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Sa1085 A Prospective Study of the Efficacy and Safety of Endoscopic Submucosal Dissection Using an Overtube With a Leak-Proof Adapter for Early Gastric Cancer: A Multicenter Study
Abstracts
However, its benefit has never been studied by well-designed trials. Furthermore, great variance exist in the timing, duration, dosage and choice of drug and the optimal regimen is yet to be established. According to our experience of more than 1000 patients, only one dose of second generation cephalosporin was given before POEM. Meanwhile, a minority of patients didn’t receive any antibiotic during treatment because of multiple antibiotics allergy and recovered well. Objective: To evaluate effectiveness of preoperative antibiotic prophylaxis. Methods: This study is a randomized controlled trial. Control group received 2g cefotiam 30 minutes before start of POEM, and study group received no preoperative antibiotics. No patients received therapeutic antibiotics unless indications for antibiotic emerged after POEM like: suspected infection, severe bleeding and so on. The primary outcome measurement was the therapeutic antibiotic use. The secondary outcome was result of blood culture and various markers for infection, including temperature, WBC, CRP and PCT. Results: A total of 106 patients were randomized between Nov, 2012 and May, 2013, 55 to the study group and 51 to the control group. Two patients from the study group withdrew due to unsuccessful POEM. Fifty-three patients were finally included in the study group and 51 patients in the control group. Seven (13.21%) patients in the study group and one (1.96%) patient in the control group received postoperative antibiotics (pZ0.074). The seven patients in the study group received antibiotics because of severe intraoperative bleeding (nZ1), WBC> 20X10^9/L (nZ2), temperature> 39.0 C (nZ2), symptomatic pleural effusion (nZ1) and mucosal tunnel dehiscence (nZ1). One patient in the control group received antibiotics due to aspiration during intubation. No difference was detected in pre or postoperative blood culture, temperature, level of WBC, CRP or PCT between the two groups. Conclusions: Preoperative second-generation cephalosporin seemed to be effective at reducing need of postoperative antibiotics. Even it was no difference for therapeutic antibiotic use after POEM compared with no prophylaxis antibiotic based on the current data. But this clinical trial is based on a small scale and only on our endoscopic center experience. Besides, the difference between one single dose of antibiotic prophylaxis and combined antibiotic use or long time use is unclear.
Sa1085 A Prospective Study of the Efficacy and Safety of Endoscopic Submucosal Dissection Using an Overtube With a Leak-Proof Adapter for Early Gastric Cancer: A Multicenter Study Koichiro Sato*1, Takuya Yamada2, Sayo Ito3, Tomuyuki Kitagawa4, Eiji Mita2, Ichiro Yasuda1, Kiyokazu Nakajima5, Iruru Maetani3 1 Department of Gastroenterology, Mizonokuchi Hospital, Teikyo University School of Medicine, Kanagawa, Japan; 2Department of Gastroenterology, National Hospital Organization, Osaka National Hospital, Osaka, Japan; 3Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan; 4Dokkyo Medical University Koshigaya Hospital, Saitama, Japan; 5Division of Next Generation Endoscopic Intervention (Project ENGINE), Global Center for Medical Engineering and Informatics, Osaka University, Osaka, Japan Background: Endoscopic submucosal dissection (ESD) for early gastric cancer has become accepted as the standard endoscopic treatment. However, in patients with hiatal hernia, endoscopists have difficulty in maintaining optimal visualization during the procedure, as the gas once insufflated into the gastric lumen often escapes proximally. Thus, ESD becomes technically challenging in these patients compared with those without hiatal hernia. Osaka University and Top Corporation (Tokyo, Japan) have developed a novel leak proof adapter (Leak CutterÒ), which is compatible with a standard overtube. This device may prevent luminal collapse during gastric ESD. We assessed the safety and efficacy of our technique using Leak Cutter in patients with severe hiatal hernia. Methods: Between September 2013 and January 2015, we performed ESD on 17 consecutive gastric tumors in 16 patients using the Leak Cutter with an overtube under carbon dioxide insufflation. Severe hiatal hernia was defined as grade A (sac-shaped portion covered with gastric mucosa visible 3 cm above the hiatus) or grade B (gastric mucosa visible circumferentially <3 cm above the hiatus) under the Makuuchi classification. We evaluated 1) en bloc resection rate, 2) curative resection rate, 3) procedural time, 4) rate of luminal collapse, and 5) number of instances of luminal collapse and complications (if any). We then compared these findings with those in control cases without the Leak Cutter with overtube. Results: The median (interquartile range [IQR]) specimen size was 35mm (33-45), and the median (IQR) procedural time was 55min (2476). There were 4 cases with grade A hernia and 12 with grade B hernia, respectively. The rate of en bloc resection was 94% (16/17). The luminal collapse occurred in 23.5% (4/17) of cases, and the median (IQR) number of instances of collapse was 0 (0-0.5). Delayed bleeding occurred in 5.9% (1/17) in our series. No perforation was encountered during ESD. In the control subjects, the rate of en bloc resection was 100% (15/15), and the median (IQR) specimen size was 35mm (32-43). There were no marked differences between the two groups in these parameters. However, there were significant differences in the rate of luminal collapse (66.7% [10/15]; PZ 0.014) and in the median (IQR) number of instances of luminal collapse (2[2-3];PZ0.0006). The median (IQR) procedural time was 77min (59-118) in the control subjects, which tended to be longer than that in the Leak Cutter group (PZ0.0598). Conclusions: ESD for gastric cancer with hiatal hernia was safe with use of Leak Cut-
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ter. The use of this new device may lead to fewer luminal collapse, better visualization, and shorter procedural time. Further accumulation of clinical cases is necessary to conclude its true effectiveness in gastric ESD.
Sa1086 The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation Jung Won Lee*2,1, Joon Young Choi2, Hyuk Yoon2, Gyeongjae Na2, Cheol Min Shin2, Young Soo Park2, Nayoung Kim2, Dong Ho Lee2 1 Department of Internal medicine, Samsung Changwon Hospital, Changwon, Korea (the Republic of); 2Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of) Introduction: 2L polyethylene glycol plus ascorbic acid (PEGA) is known to be as effective as standard 4L polyethylene glycol for bowel preparation. However, the volume of this regimen is still large to ingest. Therefore, we evaluated the potential of 1L PEGA with prepackaged low-residue diet (PLD) for an alternative to 2L PEGA. We report the interim results of this ongoing study. Aims & Methods: The subjects were randomly assigned either to PEGA group or PLD group (n Z 100 for each group). PEGA group received 2L PEGA (a split regimen for morning colonoscopy and a same-day regimen for afternoon colonoscopy). PLD group received PLD on the day preceding colonoscopy and 1L PEGA on the morning of colonoscopy. A questionnaire regarding bowel preparation was administrated on the morning of colonoscopy by telephone. One blinded endoscopist performed colonoscopy and evaluated the degree of bowel preparation using Boston bowel preparation score (BBPS). Achievement of adequacy was defined as having BBPS scores of 2 or 3 for all colon segments. Results: A total of 173 patients completed this study (86 in PEGA group, 87 in PLD group). There were no significant differences in the baseline characteristics such as sex, history of abdominal surgery, body mass index, and indication for colonoscopy between the two groups. The mean age of the patients with PLD group was older than PEGA group (53.6 vs 58.1, p Z 0.02). Total BBPS score (7.51.3 vs 7.91.5, p Z 0.02) and BBPS of right side colon (2.30.6 vs 2.50.7, p Z 0.01) were higher in PLD group than in PEGA group. Furthermore bowel preparation was adequate in 91.9% (79/86) of patients in the PEGA group and 93.1% of the PLD group (81/87) and there is no significant difference (p Z 0.28). There were no differences in the cecal intubation rate (95.3% vs. 88.5%, p Z 0.20), cecal intubation time (mean 291.5 seconds vs. 334.2 seconds, p Z 0.20), observation time (mean 732.0 seconds vs. 809.2 seconds, p Z 0.11), and adenoma detection rate (39.5% vs. 40.2%, p Z 0.93) between PEGA and PLD groups. There was no significant difference between the two groups with respect to compliance (100% for PEGA vs 98.9% for PLD, p Z 1.00). The patients in PLD group expressed more satisfaction (14.0% for PEGA vs 63.2% for PLD, p < 0.01) and willingness to repeat (25.6% for PEGA vs 90.8% for PLD, p < 0.01) the procedure than patients in the PEGA group. In aspect of safety, there were no significant differences for adverse events between the two groups. Conclusions: 1L PEGA with PLD showed comparable efficacy, tolerability and safety for bowel preparation compared to conventional 2L PEGA.
Sa1087 Does the Use of Local Anaesthetic (LA) Spray Combined With IV Sedation for Diagnostic Ogd Affect 8-Day Re-Admission and 30-Day Mortality? James Ansell1, Chris Brown*1, Nafi Dilaver2, Richard Egan1, Charlotte Leaman1, Jeremy Williamson1, Tarig Abdelrahman1, Jeff Turner2 1 Department of Surgery, University Hospital of Wales, Cardiff, United Kingdom; 2University Hospital of Wales, Cardiff, United Kingdom Introduction: Historic evidence suggests that using local anaesthetic (LA) spray with intravenous sedation may increase the risk of morbidity in patients undergoing OGD1. This research was published during a time when large dosages of sedation were commonly given without routine monitoring. Recommended doses of sedation for OGD are now significantly less. The aim was to establish if LA with sedation remains a risk factor for patients undergoing OGD. Methods: A retrospective review of all OGDs performed between October 2014-15 was conducted at 4 Welsh Health Boards. Inpatient OGDs and those performed under GA were excluded. The data was grouped into; LA alone, sedation alone and LA+sedation. Primary outcome measures were; 8-day readmission rate and 30-day mortality. Results: 1715 OGDs were analysed (mean age, 62.9 [SE0.4], 63% Male). 976 (56.9%) patients received LA alone, 263 (15.3%) patients received sedation alone and 476 (27.8%) patients received LA+sedation. The 8-day readmission rate was; 5 (0.3%) LA alone, 4 (0.2%) sedation alone and 8 (0.5%) LA + sedation (pZ0.72). The 30-day mortality rate was; 0 (0%) LA alone, 1 (0.06%) sedation alone and 4 (0.2%) LA + sedation (pZ0.37). The mean sedation dose for the total cohort was 2.1mg (CI 2.0-2.1) vs. 2.3mg (CI 1.8-2.7) for patients with 8-day readmission/ 30-day mortality (pZ<0.001). Discussion: The use of LA spray with sedation does not adversely affect 8-day readmission and 30-day mortality for patients undergoing OGD. Morbidity and mortality
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB185
However, its benefit has never been studied by well-designed trials. Furthermore, great variance exist in the timing, duration, dosage and choice of drug and the optimal regimen is yet to be established. According to our experience of more than 1000 patients, only one dose of second generation cephalosporin was given before POEM. Meanwhile, a minority of patients didn’t receive any antibiotic during treatment because of multiple antibiotics allergy and recovered well. Objective: To evaluate effectiveness of preoperative antibiotic prophylaxis. Methods: This study is a randomized controlled trial. Control group received 2g cefotiam 30 minutes before start of POEM, and study group received no preoperative antibiotics. No patients received therapeutic antibiotics unless indications for antibiotic emerged after POEM like: suspected infection, severe bleeding and so on. The primary outcome measurement was the therapeutic antibiotic use. The secondary outcome was result of blood culture and various markers for infection, including temperature, WBC, CRP and PCT. Results: A total of 106 patients were randomized between Nov, 2012 and May, 2013, 55 to the study group and 51 to the control group. Two patients from the study group withdrew due to unsuccessful POEM. Fifty-three patients were finally included in the study group and 51 patients in the control group. Seven (13.21%) patients in the study group and one (1.96%) patient in the control group received postoperative antibiotics (pZ0.074). The seven patients in the study group received antibiotics because of severe intraoperative bleeding (nZ1), WBC> 20X10^9/L (nZ2), temperature> 39.0 C (nZ2), symptomatic pleural effusion (nZ1) and mucosal tunnel dehiscence (nZ1). One patient in the control group received antibiotics due to aspiration during intubation. No difference was detected in pre or postoperative blood culture, temperature, level of WBC, CRP or PCT between the two groups. Conclusions: Preoperative second-generation cephalosporin seemed to be effective at reducing need of postoperative antibiotics. Even it was no difference for therapeutic antibiotic use after POEM compared with no prophylaxis antibiotic based on the current data. But this clinical trial is based on a small scale and only on our endoscopic center experience. Besides, the difference between one single dose of antibiotic prophylaxis and combined antibiotic use or long time use is unclear.
Sa1085 A Prospective Study of the Efficacy and Safety of Endoscopic Submucosal Dissection Using an Overtube With a Leak-Proof Adapter for Early Gastric Cancer: A Multicenter Study Koichiro Sato*1, Takuya Yamada2, Sayo Ito3, Tomuyuki Kitagawa4, Eiji Mita2, Ichiro Yasuda1, Kiyokazu Nakajima5, Iruru Maetani3 1 Department of Gastroenterology, Mizonokuchi Hospital, Teikyo University School of Medicine, Kanagawa, Japan; 2Department of Gastroenterology, National Hospital Organization, Osaka National Hospital, Osaka, Japan; 3Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan; 4Dokkyo Medical University Koshigaya Hospital, Saitama, Japan; 5Division of Next Generation Endoscopic Intervention (Project ENGINE), Global Center for Medical Engineering and Informatics, Osaka University, Osaka, Japan Background: Endoscopic submucosal dissection (ESD) for early gastric cancer has become accepted as the standard endoscopic treatment. However, in patients with hiatal hernia, endoscopists have difficulty in maintaining optimal visualization during the procedure, as the gas once insufflated into the gastric lumen often escapes proximally. Thus, ESD becomes technically challenging in these patients compared with those without hiatal hernia. Osaka University and Top Corporation (Tokyo, Japan) have developed a novel leak proof adapter (Leak CutterÒ), which is compatible with a standard overtube. This device may prevent luminal collapse during gastric ESD. We assessed the safety and efficacy of our technique using Leak Cutter in patients with severe hiatal hernia. Methods: Between September 2013 and January 2015, we performed ESD on 17 consecutive gastric tumors in 16 patients using the Leak Cutter with an overtube under carbon dioxide insufflation. Severe hiatal hernia was defined as grade A (sac-shaped portion covered with gastric mucosa visible 3 cm above the hiatus) or grade B (gastric mucosa visible circumferentially <3 cm above the hiatus) under the Makuuchi classification. We evaluated 1) en bloc resection rate, 2) curative resection rate, 3) procedural time, 4) rate of luminal collapse, and 5) number of instances of luminal collapse and complications (if any). We then compared these findings with those in control cases without the Leak Cutter with overtube. Results: The median (interquartile range [IQR]) specimen size was 35mm (33-45), and the median (IQR) procedural time was 55min (2476). There were 4 cases with grade A hernia and 12 with grade B hernia, respectively. The rate of en bloc resection was 94% (16/17). The luminal collapse occurred in 23.5% (4/17) of cases, and the median (IQR) number of instances of collapse was 0 (0-0.5). Delayed bleeding occurred in 5.9% (1/17) in our series. No perforation was encountered during ESD. In the control subjects, the rate of en bloc resection was 100% (15/15), and the median (IQR) specimen size was 35mm (32-43). There were no marked differences between the two groups in these parameters. However, there were significant differences in the rate of luminal collapse (66.7% [10/15]; PZ 0.014) and in the median (IQR) number of instances of luminal collapse (2[2-3];PZ0.0006). The median (IQR) procedural time was 77min (59-118) in the control subjects, which tended to be longer than that in the Leak Cutter group (PZ0.0598). Conclusions: ESD for gastric cancer with hiatal hernia was safe with use of Leak Cut-
www.giejournal.org
ter. The use of this new device may lead to fewer luminal collapse, better visualization, and shorter procedural time. Further accumulation of clinical cases is necessary to conclude its true effectiveness in gastric ESD.
Sa1086 The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation Jung Won Lee*2,1, Joon Young Choi2, Hyuk Yoon2, Gyeongjae Na2, Cheol Min Shin2, Young Soo Park2, Nayoung Kim2, Dong Ho Lee2 1 Department of Internal medicine, Samsung Changwon Hospital, Changwon, Korea (the Republic of); 2Department of Internal medicine, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of) Introduction: 2L polyethylene glycol plus ascorbic acid (PEGA) is known to be as effective as standard 4L polyethylene glycol for bowel preparation. However, the volume of this regimen is still large to ingest. Therefore, we evaluated the potential of 1L PEGA with prepackaged low-residue diet (PLD) for an alternative to 2L PEGA. We report the interim results of this ongoing study. Aims & Methods: The subjects were randomly assigned either to PEGA group or PLD group (n Z 100 for each group). PEGA group received 2L PEGA (a split regimen for morning colonoscopy and a same-day regimen for afternoon colonoscopy). PLD group received PLD on the day preceding colonoscopy and 1L PEGA on the morning of colonoscopy. A questionnaire regarding bowel preparation was administrated on the morning of colonoscopy by telephone. One blinded endoscopist performed colonoscopy and evaluated the degree of bowel preparation using Boston bowel preparation score (BBPS). Achievement of adequacy was defined as having BBPS scores of 2 or 3 for all colon segments. Results: A total of 173 patients completed this study (86 in PEGA group, 87 in PLD group). There were no significant differences in the baseline characteristics such as sex, history of abdominal surgery, body mass index, and indication for colonoscopy between the two groups. The mean age of the patients with PLD group was older than PEGA group (53.6 vs 58.1, p Z 0.02). Total BBPS score (7.51.3 vs 7.91.5, p Z 0.02) and BBPS of right side colon (2.30.6 vs 2.50.7, p Z 0.01) were higher in PLD group than in PEGA group. Furthermore bowel preparation was adequate in 91.9% (79/86) of patients in the PEGA group and 93.1% of the PLD group (81/87) and there is no significant difference (p Z 0.28). There were no differences in the cecal intubation rate (95.3% vs. 88.5%, p Z 0.20), cecal intubation time (mean 291.5 seconds vs. 334.2 seconds, p Z 0.20), observation time (mean 732.0 seconds vs. 809.2 seconds, p Z 0.11), and adenoma detection rate (39.5% vs. 40.2%, p Z 0.93) between PEGA and PLD groups. There was no significant difference between the two groups with respect to compliance (100% for PEGA vs 98.9% for PLD, p Z 1.00). The patients in PLD group expressed more satisfaction (14.0% for PEGA vs 63.2% for PLD, p < 0.01) and willingness to repeat (25.6% for PEGA vs 90.8% for PLD, p < 0.01) the procedure than patients in the PEGA group. In aspect of safety, there were no significant differences for adverse events between the two groups. Conclusions: 1L PEGA with PLD showed comparable efficacy, tolerability and safety for bowel preparation compared to conventional 2L PEGA.
Sa1087 Does the Use of Local Anaesthetic (LA) Spray Combined With IV Sedation for Diagnostic Ogd Affect 8-Day Re-Admission and 30-Day Mortality? James Ansell1, Chris Brown*1, Nafi Dilaver2, Richard Egan1, Charlotte Leaman1, Jeremy Williamson1, Tarig Abdelrahman1, Jeff Turner2 1 Department of Surgery, University Hospital of Wales, Cardiff, United Kingdom; 2University Hospital of Wales, Cardiff, United Kingdom Introduction: Historic evidence suggests that using local anaesthetic (LA) spray with intravenous sedation may increase the risk of morbidity in patients undergoing OGD1. This research was published during a time when large dosages of sedation were commonly given without routine monitoring. Recommended doses of sedation for OGD are now significantly less. The aim was to establish if LA with sedation remains a risk factor for patients undergoing OGD. Methods: A retrospective review of all OGDs performed between October 2014-15 was conducted at 4 Welsh Health Boards. Inpatient OGDs and those performed under GA were excluded. The data was grouped into; LA alone, sedation alone and LA+sedation. Primary outcome measures were; 8-day readmission rate and 30-day mortality. Results: 1715 OGDs were analysed (mean age, 62.9 [SE0.4], 63% Male). 976 (56.9%) patients received LA alone, 263 (15.3%) patients received sedation alone and 476 (27.8%) patients received LA+sedation. The 8-day readmission rate was; 5 (0.3%) LA alone, 4 (0.2%) sedation alone and 8 (0.5%) LA + sedation (pZ0.72). The 30-day mortality rate was; 0 (0%) LA alone, 1 (0.06%) sedation alone and 4 (0.2%) LA + sedation (pZ0.37). The mean sedation dose for the total cohort was 2.1mg (CI 2.0-2.1) vs. 2.3mg (CI 1.8-2.7) for patients with 8-day readmission/ 30-day mortality (pZ<0.001). Discussion: The use of LA spray with sedation does not adversely affect 8-day readmission and 30-day mortality for patients undergoing OGD. Morbidity and mortality
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB185