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605 Carbon Dioxide Versus Air Insufflation According to Sedation Protocol During Therapeutic ERCP: a Prospective, Randomised, Double-Blind Study
Abstracts Table 1. Distribution of patients and nVLE scores for epithelial
maturation and glandular atypia. Dysplasia score is the sum of maturation plus atypia. P values are in comparison to NDBE Histopath Dx HGD LGD IND NDBE Normal Total
Number Patients 9 10 5 27 16 67
Surface maturation mean score
Glandular atypia score
Dysplasia score
pvalue
1.70 1.73 1.83 1.14
1.52 1.37 1.17 1.35
3.22 3.10 3.00 2.49
0.00041 0.00303 0.03024
604 Endocytoscopy Is Useful for Differential Diagnosis of Superficial Gastric Cancer Ryusuke Kimura*, Mitsuru Kaise, Toshiro Iizuka, Daisuke Kikuchi, Kosuke Nomura, Yasutaka Kuribayashi Toranomon Hospital, Tokyo, Japan Background and aim: Endocytoscopy (ECS) enables in vivo microscopic imaging, thereby allowing the analysis of mucosal structures at the cellular level. We previously reported that high grade ECS atypia showed a high diagnostic accuracy for gastric cancer. The aim of this prospective study was to verify diagnostic accuracy and concordance of defined ECS atypia among trainee and expert endoscopists blinded to clinical information. Method: 121 patients who underwent magnifying endoscopic work-up before or after gastric ESD were evaluated by ECS (GIF-Y0002, Olympus) with a double staining of crystal violet and methylene blue. We extracted 100 lesions (44 early cancers including high grade adenoma, 10 low grade adenomas, 46 non-neoplastic lesions) of which good ECS images were obtained. An ECS image catalog was constructed, in which several representative still images were selected in each lesion by an investigator blinded to pathological results. Four endoscopists (2 trainees and 2 experts) independently reviewed the catalog images and evaluated whether each tested lesion had ECS atypia or not. ECS atypia of gland structure and nucleus was defined by the presence of following morphological abnormalities; absence or narrowing of glandular lumens, glandular fusion, glandular disappearance and nuclear abnormalities (heterogeneous shape or swelling or disarrangement). ECS atypia was graded as none, low and high. Before the evaluation, study participants received a lecture on the definition of ECS atypia and performed 5 cases of ECS diagnosis using a training set of ECS catalogue. Results: 78%, 18% and 4% of cancers, adenoma and non-neoplasia were as having high grade ECS atypia, respectively. Similarly, 20%, 64% and 49% of cancer, adenoma and nonneoplastic lesions were evaluated as having low grade ECS atypia, respectively. Using high grade ECS atypia as a criterion of cancer diagnosis, sensitivity, specificity, PPV and NPV of ECS diagnosis for gastric cancer were 78%, 94%, 91% and 84%, respectively. The concordance rate on high grade ECS atypia was good among 4 endoscopists at 0.68 of kappa value. No significant difference in diagnostic accuracy and concordance was observed between trainee and expert endoscopists. Conclusion: Using the defined high grade atypia as a diagnostic criterion of cancer, ECS exerts satisfying accuracy and concordance in the diagnosis of early gastric cancer, regardless of endoscopic expertise.
605 Carbon Dioxide Versus Air Insufflation According to Sedation Protocol During Therapeutic ERCP: a Prospective, Randomised, Double-Blind Study Su Jin Lee1, Tae Hoon Lee*1, Sang-Heum Park1, Young Sin Cho1, Yunho Jung1, Hyun Jong Choi2, Sang-Woo Cha3, IL-Kwun Chung1, Jong Ho Moon2, Young Deok Cho3, Sun-Joo Kim1 1 Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea; 2Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea; 3Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea Background and study aims: Prolonged or complex ERCP tends to require considerable air insufflation resulting in abdominal pain or distension. To date the advantages of CO2 insufflation during therapeutic ERCP have been uncertain. Moreover, no study has investigated the efficacy of CO2 insufflation during ERCP according to the different sedation protocol used. We aimed to investigate the primary efficacy of carbon dioxide (CO2) compared with air insufflation according to different sedation protocols, such as balanced propofol sedation (BPS) and propofol monosedation (PS) in therapeutic ERCP. Patients and methods: In this prospective randomised double-blind study, patients who required therapeutic ERCP were randomised to four groups: air insufflation with BPS (nZ51), air with PS (nZ57), CO2 with BPS
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(nZ56), and CO2 with PS (nZ56). The target level of sedation was moderate sedation based on the ASA criteria, and a modified assessment of alertness/sedation (MOAA/S) score of 3 in both groups. The primary objective was to compare patients’ satisfaction in terms of post-ERCP abdominal pain, distension, and nausea, according to sedation protocols, as recorded on a 10-point VAS. The research nurse assessed the score just after recovery, 3 h and 24 h later. Gas volume score by 4-point ordinal scale was measured at 2 h and 12 h later. Secondary outcomes included sedation efficacy, endoscopic procedure outcomes, and procedure-related complications. Results: Regardless of the time interval, the mean VAS score of abdominal pain and distension was reduced in the CO2 insufflation group. The mean VAS score for abdominal pain and distension was lowest in the CO2 with PS group (after recovery) and the CO2 with BPS group (after recovery, 3 and 24 h later), respectively (p!0.01). In sedation quality, the mean VAS score of patients’ overall satisfaction with sedation was higher in the CO2 insufflation than the air group, particularly in the CO2 with BPS group (CO2 with BPS vs. air with PS; 9.64 vs. 8.60, pZ0.01). Two and twelve hours post-ERCP, gas volume scores were significantly lower in the CO2 with BPS (p!0.01). The frequency of hypoxia showed an increasing tendency in the air insufflation group (8 vs. 2, pZ0.07). There were no significant differences in complications among subgroups. Conclusions: CO2 insufflation reduced early post-ERCP abdominal pain and distension compared with air insufflation. In the subgroup analysis according to sedation protocols, the mean VAS score of patients’ overall satisfaction with sedation was higher in the CO2 with BPS.
606 Metal Stent Placement Is Cost-Effective for Palliation of Malignant Common Bile Duct Obstruction: a Randomized Controlled Trial Daisy Walter*1, Petra G. Van Boeckel1, Marcel Groenen2, Bas L. Weusten3, Ben J. Witteman4, Gie Tan5, Menno a. Brink6, Jan Nicolai7, Adriaan C. Tan8, Joyce Alderliesten9, Niels G. Venneman10, Wim Laleman11, Jeroen M. Jansen12, Alexander Bodelier13, Frank Wolters14, Laurens Van Der Waaij15, Ronald Breumelhof16, Frans T. Peters17, Robert C. H. Scheffer18, Max Leenders1, Meike M. Hirdes1, Frank P. Vleggaar1, Peter D. Siersema1 1 Gastroenterology and Hepatology, UMC Utrecht, Utrecht, Netherlands; 2 Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, Netherlands; 3Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, Netherlands; 4Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, Netherlands; 5Gastroenterology and Hepatology, Ziekenhuisgroep Twente Hospital, Hengelo, Netherlands; 6 Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, Netherlands; 7Gastroenterology and Hepatology, Haga Hospital, Den Haag, Netherlands; 8Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, Netherlands; 9 Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, Netherlands; 10Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, Netherlands; 11Department of Liver and Biliopancreatic disorders, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium; 12Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands; 13Gastroenterology and Hepatology, Amphia Hospital, Breda, Netherlands; 14 Gastroenterology and Hepatology, VieCuri Hospital, Venlo, Netherlands; 15Gastroenterology and Hepatology, Martini Hospital, Groningen, Netherlands; 16Gastroenterology and Hepatology, Diakonessen Hospital, Utrecht, Netherlands; 17Gastroenterology and Hepatology, UMCG, Groningen, Netherlands; 18Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, Netherlands Endoscopic stent placement is the procedure of choice for palliation of common bile duct (CBD) obstruction. Although self-expandable metals stents (SEMS) are associated with a longer stent patency compared to plastic stents, they are far more expensive. Until now, no detailed cost analysis comparing plastic and metal stent placement has been performed. Aim: To perform a full cost comparison of plastic stent, partially covered SEMS (pcSEMS) and uncovered SEMS (uSEMS) placement for the palliation of CBD obstruction. Methods: Randomized, multicenter trial in 18 hospitals. In total, 219 patients were randomized to a plastic stent (nZ73), uSEMS (nZ75) or pcSEMS (nZ71) with stratification for primary stent placement or stent placement after a first recurrent obstruction. Cost comparison included initial costs and costs during follow-up. Data on health care use were obtained at 2 weeks and monthly thereafter until death or one year follow-up. Non-parametric bootstrapping was used to derive a p-value for the difference in cost distribution. Results: Baseline characteristics were similar between the three groups. Recurrent biliary obstruction occurred in 31 patients (43%) in the plastic stent group, in 11 patients (15%) in the uSEMS group and in 11 patients (16%) in the pcSEMS group. Mean number of reinterventions per stent group was 0.66, 0.25 and 0.24 respectively (p!0.005). Mean stent patency time was 172 days for plastic stents, 288 days for uSEMS and 299 days for pcSEMS (p!0.005). No difference was found in 3-month (pZ0.77) and overall survival between the groups (pZ0.28). Costs for the initial stent placement were significantly lower for plastic stents vs. SEMS (€1,042 vs. €1,973; pZ0.001). However,
Volume 79, No. 5S : 2014 GASTROINTESTINAL ENDOSCOPY AB157
maturation and glandular atypia. Dysplasia score is the sum of maturation plus atypia. P values are in comparison to NDBE Histopath Dx HGD LGD IND NDBE Normal Total
Number Patients 9 10 5 27 16 67
Surface maturation mean score
Glandular atypia score
Dysplasia score
pvalue
1.70 1.73 1.83 1.14
1.52 1.37 1.17 1.35
3.22 3.10 3.00 2.49
0.00041 0.00303 0.03024
604 Endocytoscopy Is Useful for Differential Diagnosis of Superficial Gastric Cancer Ryusuke Kimura*, Mitsuru Kaise, Toshiro Iizuka, Daisuke Kikuchi, Kosuke Nomura, Yasutaka Kuribayashi Toranomon Hospital, Tokyo, Japan Background and aim: Endocytoscopy (ECS) enables in vivo microscopic imaging, thereby allowing the analysis of mucosal structures at the cellular level. We previously reported that high grade ECS atypia showed a high diagnostic accuracy for gastric cancer. The aim of this prospective study was to verify diagnostic accuracy and concordance of defined ECS atypia among trainee and expert endoscopists blinded to clinical information. Method: 121 patients who underwent magnifying endoscopic work-up before or after gastric ESD were evaluated by ECS (GIF-Y0002, Olympus) with a double staining of crystal violet and methylene blue. We extracted 100 lesions (44 early cancers including high grade adenoma, 10 low grade adenomas, 46 non-neoplastic lesions) of which good ECS images were obtained. An ECS image catalog was constructed, in which several representative still images were selected in each lesion by an investigator blinded to pathological results. Four endoscopists (2 trainees and 2 experts) independently reviewed the catalog images and evaluated whether each tested lesion had ECS atypia or not. ECS atypia of gland structure and nucleus was defined by the presence of following morphological abnormalities; absence or narrowing of glandular lumens, glandular fusion, glandular disappearance and nuclear abnormalities (heterogeneous shape or swelling or disarrangement). ECS atypia was graded as none, low and high. Before the evaluation, study participants received a lecture on the definition of ECS atypia and performed 5 cases of ECS diagnosis using a training set of ECS catalogue. Results: 78%, 18% and 4% of cancers, adenoma and non-neoplasia were as having high grade ECS atypia, respectively. Similarly, 20%, 64% and 49% of cancer, adenoma and nonneoplastic lesions were evaluated as having low grade ECS atypia, respectively. Using high grade ECS atypia as a criterion of cancer diagnosis, sensitivity, specificity, PPV and NPV of ECS diagnosis for gastric cancer were 78%, 94%, 91% and 84%, respectively. The concordance rate on high grade ECS atypia was good among 4 endoscopists at 0.68 of kappa value. No significant difference in diagnostic accuracy and concordance was observed between trainee and expert endoscopists. Conclusion: Using the defined high grade atypia as a diagnostic criterion of cancer, ECS exerts satisfying accuracy and concordance in the diagnosis of early gastric cancer, regardless of endoscopic expertise.
605 Carbon Dioxide Versus Air Insufflation According to Sedation Protocol During Therapeutic ERCP: a Prospective, Randomised, Double-Blind Study Su Jin Lee1, Tae Hoon Lee*1, Sang-Heum Park1, Young Sin Cho1, Yunho Jung1, Hyun Jong Choi2, Sang-Woo Cha3, IL-Kwun Chung1, Jong Ho Moon2, Young Deok Cho3, Sun-Joo Kim1 1 Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea; 2Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea; 3Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea Background and study aims: Prolonged or complex ERCP tends to require considerable air insufflation resulting in abdominal pain or distension. To date the advantages of CO2 insufflation during therapeutic ERCP have been uncertain. Moreover, no study has investigated the efficacy of CO2 insufflation during ERCP according to the different sedation protocol used. We aimed to investigate the primary efficacy of carbon dioxide (CO2) compared with air insufflation according to different sedation protocols, such as balanced propofol sedation (BPS) and propofol monosedation (PS) in therapeutic ERCP. Patients and methods: In this prospective randomised double-blind study, patients who required therapeutic ERCP were randomised to four groups: air insufflation with BPS (nZ51), air with PS (nZ57), CO2 with BPS
www.giejournal.org
(nZ56), and CO2 with PS (nZ56). The target level of sedation was moderate sedation based on the ASA criteria, and a modified assessment of alertness/sedation (MOAA/S) score of 3 in both groups. The primary objective was to compare patients’ satisfaction in terms of post-ERCP abdominal pain, distension, and nausea, according to sedation protocols, as recorded on a 10-point VAS. The research nurse assessed the score just after recovery, 3 h and 24 h later. Gas volume score by 4-point ordinal scale was measured at 2 h and 12 h later. Secondary outcomes included sedation efficacy, endoscopic procedure outcomes, and procedure-related complications. Results: Regardless of the time interval, the mean VAS score of abdominal pain and distension was reduced in the CO2 insufflation group. The mean VAS score for abdominal pain and distension was lowest in the CO2 with PS group (after recovery) and the CO2 with BPS group (after recovery, 3 and 24 h later), respectively (p!0.01). In sedation quality, the mean VAS score of patients’ overall satisfaction with sedation was higher in the CO2 insufflation than the air group, particularly in the CO2 with BPS group (CO2 with BPS vs. air with PS; 9.64 vs. 8.60, pZ0.01). Two and twelve hours post-ERCP, gas volume scores were significantly lower in the CO2 with BPS (p!0.01). The frequency of hypoxia showed an increasing tendency in the air insufflation group (8 vs. 2, pZ0.07). There were no significant differences in complications among subgroups. Conclusions: CO2 insufflation reduced early post-ERCP abdominal pain and distension compared with air insufflation. In the subgroup analysis according to sedation protocols, the mean VAS score of patients’ overall satisfaction with sedation was higher in the CO2 with BPS.
606 Metal Stent Placement Is Cost-Effective for Palliation of Malignant Common Bile Duct Obstruction: a Randomized Controlled Trial Daisy Walter*1, Petra G. Van Boeckel1, Marcel Groenen2, Bas L. Weusten3, Ben J. Witteman4, Gie Tan5, Menno a. Brink6, Jan Nicolai7, Adriaan C. Tan8, Joyce Alderliesten9, Niels G. Venneman10, Wim Laleman11, Jeroen M. Jansen12, Alexander Bodelier13, Frank Wolters14, Laurens Van Der Waaij15, Ronald Breumelhof16, Frans T. Peters17, Robert C. H. Scheffer18, Max Leenders1, Meike M. Hirdes1, Frank P. Vleggaar1, Peter D. Siersema1 1 Gastroenterology and Hepatology, UMC Utrecht, Utrecht, Netherlands; 2 Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, Netherlands; 3Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, Netherlands; 4Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, Netherlands; 5Gastroenterology and Hepatology, Ziekenhuisgroep Twente Hospital, Hengelo, Netherlands; 6 Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, Netherlands; 7Gastroenterology and Hepatology, Haga Hospital, Den Haag, Netherlands; 8Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, Netherlands; 9 Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, Netherlands; 10Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, Netherlands; 11Department of Liver and Biliopancreatic disorders, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium; 12Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands; 13Gastroenterology and Hepatology, Amphia Hospital, Breda, Netherlands; 14 Gastroenterology and Hepatology, VieCuri Hospital, Venlo, Netherlands; 15Gastroenterology and Hepatology, Martini Hospital, Groningen, Netherlands; 16Gastroenterology and Hepatology, Diakonessen Hospital, Utrecht, Netherlands; 17Gastroenterology and Hepatology, UMCG, Groningen, Netherlands; 18Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, Netherlands Endoscopic stent placement is the procedure of choice for palliation of common bile duct (CBD) obstruction. Although self-expandable metals stents (SEMS) are associated with a longer stent patency compared to plastic stents, they are far more expensive. Until now, no detailed cost analysis comparing plastic and metal stent placement has been performed. Aim: To perform a full cost comparison of plastic stent, partially covered SEMS (pcSEMS) and uncovered SEMS (uSEMS) placement for the palliation of CBD obstruction. Methods: Randomized, multicenter trial in 18 hospitals. In total, 219 patients were randomized to a plastic stent (nZ73), uSEMS (nZ75) or pcSEMS (nZ71) with stratification for primary stent placement or stent placement after a first recurrent obstruction. Cost comparison included initial costs and costs during follow-up. Data on health care use were obtained at 2 weeks and monthly thereafter until death or one year follow-up. Non-parametric bootstrapping was used to derive a p-value for the difference in cost distribution. Results: Baseline characteristics were similar between the three groups. Recurrent biliary obstruction occurred in 31 patients (43%) in the plastic stent group, in 11 patients (15%) in the uSEMS group and in 11 patients (16%) in the pcSEMS group. Mean number of reinterventions per stent group was 0.66, 0.25 and 0.24 respectively (p!0.005). Mean stent patency time was 172 days for plastic stents, 288 days for uSEMS and 299 days for pcSEMS (p!0.005). No difference was found in 3-month (pZ0.77) and overall survival between the groups (pZ0.28). Costs for the initial stent placement were significantly lower for plastic stents vs. SEMS (€1,042 vs. €1,973; pZ0.001). However,
Volume 79, No. 5S : 2014 GASTROINTESTINAL ENDOSCOPY AB157