learning outcome. Especially for gastric cancer, the positive WOS may also be involved. To improve the e-learning system further, we need to place greater emphasis on the MV pattern and WOS content. [1] Yao K et al. Endoscopy 2009;41:462-7. [2] Yao K et al. Gastrointest Endosc 2008;68:574-80.
Representative cancerous image of the poor learning outcome; The easy microvascular pattern and difficult microsurface pattern.
Representative noncancerous image of the poor learning outcome; the difficult microvascular pattern and difficult microsurface pattern.
Sa1104 Evaluation of a Novel Colonoscope Offering Flexibility Adjuster and a Multi-Led Technology Helmut Neumann*1, Helmut Neumann2, Khan Fareed Rahman1, Florian Thieringer1, Peter R. Galle1 1 University Medical Center Mainz, Mainz, Germany; 2Praxis, Bad Salzuflen, Germany Objectives: Colonoscopy is the gold standard for colorectal cancer screening. However, total colonoscopy may be somehow difficult according to loops preventing
AB192 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S : 2017
www.giejournal.org
Abstracts
advancement of the endoscope. Variable stiffness colonoscopes allow for passage of the rectosigmoid colon in a flexible mode followed by stiffing the device to prevent looping thus potentially accelerating the endoscopic procedure. Aims: Primary objective was to evaluate the performance characteristics of a novel colonoscope offering a new type of variable stiffness and a multi-LED technology. Material & Methods: Consecutive patients without previous colorectal surgery were prospectively included. Colonoscopy was performed with the new colonoscope and performance characteristics including time to cecum, withdrawal time, total examination time, patient and endoscopists’ satisfaction were recorded. Results: Among 180 consecutive procedures, 98.3% of examinations were complete to the cecum. Endoscopic flexibility adjuster was activated in 83.3% of cases. For the first 11 cases the device was judged as very helpful in 64% of examinations. In the following cases the device was always judged as very helpful suggesting a distinct learning curve. Mean cecal intubation time was 6.5 minutes with 35% of examination within less than 5 minutes and mean withdrawal time was 7 minutes. Mean total examination time was 18 minutes. Patient satisfaction was rated as high in all examination performed. Conclusion: The new variable stiffness colonoscope with a multi-LED technology allowed for fast and successful cecal intubation within a short period of time and was frequently judged as most helpful by the examiner. Future studies should now focus on the effect of the new colonoscope in unsedated patients.
Sa1105 Learning Curve for Optical Diagnosis of Colorectal Polyps Using Cumulative Sum Analysis Rameshshanker Rajaratnam*1,2, Ana Wilson1, Siwan Thomas-Gibson1, Nuala R. O’Shea1, Abdulkani Yusuf1, Brian P. Saunders1 1 Wolfson Unit for Endoscopy, St Mark’s Hospital, London, United Kingdom; 2Cancer and Surgery, Imperial College London, London, United Kingdom Introduction: Optical diagnosis (OD) for diminutive and small colorectal polyps is an attractive option to reduce costs and streamline patient care. The American Society of Gastrointestinal Endoscopy Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) established a 90% diagnostic threshold for real time endoscopic assessment of the histology of diminutive colorectal polyps. For adoption of optical diagnosis in clinical practice, colonoscopists must be trained and show on-going competence. The learning curve for trainees to achieve the competency has not been fully explored. Aims: To evaluate the minimum number of polyps to achieve and maintain the OD thresholds per PIVI standards using an upward CUSUM plot. Methods: Four trainees without previous experience in OD at our institution participated in this prospective study. 4 weeks before the commencement of the study they were given a training module on OD. OD was based on NICE and WASP classification.1,2 During the study period (January-August 2016), each trainee documented the OD of small polyps (<10mm). Confidence levels of OD were noted at the same time. Patient demographics and polyp details (site, size, Paris classification and histology) were collected prospectively. OD of each polyp was compared against the polyp histology. Polyps without the histological confirmation were excluded from the analysis. Every trainee had on-going feedback on their performance. Results: A total of 708 polyp observations were performed by trainees. Total number of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps (SSA/P) were 364,214 and 52 respectively. All 4 trainees achieved sustained accuracy (90% threshold) in OD within 12-58 observations. Image 1 illustrates the upward CUSUM plot of 4 trainees. The number of polyps required to reach the plateau varied between 12 to 58. Every trainee’s confidence level improved over time (from 69% to 89%) and the effect was augmented by in-vivo feedback and revision of training module. Table 1 summarises the optical diagnostic performance of all 4 trainees. Negative predictive value for adenomas were above 90% for all trainees. Conclusion: The CUSUM scores of all 4 trainees in the study reached the PIVI standards plateau by the 58th polyp observation. In-vivo feedback and continued training appears important to maintain the performance. Our preliminary findings could be used as a guide to plan the certification process for implementation of optical diagnosis. References Hewett DG et al. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow band imaging. Gastroenterology.2012;143(3):599-607. IJspeert JE et al. Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/ polyps. Gut 2016;65(6):963-70.
Trainees optical diagnostic performance Sensitivity Specificity Positive Predictive Value Negative Predictive Value
www.giejournal.org
Trainee 1
Trainee 2
Trainee 3
Trainee 4
95% 91% 89% 92%
96% 87% 94% 92%
94% 83% 88% 91%
92% 91% 94% 93%
Image 1: CUSUM plot of 4 trainees’ performance A - Number of polyps needed to achieve a plateau. B - In-vivo feedback
Sa1106 Topography of Intestinal Metaplasia and Dysplasia in Barrett’s Esophagus Wladyslaw Januszewicz*1,2, Andrzej Bielasik2, Janina Orlowska3, Anna Nasierowska-Guttmejer3, Jaroslaw Regula1,2 1 Gastrointestinal Oncology, the Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Mazowieckie, Poland; 2Department of Gastroenterology, Hepatology and Clinical Oncology, Medical Centre for Postgraduate Education, Warsaw, Mazowieckie, Poland; 3Department of Pathology and Diagnostic Laboratory, the Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Mazowieckie, Poland Background: Barrett’s Esophagus (BE) is a major risk factor for esophageal adenocarcinoma (EAC). Presence of intestinal metaplasia (IM) within the columnar lined esophagus is required to establish the diagnosis of BE and dysplasia is the best predictor of cancer progression in BE patients, however little is known about the distribution of IM and dysplasia within the columnar lined esophagus. Aim: To identify the distribution of the IM and dysplasia within BE segments. Methods: The study was a part of a prospective randomized trial comparing high resolution endoscopy with indigo carmine staining and targeted biopsy (HRIC) with standard endoscopy with 4-quadrant random biopsy (STD) in finding IM, dysplasia and cancer in BE. Patients were recruited from Polish Barrett’s Esophagus Registry (POBER) and were examined two times in cross-over fashion in sequence: STD and HRIC. Each specimen was taken into separate container and described according to distance from the upper limit of the gastric folds (ULGF) and analyzed by two independent expert histopathologist who were blinded to the origin of biopsies. Areas of BE were described as segment I for distance 0 to 2 cm from ULGF, segment II for areas between 2 to 4 cm from ULGF, segment III for areas between 4 to 6 cm from ULGF and segment IV for areas 6 cm from ULGF. The prevalence differences for IM and dysplasia depending on the standardized location of biopsies and frequency of diagnosis of dysplasia depending on the extent of IM were analyzed. The extent of IM was considered focal when it was present in less than 5 mucosal crypts in a single biopsy specimen and diffuse when it was present in more than 5 crypts. Results: 54 patients were included in the study [43 men (79.6%), median age 61 years (IQR:5471), median BMI 25.6 (IQR: 23,9-27,8)] of which 29 had long segment BE (53.7%). In total 565 biopsy samples, IM was present in 58 out of 261 samples (22.2%) taken in BE segment I, 79 of 146 (54.1%) in BE segment II, 68 of 90 (75.6%) in BE segment III and 55 of 68 (80.9%) in BE segment IV (p<0.001). Indefinite or low grade dysplasia was found in 18 biopsies (6.9%) taken in segment I and 71 biopsies (23.3%) taken in more proximal segments (II-IV) (p<0.001). High-grade dysplasia and cancer were found in 2 biopsies (0.8%) in segment I and 7 biopsies in more proximal segments (II-IV) (pZ0.13). Focal and diffuse IM were found in 11 (20.4%) and 41 (75.9%) patients respectively. Among patients with dysplasia or cancer 13.2% had focal IM and 86.8% had diffuse IM (pZ0.026). Conclusions: IM is localized most often in the most proximal part of BE, but in case of dysplasia such relation was not confirmed. Dysplasia and cancer develops more frequently in patients with diffuse IM than with focal IM.
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB193
Sa1103 Analysis of the Factors Related to the Poor Outcome After E-Learning Training in Endoscopic Diagnosis of Early Gastric Cancer Using Magnifying Narrow-Band Imaging: A Post-Hoc Analysis Hisatomo Ikehara*1, Hisashi Doyama2, Hiroyoshi Nakanishi2, Takuji Gotoda1, Hideki Ishikawa3, Kenshi Yao4 1 Division of Gastroenterology and Hepatology, Nihon University School of Medicine, Tokyo, Japan; 2Department of Gastroenterology, Ishikawa prefectural central hospital, Ishikawa, Japan; 3Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan; 4Department of Endoscopy, Fukuoka University Chikushi Hospital, Fukuoka, Japan Background and Aims: Magnifying endoscopy with narrow-band imaging (M-NBI) is a recently developed image-enhanced endoscopic technique. For M-NBI diagnosis of early gastric cancer (EGC), the vessel plus surface classification system (VSCS) [1] has prospectively proven to be quite useful in distinguishing between EGC and noncancer. We have developed an e-learning system to teach endoscopic diagnosis of EGC using M-NBI based on VSCS, and proven its efficacy to improve the diagnostic performance for EGC (UMIN-CTR 000008569). However, some lesions were difficult to diagnose even after the e-learning training. The aim of this study was to assess the factors related to the poor learning outcome in M-NBI diagnosis. Methods: This study was a post-hoc analysis of a multicenter randomized controlled study. A total of 391 endoscopists underwent a diagnostic test, consisting only of M-NBI images of 40 gastric lesions, after e-learning. A diagnostic score of <70% after e-learning was defined as a poor learning outcome, compared with a diagnostic score of 70% using the following items: pathology (cancer/noncancer), size (10/<10mm), macroscopic type (elevated/flat-depressed), white opaque substance (WOS [2]) (positive/negative), demarcation line (DL) (easy/difficult), microvascular (MV) pattern (easy/difficult), and microsurface (MS) pattern (easy/difficult). Judgment whether DL, MV pattern and MS pattern were easy or difficult was independently decided by two experienced endoscopists. These analyses were also evaluated separately for cancer (22 cases) and noncancer (18 cases). Results: Univariate analysis showed that the difficult MV pattern and difficult MS pattern were significantly lower in accuracy (P<0.001, PZ0.001, respectively). Multivariate analysis showed that the difficult MV pattern had a significant impact on the poor learning outcome (PZ 0.002). For the cancerous lesions, the difficult MV pattern, difficult MS pattern, and positive WOS were associated with the poor learning outcome in univariate analysis (PZ0.03, PZ0.003, PZ0.07, respectively). Additionally, the positive WOS was associated with the poor learning outcome in multivariate analysis (PZ0.05). For the noncancerous lesions, the difficult MV pattern was the only significant factor in univariate analysis (PZ0.003). Conclusion: For the M-NBI diagnosis of gastric lesions, the difficult MV pattern was an important factor related to the poor learning outcome. Especially for gastric cancer, the positive WOS may also be involved. To improve the e-learning system further, we need to place greater emphasis on the MV pattern and WOS content. [1] Yao K et al. Endoscopy 2009;41:462-7. [2] Yao K et al. Gastrointest Endosc 2008;68:574-80.
Representative cancerous image of the poor learning outcome; The easy microvascular pattern and difficult microsurface pattern.
Representative noncancerous image of the poor learning outcome; the difficult microvascular pattern and difficult microsurface pattern.
Sa1104 Evaluation of a Novel Colonoscope Offering Flexibility Adjuster and a Multi-Led Technology Helmut Neumann*1, Helmut Neumann2, Khan Fareed Rahman1, Florian Thieringer1, Peter R. Galle1 1 University Medical Center Mainz, Mainz, Germany; 2Praxis, Bad Salzuflen, Germany Objectives: Colonoscopy is the gold standard for colorectal cancer screening. However, total colonoscopy may be somehow difficult according to loops preventing
AB192 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S : 2017
www.giejournal.org
Abstracts
advancement of the endoscope. Variable stiffness colonoscopes allow for passage of the rectosigmoid colon in a flexible mode followed by stiffing the device to prevent looping thus potentially accelerating the endoscopic procedure. Aims: Primary objective was to evaluate the performance characteristics of a novel colonoscope offering a new type of variable stiffness and a multi-LED technology. Material & Methods: Consecutive patients without previous colorectal surgery were prospectively included. Colonoscopy was performed with the new colonoscope and performance characteristics including time to cecum, withdrawal time, total examination time, patient and endoscopists’ satisfaction were recorded. Results: Among 180 consecutive procedures, 98.3% of examinations were complete to the cecum. Endoscopic flexibility adjuster was activated in 83.3% of cases. For the first 11 cases the device was judged as very helpful in 64% of examinations. In the following cases the device was always judged as very helpful suggesting a distinct learning curve. Mean cecal intubation time was 6.5 minutes with 35% of examination within less than 5 minutes and mean withdrawal time was 7 minutes. Mean total examination time was 18 minutes. Patient satisfaction was rated as high in all examination performed. Conclusion: The new variable stiffness colonoscope with a multi-LED technology allowed for fast and successful cecal intubation within a short period of time and was frequently judged as most helpful by the examiner. Future studies should now focus on the effect of the new colonoscope in unsedated patients.
Sa1105 Learning Curve for Optical Diagnosis of Colorectal Polyps Using Cumulative Sum Analysis Rameshshanker Rajaratnam*1,2, Ana Wilson1, Siwan Thomas-Gibson1, Nuala R. O’Shea1, Abdulkani Yusuf1, Brian P. Saunders1 1 Wolfson Unit for Endoscopy, St Mark’s Hospital, London, United Kingdom; 2Cancer and Surgery, Imperial College London, London, United Kingdom Introduction: Optical diagnosis (OD) for diminutive and small colorectal polyps is an attractive option to reduce costs and streamline patient care. The American Society of Gastrointestinal Endoscopy Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) established a 90% diagnostic threshold for real time endoscopic assessment of the histology of diminutive colorectal polyps. For adoption of optical diagnosis in clinical practice, colonoscopists must be trained and show on-going competence. The learning curve for trainees to achieve the competency has not been fully explored. Aims: To evaluate the minimum number of polyps to achieve and maintain the OD thresholds per PIVI standards using an upward CUSUM plot. Methods: Four trainees without previous experience in OD at our institution participated in this prospective study. 4 weeks before the commencement of the study they were given a training module on OD. OD was based on NICE and WASP classification.1,2 During the study period (January-August 2016), each trainee documented the OD of small polyps (<10mm). Confidence levels of OD were noted at the same time. Patient demographics and polyp details (site, size, Paris classification and histology) were collected prospectively. OD of each polyp was compared against the polyp histology. Polyps without the histological confirmation were excluded from the analysis. Every trainee had on-going feedback on their performance. Results: A total of 708 polyp observations were performed by trainees. Total number of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps (SSA/P) were 364,214 and 52 respectively. All 4 trainees achieved sustained accuracy (90% threshold) in OD within 12-58 observations. Image 1 illustrates the upward CUSUM plot of 4 trainees. The number of polyps required to reach the plateau varied between 12 to 58. Every trainee’s confidence level improved over time (from 69% to 89%) and the effect was augmented by in-vivo feedback and revision of training module. Table 1 summarises the optical diagnostic performance of all 4 trainees. Negative predictive value for adenomas were above 90% for all trainees. Conclusion: The CUSUM scores of all 4 trainees in the study reached the PIVI standards plateau by the 58th polyp observation. In-vivo feedback and continued training appears important to maintain the performance. Our preliminary findings could be used as a guide to plan the certification process for implementation of optical diagnosis. References Hewett DG et al. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow band imaging. Gastroenterology.2012;143(3):599-607. IJspeert JE et al. Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/ polyps. Gut 2016;65(6):963-70.
Trainees optical diagnostic performance Sensitivity Specificity Positive Predictive Value Negative Predictive Value
www.giejournal.org
Trainee 1
Trainee 2
Trainee 3
Trainee 4
95% 91% 89% 92%
96% 87% 94% 92%
94% 83% 88% 91%
92% 91% 94% 93%
Image 1: CUSUM plot of 4 trainees’ performance A - Number of polyps needed to achieve a plateau. B - In-vivo feedback
Sa1106 Topography of Intestinal Metaplasia and Dysplasia in Barrett’s Esophagus Wladyslaw Januszewicz*1,2, Andrzej Bielasik2, Janina Orlowska3, Anna Nasierowska-Guttmejer3, Jaroslaw Regula1,2 1 Gastrointestinal Oncology, the Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Mazowieckie, Poland; 2Department of Gastroenterology, Hepatology and Clinical Oncology, Medical Centre for Postgraduate Education, Warsaw, Mazowieckie, Poland; 3Department of Pathology and Diagnostic Laboratory, the Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Mazowieckie, Poland Background: Barrett’s Esophagus (BE) is a major risk factor for esophageal adenocarcinoma (EAC). Presence of intestinal metaplasia (IM) within the columnar lined esophagus is required to establish the diagnosis of BE and dysplasia is the best predictor of cancer progression in BE patients, however little is known about the distribution of IM and dysplasia within the columnar lined esophagus. Aim: To identify the distribution of the IM and dysplasia within BE segments. Methods: The study was a part of a prospective randomized trial comparing high resolution endoscopy with indigo carmine staining and targeted biopsy (HRIC) with standard endoscopy with 4-quadrant random biopsy (STD) in finding IM, dysplasia and cancer in BE. Patients were recruited from Polish Barrett’s Esophagus Registry (POBER) and were examined two times in cross-over fashion in sequence: STD and HRIC. Each specimen was taken into separate container and described according to distance from the upper limit of the gastric folds (ULGF) and analyzed by two independent expert histopathologist who were blinded to the origin of biopsies. Areas of BE were described as segment I for distance 0 to 2 cm from ULGF, segment II for areas between 2 to 4 cm from ULGF, segment III for areas between 4 to 6 cm from ULGF and segment IV for areas 6 cm from ULGF. The prevalence differences for IM and dysplasia depending on the standardized location of biopsies and frequency of diagnosis of dysplasia depending on the extent of IM were analyzed. The extent of IM was considered focal when it was present in less than 5 mucosal crypts in a single biopsy specimen and diffuse when it was present in more than 5 crypts. Results: 54 patients were included in the study [43 men (79.6%), median age 61 years (IQR:5471), median BMI 25.6 (IQR: 23,9-27,8)] of which 29 had long segment BE (53.7%). In total 565 biopsy samples, IM was present in 58 out of 261 samples (22.2%) taken in BE segment I, 79 of 146 (54.1%) in BE segment II, 68 of 90 (75.6%) in BE segment III and 55 of 68 (80.9%) in BE segment IV (p<0.001). Indefinite or low grade dysplasia was found in 18 biopsies (6.9%) taken in segment I and 71 biopsies (23.3%) taken in more proximal segments (II-IV) (p<0.001). High-grade dysplasia and cancer were found in 2 biopsies (0.8%) in segment I and 7 biopsies in more proximal segments (II-IV) (pZ0.13). Focal and diffuse IM were found in 11 (20.4%) and 41 (75.9%) patients respectively. Among patients with dysplasia or cancer 13.2% had focal IM and 86.8% had diffuse IM (pZ0.026). Conclusions: IM is localized most often in the most proximal part of BE, but in case of dysplasia such relation was not confirmed. Dysplasia and cancer develops more frequently in patients with diffuse IM than with focal IM.
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB193