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Mo1588 The New 360° Panoramic-Viewing Capsule Endoscopy System: Results of the First Multicenter, Observational, Study
Abstracts
high tendency in the SB3 group but there was no significance between the two groups. Conclusion: When we used the RAPID Readar8 and the SB3/DR3 recorder, the interpretation time of the SB2 plus group vs. the SB3 group reduced significantly, but no decrease was observed in the number of the thumbnails and the diagnostic contribution rate. Therefore, we considered that the efficiency of the small intestine capsule endoscopy was achieved by the RAPID Readar8 and the SB3/ DR3 recorder, which realized the possibility of reducing the burden of radiogram interpretation.
Mo1588 The New 360 Panoramic-Viewing Capsule Endoscopy System: Results of the First Multicenter, Observational, Study Gian Eugenio Tontini1, Flaminia Cavallaro1, Roberta Marino4, Mark E. Mcalindon7, Emanuele Rondonotti3, Anastasios Koulaouzidis6, Pasquale Vitagliano5, Luca Pastorelli*2,1, Maurizio Vecchi2,1 1 Gastroenterology & Digestive Endoscopy Unit, IRCCS Policlinico San Donato, San Donato Milanese, Italy; 2Department of Biomedical Sciences for Health, University of Milan, Milano, Italy; 3Gastroenterology Unit, Ospedale Valduce, Como, Italy; 4Gastroenterology and Digestive Endoscopy Unit, AO Lodi, Lodi, Italy; 5Digestive Endoscopy Unit, AO Melegnano, Melegnano, Italy; 6Gastroenterology and Digestive Endoscopy Unit, The Royal Infirmary of Edinburgh, Edinburgh, United Kingdom; 7Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
Background & Aims: CapsoCamÒ SV1 (CapsoVision Inc, Saratoga, USA) is a new small bowel capsule (SBC) with “panoramic lateral view”, wire-free technology, and long-lasting recording time. It is equipped with 4 high frame rate cameras (3-5 frames/second/camera), located at the side of the capsule. Previous studies, comparing this device with frontal view SBCs, showed comparable operative and diagnostic performance [Friedrich K, et al. J Gastroenterol Hepatol 2013; Pioche M, et al.Endoscopy 2014]. We conducted a multicenter, observational study to assess the performance of CapsoCamÒ SV1 in real life clinical setting. Methods: Between January and November 2014, all consecutive patients undergoing SBC with CapsoCamÒ SV1 in four Italian and one British Institutions were enrolled. All the identified findings were classified according to their bleeding probability and clinical significance, in line with Saurin classification [Saurin JC, et al. Endoscopy 2003], as P0: low probability; P1: intermediate probability; P2: high probability. Patients were defined “positive” whether at least one P2 finding was identified in the video. Results: Fifty-nine patients underwent SBC (30 men; mean age SD: 62 17 years, range: 16-86 years). 48/59 were referred for obscure GI bleeding (OGIB: 11 with overt and 37 with occult GI bleeding) and 11/59 for suspected Crohn’s disease (CD). No technical failure was recorded. 58/59 patients excreted and retrieved the capsule. One capsule was retained due to a neoplastic stricture, no acute obstruction occurred and retrieval was done at time of surgery. The overall diagnostic yield (rate of positive tests) was 42%, whereas it was 40% for OGIB and 55% for suspected CD. The ampulla of Vater was identified in 26 patients (27/59: 46%) and the capsule explored the entire small bowel in 93% of patients. In a per-lesion analysis, overall 217 findings were detected (P0: 27, P1: 93, P2: 97). Most of the lesions were located in the small bowel (186/217: 86%) and 51% of them were P2. Interestingly, 30/217 lesions (14%) were detected in the upper GI tract and ten of them were classified as P2; four patients with overt GI bleeding and one suspected for CD (5/59: 8%) had a positive test for lesions located in the upper GI tract. Conclusions: Our data suggest that, even when used in the everyday clinical practice, CapsoCamÒ SV1 have a detection rate and a safety profile at least equal to other SBC with frontal view.
Mo1589 Role of Second-Generation Colon Capsule Endoscopy for Whole Gut Evaluation Cristiano Spada*, Cesare Hassan, Mariachiara Campanale, Lucio Petruzziello, Guido Costamagna Digestive Endoscopy Unit, Catholic University, Rome, Italy Background: although colon capsule endoscopy (CCE) was developed for evaluation of the colon, it can be used to assess the entire GI tract since it offers excellent images also of the esophagus and the small bowel (SB), with the exception of the stomach that remains poorly evaluated. Usually, after the firsts 3 min of running, CCE slows down the frame rate to 14 images/min. When SB is detected CCE automatically restarts using the Adaptive Frame Rate (AFR) technology. Nevertheless, CCE can be also “activated” to the AFR mode prior to the ingestion allowing the whole gut evaluation at a high frame rate acquisition. Aim of this preliminary, feasibility study was to evaluate the ability of CCE to evaluate esophagus, small bowel and colon if patients take CCE after early, manual activation. Methods: 19 pts (8F, mean age 58 yrs, R 31-78 yrs) were enrolled. All pts underwent second-generation CCE. Pts were invited to follow the standard regimen of preparation for CCE. It consists of the regimen recommended by the ESGE guidelines with the inclusion of Gastrografin in adjunct to sodium phosphate booster. The day of the procedure all
AB476 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
CCE were manually activated to AFR before the ingestion. Pts were asked to swallow CCE following the recommended procedure for ESO capsule. They remained in hospital until CCE transit into the SB was confirmed. They were, then, invited to drink the first booster and leave the hospital. Esophageal, SB and colonic transit times (TT) were evaluated. Esophagoscopy was defined complete when Z line was visualized. Completeness and cleansing level of SB and colon were evaluated. Significant findings were defined as findings that could explain the reason for referral and/or that had any effect on the medical decision making. Results: Indication for CE was: incomplete colonoscopy (nZ7), OGIB (6), colonoscopy refusal (4), iron deficiency anemia (2). A total evaluation of the entire GI tract was possible in 14 out of 19 pts (74%): Z line was not visualized in 4 pts and colonoscopy was incomplete in 1. Overall the Z line was visualized in 15/19 (79%) pts. Mean esophageal capsule TT was 69 sec (R 5-497). 1 (5%) pt had esophagitis. Complete capsule enteroscopy and SB adequate cleansing level was achieved in all pts. Mean SBTT was 106 min (R38-231). Significant SB findings were diagnosed in 3 (16%) pts and included diverticula (1), ulcerations (1) and large bleeding polyp (1). Colon TT was 104 min (R 10-734). CCE was complete and cleansing level was adequate in 18/19 (95%) pts. Significant findings were diagnosed in 6 (31%) pts: R6mm/R3 polyps (5) and caecal angiodysplasia (1). Conclusions: second-generation CCE is feasible for whole GI evaluation and it has a relevant impact on medical decision making. The indications for a pan-endoscopy, however, need to be clarified and the procedure should be validated.
Mo1590 Utility of Flexible Spectral Imaging Colour Enhancement (FICE) for Small Bowel Video Capsule Endoscopy (VCE) Christian S. Jackson2, Christina Chou1, Lauren B. Gerson*1 1 Gastroenterology, California Pacific Medical Center, San Francisco, CA; 2 Gastroenterology, Loma Linda VA Medical Center, Loma Linda, CA Background: Usage of Flexible Spectral Imaging Colour Enhancement (FICE) has been available for video capsule endoscopy (VCE) studies using the Given imaging platform. Some studies have suggested enhanced visualization of small bowel angiodysplasia (GIAD) and other findings with usage of FICE. Methods: We performed a systematic review of the medical literature in order to determine the efficacy of FICE for detection of GIAD and/or ulcerative lesions compared to standard VCE. We searched Pubmed (1990-2014) and Cochrane systematic reviews using search terms including “capsule endoscopy,” “image enhancement,” “ulcerations,” and/or “angiodysplasia.” We included retrospective studies that described improvement in detection rates for GIAD and/or ulcerative lesions using FICE. We included findings reported only with FICE setting 1 (wavelength red 595 nm, green 540 nm, blue 535 nm) since FICE settings 2 and 3 were associated with lower diagnostic yields. We calculated pooled rates with 95% confidence intervals (CI) for detection rates using VCE compared to FICE 1. Odds ratios (OR) with 95% CI were calculated using random effects models when comparing diagnostic yields for VCE and FICE 1 for specific types of findings. For each analysis, FICE was selected as the gold standard for the determination of number of lesions detected. Comprehensive Meta-Analysis (CMA, Version 3, Biostat, Inc.) was used for the statistical analysis. Results: The literature search identified 9 relevant studies. The final analysis included three retrospective studies describing improvement in detection rates with FICE and three studies comparing diagnostic yields using standard viewing on VCE compared to FICE 1. Three studies were excluded for the following reasons: the first study did not detail diagnostic yields, the second paper did not detail total number of lesions found by VCE and/or FICE, and the third study only published sensitivity and specificity values.Characteristics of the included studies are shown in Tables 1 and 2. When improvement in detection rates was the primary outcome measure of the analysis, data from 3 studies demonstrated pooled improvement rates of 87% (95% CI 7295%) for the finding of GIAD, and 60% (95% CI 52-68%) for small bowel ulcerative lesions. Based on the data from 3 studies comparing VCE to FICE 1 for overall detection rates, the OR associated with utilization of FICE was 7.0 (95% CI 2-25, pZ0.003) for detection of GIAD with significant heterogeneity present between studies (I2Z79%, pZ0.0008). For detection of ulcerative lesions, the OR associated with usage of FICE compared to standard VCE was 2.6 (95% CI 1.6-4.1, pZ0.0) without significant heterogeneity (I2Z0%, pZ0.4) Publication bias was not evident for either analysis. Conclusions: Usage of FICE increases detection rates for small bowel GIAD and ulcerative lesions compared to standard VCE. Table 2. Detection Rate for Ulcerations/Erosions with FICE
Author
Year
No. Ulcerations and/or Erosions
Imagawa Sakai Sato
2011 2012 2014
32 82 42
Indication
Ulceration on VCE
Improved Detection rate with FICE 1 (%)
Improved Detection rate with FICE 2 (%)
Various OGIB Various
32 38 28
40 (125%) 62 (75%) 33 (79%)
54 (168%) 60 (73%) 41 (98%)
Improved Detection Rate with FICE 3 51 (159%) 20 (24%) 24 (57%)
VCEZvideo capsule endoscopy; OGIB Z obscure GI bleeding
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high tendency in the SB3 group but there was no significance between the two groups. Conclusion: When we used the RAPID Readar8 and the SB3/DR3 recorder, the interpretation time of the SB2 plus group vs. the SB3 group reduced significantly, but no decrease was observed in the number of the thumbnails and the diagnostic contribution rate. Therefore, we considered that the efficiency of the small intestine capsule endoscopy was achieved by the RAPID Readar8 and the SB3/ DR3 recorder, which realized the possibility of reducing the burden of radiogram interpretation.
Mo1588 The New 360 Panoramic-Viewing Capsule Endoscopy System: Results of the First Multicenter, Observational, Study Gian Eugenio Tontini1, Flaminia Cavallaro1, Roberta Marino4, Mark E. Mcalindon7, Emanuele Rondonotti3, Anastasios Koulaouzidis6, Pasquale Vitagliano5, Luca Pastorelli*2,1, Maurizio Vecchi2,1 1 Gastroenterology & Digestive Endoscopy Unit, IRCCS Policlinico San Donato, San Donato Milanese, Italy; 2Department of Biomedical Sciences for Health, University of Milan, Milano, Italy; 3Gastroenterology Unit, Ospedale Valduce, Como, Italy; 4Gastroenterology and Digestive Endoscopy Unit, AO Lodi, Lodi, Italy; 5Digestive Endoscopy Unit, AO Melegnano, Melegnano, Italy; 6Gastroenterology and Digestive Endoscopy Unit, The Royal Infirmary of Edinburgh, Edinburgh, United Kingdom; 7Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom
Background & Aims: CapsoCamÒ SV1 (CapsoVision Inc, Saratoga, USA) is a new small bowel capsule (SBC) with “panoramic lateral view”, wire-free technology, and long-lasting recording time. It is equipped with 4 high frame rate cameras (3-5 frames/second/camera), located at the side of the capsule. Previous studies, comparing this device with frontal view SBCs, showed comparable operative and diagnostic performance [Friedrich K, et al. J Gastroenterol Hepatol 2013; Pioche M, et al.Endoscopy 2014]. We conducted a multicenter, observational study to assess the performance of CapsoCamÒ SV1 in real life clinical setting. Methods: Between January and November 2014, all consecutive patients undergoing SBC with CapsoCamÒ SV1 in four Italian and one British Institutions were enrolled. All the identified findings were classified according to their bleeding probability and clinical significance, in line with Saurin classification [Saurin JC, et al. Endoscopy 2003], as P0: low probability; P1: intermediate probability; P2: high probability. Patients were defined “positive” whether at least one P2 finding was identified in the video. Results: Fifty-nine patients underwent SBC (30 men; mean age SD: 62 17 years, range: 16-86 years). 48/59 were referred for obscure GI bleeding (OGIB: 11 with overt and 37 with occult GI bleeding) and 11/59 for suspected Crohn’s disease (CD). No technical failure was recorded. 58/59 patients excreted and retrieved the capsule. One capsule was retained due to a neoplastic stricture, no acute obstruction occurred and retrieval was done at time of surgery. The overall diagnostic yield (rate of positive tests) was 42%, whereas it was 40% for OGIB and 55% for suspected CD. The ampulla of Vater was identified in 26 patients (27/59: 46%) and the capsule explored the entire small bowel in 93% of patients. In a per-lesion analysis, overall 217 findings were detected (P0: 27, P1: 93, P2: 97). Most of the lesions were located in the small bowel (186/217: 86%) and 51% of them were P2. Interestingly, 30/217 lesions (14%) were detected in the upper GI tract and ten of them were classified as P2; four patients with overt GI bleeding and one suspected for CD (5/59: 8%) had a positive test for lesions located in the upper GI tract. Conclusions: Our data suggest that, even when used in the everyday clinical practice, CapsoCamÒ SV1 have a detection rate and a safety profile at least equal to other SBC with frontal view.
Mo1589 Role of Second-Generation Colon Capsule Endoscopy for Whole Gut Evaluation Cristiano Spada*, Cesare Hassan, Mariachiara Campanale, Lucio Petruzziello, Guido Costamagna Digestive Endoscopy Unit, Catholic University, Rome, Italy Background: although colon capsule endoscopy (CCE) was developed for evaluation of the colon, it can be used to assess the entire GI tract since it offers excellent images also of the esophagus and the small bowel (SB), with the exception of the stomach that remains poorly evaluated. Usually, after the firsts 3 min of running, CCE slows down the frame rate to 14 images/min. When SB is detected CCE automatically restarts using the Adaptive Frame Rate (AFR) technology. Nevertheless, CCE can be also “activated” to the AFR mode prior to the ingestion allowing the whole gut evaluation at a high frame rate acquisition. Aim of this preliminary, feasibility study was to evaluate the ability of CCE to evaluate esophagus, small bowel and colon if patients take CCE after early, manual activation. Methods: 19 pts (8F, mean age 58 yrs, R 31-78 yrs) were enrolled. All pts underwent second-generation CCE. Pts were invited to follow the standard regimen of preparation for CCE. It consists of the regimen recommended by the ESGE guidelines with the inclusion of Gastrografin in adjunct to sodium phosphate booster. The day of the procedure all
AB476 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
CCE were manually activated to AFR before the ingestion. Pts were asked to swallow CCE following the recommended procedure for ESO capsule. They remained in hospital until CCE transit into the SB was confirmed. They were, then, invited to drink the first booster and leave the hospital. Esophageal, SB and colonic transit times (TT) were evaluated. Esophagoscopy was defined complete when Z line was visualized. Completeness and cleansing level of SB and colon were evaluated. Significant findings were defined as findings that could explain the reason for referral and/or that had any effect on the medical decision making. Results: Indication for CE was: incomplete colonoscopy (nZ7), OGIB (6), colonoscopy refusal (4), iron deficiency anemia (2). A total evaluation of the entire GI tract was possible in 14 out of 19 pts (74%): Z line was not visualized in 4 pts and colonoscopy was incomplete in 1. Overall the Z line was visualized in 15/19 (79%) pts. Mean esophageal capsule TT was 69 sec (R 5-497). 1 (5%) pt had esophagitis. Complete capsule enteroscopy and SB adequate cleansing level was achieved in all pts. Mean SBTT was 106 min (R38-231). Significant SB findings were diagnosed in 3 (16%) pts and included diverticula (1), ulcerations (1) and large bleeding polyp (1). Colon TT was 104 min (R 10-734). CCE was complete and cleansing level was adequate in 18/19 (95%) pts. Significant findings were diagnosed in 6 (31%) pts: R6mm/R3 polyps (5) and caecal angiodysplasia (1). Conclusions: second-generation CCE is feasible for whole GI evaluation and it has a relevant impact on medical decision making. The indications for a pan-endoscopy, however, need to be clarified and the procedure should be validated.
Mo1590 Utility of Flexible Spectral Imaging Colour Enhancement (FICE) for Small Bowel Video Capsule Endoscopy (VCE) Christian S. Jackson2, Christina Chou1, Lauren B. Gerson*1 1 Gastroenterology, California Pacific Medical Center, San Francisco, CA; 2 Gastroenterology, Loma Linda VA Medical Center, Loma Linda, CA Background: Usage of Flexible Spectral Imaging Colour Enhancement (FICE) has been available for video capsule endoscopy (VCE) studies using the Given imaging platform. Some studies have suggested enhanced visualization of small bowel angiodysplasia (GIAD) and other findings with usage of FICE. Methods: We performed a systematic review of the medical literature in order to determine the efficacy of FICE for detection of GIAD and/or ulcerative lesions compared to standard VCE. We searched Pubmed (1990-2014) and Cochrane systematic reviews using search terms including “capsule endoscopy,” “image enhancement,” “ulcerations,” and/or “angiodysplasia.” We included retrospective studies that described improvement in detection rates for GIAD and/or ulcerative lesions using FICE. We included findings reported only with FICE setting 1 (wavelength red 595 nm, green 540 nm, blue 535 nm) since FICE settings 2 and 3 were associated with lower diagnostic yields. We calculated pooled rates with 95% confidence intervals (CI) for detection rates using VCE compared to FICE 1. Odds ratios (OR) with 95% CI were calculated using random effects models when comparing diagnostic yields for VCE and FICE 1 for specific types of findings. For each analysis, FICE was selected as the gold standard for the determination of number of lesions detected. Comprehensive Meta-Analysis (CMA, Version 3, Biostat, Inc.) was used for the statistical analysis. Results: The literature search identified 9 relevant studies. The final analysis included three retrospective studies describing improvement in detection rates with FICE and three studies comparing diagnostic yields using standard viewing on VCE compared to FICE 1. Three studies were excluded for the following reasons: the first study did not detail diagnostic yields, the second paper did not detail total number of lesions found by VCE and/or FICE, and the third study only published sensitivity and specificity values.Characteristics of the included studies are shown in Tables 1 and 2. When improvement in detection rates was the primary outcome measure of the analysis, data from 3 studies demonstrated pooled improvement rates of 87% (95% CI 7295%) for the finding of GIAD, and 60% (95% CI 52-68%) for small bowel ulcerative lesions. Based on the data from 3 studies comparing VCE to FICE 1 for overall detection rates, the OR associated with utilization of FICE was 7.0 (95% CI 2-25, pZ0.003) for detection of GIAD with significant heterogeneity present between studies (I2Z79%, pZ0.0008). For detection of ulcerative lesions, the OR associated with usage of FICE compared to standard VCE was 2.6 (95% CI 1.6-4.1, pZ0.0) without significant heterogeneity (I2Z0%, pZ0.4) Publication bias was not evident for either analysis. Conclusions: Usage of FICE increases detection rates for small bowel GIAD and ulcerative lesions compared to standard VCE. Table 2. Detection Rate for Ulcerations/Erosions with FICE
Author
Year
No. Ulcerations and/or Erosions
Imagawa Sakai Sato
2011 2012 2014
32 82 42
Indication
Ulceration on VCE
Improved Detection rate with FICE 1 (%)
Improved Detection rate with FICE 2 (%)
Various OGIB Various
32 38 28
40 (125%) 62 (75%) 33 (79%)
54 (168%) 60 (73%) 41 (98%)
Improved Detection Rate with FICE 3 51 (159%) 20 (24%) 24 (57%)
VCEZvideo capsule endoscopy; OGIB Z obscure GI bleeding
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