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Mo1974 A Novel Retraction Strip for Endoscopic Submucosal Dissection: Preliminary Results of a Randomized Controlled Trial in a Porcine Model
Abstracts
epidemiologic factors. 2 case were excluded of the statistical analysis due to surveillance of polyposis syndrome, to avoid skewing of results. Conclusions: In expert hands, PDR and DDR exceed 50% with advanced white light and FUSE systems. FUSE was not superior to advanced white light endoscopy for the PDR and DDR. However, with FUSE we can reduce procedure duration without any additional adverse events or increased discomfort. These data further demonstrate the safety and feasibility of the new FUSE system.
Hemostatic powder (Endo-clotÔ) is a simple and effective method to prevent post-ESD bleeding in high-risk patients. Therefore, EndoClotTM would be one of a new promising hemostatic method for prevention of post-ESD bleeding. (Clinical trial registration number: NCT02625792)
Comparative FUSE vs Standar Patients Complete colonoscopy Polyps/patient Polyps detection rate (PDR) Diverticulum detection rate (DDR) Polyps size
FUSE 101 97 (96%) 1,26 2,4 50/101 (49%) 56/101 (55%) 6 4 mm
Standard 96 96 (100%) 1,47 1,9 57/96 (59%) 50/96 (52%) 7 6 mm
P 0,60 PZ0,189 PZ0,198 PZ0,671 PZ0,46
Flow chart of enrolled patients through the study
Figure 1. Panoramic view of the ileocecal valve and the appendix hole
Mo1973 Efficacy of Hemostatic Powder (Endo-Clottm) in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-Risk Bleeding Patients Jun Chul Park*, Kyu Yeon Hahn, Sung Kwan Shin, Sang Kil Lee, Yong Chan Lee Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea (the Republic of)
Mo1974 A Novel Retraction Strip for Endoscopic Submucosal Dissection: Preliminary Results of a Randomized Controlled Trial in a Porcine Model Amit Bhatt*1, Neal Mehta2, Andrew T. Strong3, Ari Garber1, Shengqiang Gao4, Mansour A. Parsi1, Tyler Stevens1, Seiichiro Abe5, Yutaka Saito5, John J. Vargo1 1 Gastroenterology, Cleveland Clinic, Cleveland, OH; 2Internal Medicine, Cleveland Clinic, Cleveland, OH; 3General Surgery, Cleveland Clinic, Cleveland, OH; 4Engineering, Cleveland Clinic, Cleveland, OH; 5 Endoscopy, National Cancer Center, Tokyo, Japan
Objectives: The number of high-risk patients for bleeding after gastric endoscopic submucosal dissection (ESD), such as patients taking antithrombotic agents or having a larger lesion has been increased. However, no studies have been evaluated the impact of hemostatic powder for preventing post-ESD bleeding. The aim of this study was to evaluate the efficacy of hemostatic powder (Endo-clotÔ) in preventing post-ESD bleeding in high-risk patients. Methods: This study was a single center, nonrandomized prospective study with historical control cohort group at Severance Hospital, Yonsei University College of Medicine. High-risk patients of post-ESD bleeding were prospectively enrolled in the study group between December, 2015 and July, 2016, whereas patients in the control group were selected from historical control cohort group in our hospital. Bleeding rate of study group within 4 weeks after ESD was compared with a 1:3 matched historical cohort control group. Highrisk of post-ESD bleeding was defined as patients with taking antithrombotic agents or with larger resection (specimen size 40mm). Subgroup analysis was done according to the high risk factors (Group 1: large resection [ 40mm] without antithrombotic therapy; Group 2: antithrombotic therapy with <40mm resection size; Group 3: large resection [ 40mm] with antithrombotic therapy. Results: A total 44 patients underwent gastric ESD and were treated with hemostatic powder (EndoclotÔ). Among them, three controls per case of 40 patients in the Endo-Clot group were matched according to the location (upper third or mid to lower third), use of antithrombotic agents and the specimen size with a margin of 3mm. Finally, a total 157 patients who were 1:3 matched (40 patients in the Endo-Clot group and 117 patients in the control group) were analyzed. Bleeding rate in the Endo-Clot group was significantly lower compared to the control group (10.0% [4/40] vs. 14.5% [17/117], P Z 0.013). Median elapsed time of bleeding after ESD was significantly different between two groups (12.5 days vs. 1.0 day, P Z 0.014). In the subgroup analysis, the bleeding rate of group 1 showed a significant difference between two groups (3.2% [1/31] vs. 8.9% [8/90], PZ<0.001). Even though the proportion of patients who underwent ESD with continued use of antithrombotic agents was significantly higher in the study group, the patients with large resection ( 40mm) and antithrombotic therapy in the Endo-clot group had a lower bleeding rate compared to the control group (Group 3: 33.3% vs. 44.4%, PZ0.388). Conclusions:
Introduction: Endoscopic submucosal dissection (ESD) is a well-proven minimally invasive treatment for early gastrointestinal cancer, but its longer procedure time and risk of complications limits its practice. A major limitation of ESD is the lack of a “second hand” that can provide traction. Reliable tissue retraction exposes the submucosa and allows for safer and faster dissection. Current retraction methods are not always able to deliver retraction in the correct direction, or can interfere with scope movement. We have developed a retraction strip that provides retraction in the correct direction throughout the entire ESD procedure without interfering with scope movement (Figure 1). To assess the feasibility and efficiency of our prototype retraction strip we compared ESD with and without the retraction strip in a porcine model. Methods: This was a randomized controlled study performed in recently cadaveric pigs (< 6 hours from death). This model has life-like tissue response (without bleeding). Each ESD was randomized to be resected with or without the use of the device. The retraction strip is curled in its natural state, so once attached to a lesion it lifts the mucosa exposing the submucosal layer. It has a wire frame allowing easy hemoclip attachment (figure 1). All ESDs were performed by a single ESD expert. Using an acrobat calibrated wire (Cook Medical, Bloomington, United States) a 3cm x 3cm area of mucosa in the proximal stomach was measured and marked. A circumferential incision was performed with a Dual knife (Olympus KD650U, Tokyo Japan). Then the procedures were randomized to ESD with or without the device. In the device arm, a retraction strip was secured to the surface of the mucosa to be resected with 2 Resolution clips (Boston Scientific, Natick, MA, USA). Submucosal dissection was performed with a Dual knife. After each ESD the endoscopist recorded the ease of dissection using a 100mm VAS scale. Results: In total 12 ESDs (6 with and 6 without retraction device) were performed in 3 recently cadaveric pigs. The results of the study are presented in Table 1. ESDs performed with the retraction device, had shorter submucosal dissection time (p <0.003), faster resection rates (p < 0.0486), and were easier to perform (p< 0.003). As expected there was no significant difference in circumferential incision time as the device was placed after circumferential incision is completed. The mean time to device deployment was 4.22.6 minutes. There was a learning curve to device deployment with the first case taking 8 minutes and the last 3 cases taking 2 minutes or less.
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Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB501
Abstracts
Conclusion: Our study showed the feasibility and benefits of retraction strip assisted ESD. Deployment of the device was successful in all cases and it resulted in shorter and easier submucosal dissection.
Comparison of ESD with and without Retraction device Total
Factor ESD Submucosal Dissection Time (min) ESD Circumferential Incision + Dissection Time (min) Circumferential Incision Time (min) En-Bloc Resection Rate (cm2/min) Ease of ESD Procedure Total Number of Fluid Injections Total Volume of Injectate
(NZ12)
With Retraction Device (NZ6)
Without Retraction Device (NZ6)
8.093.6 16.094.8
5.171.7 13.003.6
11.60.55 19.83.0
pvalue 0.0001 0.008
7.752.4 4.593.3 40.8321.1 3.170.83 13.925.1
7.832.3 6.473.8 25.013.8 2.830.75 12.32.2
7.662.7 2.710.66 56.713.7 3.50.84 15.56.8
0.91 0.0486 0.003 0.178 0.319
had to overcome 3 limitations 1) We eliminated any wires by designing the IMD containing electrodes embedded within the flexmap (wings) that contact the muscle directly. 2) We kept the IMD in place by placing it submucosally and suturing the device within the submucosal tunnel and suturing the submucosal tunnel closed. 3) We eliminate the issue of electrical current going through the mucosa or serosa by placing the contact electrodes directly against the muscle within the submucosal space. This method of submucosal implantation of pacemakers and IMDs was validated in 10 ex-vivo porcine stomachs. Conclusions: A new endoscopic method and technique was developed to implant pacemakers and other IMDs into the submucosal space. In-vivo validation will be performed in a live porcine model to study the durability of the technique.
Statistics presented as Mean SD with t-tests. Ease of dissection lower score represents easier dissection
Figure 1: Retraction Strip Device
Mo1975 Endoscopic Method for Device Implantation Into the Gastrointestinal Tract Anil Vegesna*1, Larry S. Miller1, Mohammad Alshelleh1, Aydin Farajidavar2 1 Medicine(Gastroenterology), Northwell Health, Manhasset, NY; 2 Electrical and Computer Engineering, New York Institute of Technology (NYIT), Old Westbury, NY Background: Pacemakers and other implantable medical devices (IMDs) have been developed to deliver therapy within the gastrointestinal tract. However implantation of these devices requires surgery. Minimally invasive implantation of these IMDs by endoscopy has vast applicability but remains a challenge. Aims: To develop a new method of endoscopically implanting pacemakers and IMDs in the gastrointestinal tract using a modification of endoscopic submucosal dissection (ESD) which is usually used to remove mucosal based neoplasms. Methods: Burn marks were made in the area of interest using Hybrid I-knife attached to an Electrosurgical Generator (ERBE) and water jet, passed through an endoscope. Normal saline containing methylene blue dye was injected into the submucosal space to lift the mucosa from the muscular layer. An incision was made in the mucosa to create an opening. The submucosal tunnel was extended while preserving the overlying mucosa and underlying muscle layers. IMD (Figure 1(a) New mock module and (b) The mock module inside an endoscopic overtube.) was implanted within the submucosal tunnel using one of the two mechanisms: 1) the tip of a gastric overtube was placed in the opening of the tunnel and the device was pushed through and placed in the tunnel, 2) a second opening was created at the distal end of the tunnel and the endoscope was passed through the tunnel and the device was pulled into the tunnel from the distal end using a grasper. After the IMD was placed in the tunnel it was sutured in position to the underlying muscle using an endoscopic suturing device (Overstitch, Apollo). Finally, the openings of the tunnel were sutured, embedding the device in the submucosal space. (Figure 2). Results: Developing this method we
AB502 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S : 2017
Mo1976 Development and Initial Validation of a Fully Synthetic and Reusable Endoscopic Suturing Simulator Matthew J. Skinner*, Hiroyuki Aihara, Pichamol Jirapinyo, Christopher C. Thompson Brigham & Women’s Hospital, Boston, MA Background: There are no available synthetic training models for endoscopic suturing, and no objective or validated methods available to assess the progress of an endoscopists technical competence. Simulation is now limited to ex-vivo tissue models, requiring special animal endoscopes, tissue disposal processes, and frequent ordering of fresh material. Aim: To create a synthetic and reusable endoscopic suturing simulator that provides instruction on unique aspects of the technique, and validate a scoring system which delineates novices from experienced practitioners of endoscopic suturing. Methods: Based on kinematic analysis and
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epidemiologic factors. 2 case were excluded of the statistical analysis due to surveillance of polyposis syndrome, to avoid skewing of results. Conclusions: In expert hands, PDR and DDR exceed 50% with advanced white light and FUSE systems. FUSE was not superior to advanced white light endoscopy for the PDR and DDR. However, with FUSE we can reduce procedure duration without any additional adverse events or increased discomfort. These data further demonstrate the safety and feasibility of the new FUSE system.
Hemostatic powder (Endo-clotÔ) is a simple and effective method to prevent post-ESD bleeding in high-risk patients. Therefore, EndoClotTM would be one of a new promising hemostatic method for prevention of post-ESD bleeding. (Clinical trial registration number: NCT02625792)
Comparative FUSE vs Standar Patients Complete colonoscopy Polyps/patient Polyps detection rate (PDR) Diverticulum detection rate (DDR) Polyps size
FUSE 101 97 (96%) 1,26 2,4 50/101 (49%) 56/101 (55%) 6 4 mm
Standard 96 96 (100%) 1,47 1,9 57/96 (59%) 50/96 (52%) 7 6 mm
P 0,60 PZ0,189 PZ0,198 PZ0,671 PZ0,46
Flow chart of enrolled patients through the study
Figure 1. Panoramic view of the ileocecal valve and the appendix hole
Mo1973 Efficacy of Hemostatic Powder (Endo-Clottm) in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-Risk Bleeding Patients Jun Chul Park*, Kyu Yeon Hahn, Sung Kwan Shin, Sang Kil Lee, Yong Chan Lee Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea (the Republic of)
Mo1974 A Novel Retraction Strip for Endoscopic Submucosal Dissection: Preliminary Results of a Randomized Controlled Trial in a Porcine Model Amit Bhatt*1, Neal Mehta2, Andrew T. Strong3, Ari Garber1, Shengqiang Gao4, Mansour A. Parsi1, Tyler Stevens1, Seiichiro Abe5, Yutaka Saito5, John J. Vargo1 1 Gastroenterology, Cleveland Clinic, Cleveland, OH; 2Internal Medicine, Cleveland Clinic, Cleveland, OH; 3General Surgery, Cleveland Clinic, Cleveland, OH; 4Engineering, Cleveland Clinic, Cleveland, OH; 5 Endoscopy, National Cancer Center, Tokyo, Japan
Objectives: The number of high-risk patients for bleeding after gastric endoscopic submucosal dissection (ESD), such as patients taking antithrombotic agents or having a larger lesion has been increased. However, no studies have been evaluated the impact of hemostatic powder for preventing post-ESD bleeding. The aim of this study was to evaluate the efficacy of hemostatic powder (Endo-clotÔ) in preventing post-ESD bleeding in high-risk patients. Methods: This study was a single center, nonrandomized prospective study with historical control cohort group at Severance Hospital, Yonsei University College of Medicine. High-risk patients of post-ESD bleeding were prospectively enrolled in the study group between December, 2015 and July, 2016, whereas patients in the control group were selected from historical control cohort group in our hospital. Bleeding rate of study group within 4 weeks after ESD was compared with a 1:3 matched historical cohort control group. Highrisk of post-ESD bleeding was defined as patients with taking antithrombotic agents or with larger resection (specimen size 40mm). Subgroup analysis was done according to the high risk factors (Group 1: large resection [ 40mm] without antithrombotic therapy; Group 2: antithrombotic therapy with <40mm resection size; Group 3: large resection [ 40mm] with antithrombotic therapy. Results: A total 44 patients underwent gastric ESD and were treated with hemostatic powder (EndoclotÔ). Among them, three controls per case of 40 patients in the Endo-Clot group were matched according to the location (upper third or mid to lower third), use of antithrombotic agents and the specimen size with a margin of 3mm. Finally, a total 157 patients who were 1:3 matched (40 patients in the Endo-Clot group and 117 patients in the control group) were analyzed. Bleeding rate in the Endo-Clot group was significantly lower compared to the control group (10.0% [4/40] vs. 14.5% [17/117], P Z 0.013). Median elapsed time of bleeding after ESD was significantly different between two groups (12.5 days vs. 1.0 day, P Z 0.014). In the subgroup analysis, the bleeding rate of group 1 showed a significant difference between two groups (3.2% [1/31] vs. 8.9% [8/90], PZ<0.001). Even though the proportion of patients who underwent ESD with continued use of antithrombotic agents was significantly higher in the study group, the patients with large resection ( 40mm) and antithrombotic therapy in the Endo-clot group had a lower bleeding rate compared to the control group (Group 3: 33.3% vs. 44.4%, PZ0.388). Conclusions:
Introduction: Endoscopic submucosal dissection (ESD) is a well-proven minimally invasive treatment for early gastrointestinal cancer, but its longer procedure time and risk of complications limits its practice. A major limitation of ESD is the lack of a “second hand” that can provide traction. Reliable tissue retraction exposes the submucosa and allows for safer and faster dissection. Current retraction methods are not always able to deliver retraction in the correct direction, or can interfere with scope movement. We have developed a retraction strip that provides retraction in the correct direction throughout the entire ESD procedure without interfering with scope movement (Figure 1). To assess the feasibility and efficiency of our prototype retraction strip we compared ESD with and without the retraction strip in a porcine model. Methods: This was a randomized controlled study performed in recently cadaveric pigs (< 6 hours from death). This model has life-like tissue response (without bleeding). Each ESD was randomized to be resected with or without the use of the device. The retraction strip is curled in its natural state, so once attached to a lesion it lifts the mucosa exposing the submucosal layer. It has a wire frame allowing easy hemoclip attachment (figure 1). All ESDs were performed by a single ESD expert. Using an acrobat calibrated wire (Cook Medical, Bloomington, United States) a 3cm x 3cm area of mucosa in the proximal stomach was measured and marked. A circumferential incision was performed with a Dual knife (Olympus KD650U, Tokyo Japan). Then the procedures were randomized to ESD with or without the device. In the device arm, a retraction strip was secured to the surface of the mucosa to be resected with 2 Resolution clips (Boston Scientific, Natick, MA, USA). Submucosal dissection was performed with a Dual knife. After each ESD the endoscopist recorded the ease of dissection using a 100mm VAS scale. Results: In total 12 ESDs (6 with and 6 without retraction device) were performed in 3 recently cadaveric pigs. The results of the study are presented in Table 1. ESDs performed with the retraction device, had shorter submucosal dissection time (p <0.003), faster resection rates (p < 0.0486), and were easier to perform (p< 0.003). As expected there was no significant difference in circumferential incision time as the device was placed after circumferential incision is completed. The mean time to device deployment was 4.22.6 minutes. There was a learning curve to device deployment with the first case taking 8 minutes and the last 3 cases taking 2 minutes or less.
www.giejournal.org
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB501
Abstracts
Conclusion: Our study showed the feasibility and benefits of retraction strip assisted ESD. Deployment of the device was successful in all cases and it resulted in shorter and easier submucosal dissection.
Comparison of ESD with and without Retraction device Total
Factor ESD Submucosal Dissection Time (min) ESD Circumferential Incision + Dissection Time (min) Circumferential Incision Time (min) En-Bloc Resection Rate (cm2/min) Ease of ESD Procedure Total Number of Fluid Injections Total Volume of Injectate
(NZ12)
With Retraction Device (NZ6)
Without Retraction Device (NZ6)
8.093.6 16.094.8
5.171.7 13.003.6
11.60.55 19.83.0
pvalue 0.0001 0.008
7.752.4 4.593.3 40.8321.1 3.170.83 13.925.1
7.832.3 6.473.8 25.013.8 2.830.75 12.32.2
7.662.7 2.710.66 56.713.7 3.50.84 15.56.8
0.91 0.0486 0.003 0.178 0.319
had to overcome 3 limitations 1) We eliminated any wires by designing the IMD containing electrodes embedded within the flexmap (wings) that contact the muscle directly. 2) We kept the IMD in place by placing it submucosally and suturing the device within the submucosal tunnel and suturing the submucosal tunnel closed. 3) We eliminate the issue of electrical current going through the mucosa or serosa by placing the contact electrodes directly against the muscle within the submucosal space. This method of submucosal implantation of pacemakers and IMDs was validated in 10 ex-vivo porcine stomachs. Conclusions: A new endoscopic method and technique was developed to implant pacemakers and other IMDs into the submucosal space. In-vivo validation will be performed in a live porcine model to study the durability of the technique.
Statistics presented as Mean SD with t-tests. Ease of dissection lower score represents easier dissection
Figure 1: Retraction Strip Device
Mo1975 Endoscopic Method for Device Implantation Into the Gastrointestinal Tract Anil Vegesna*1, Larry S. Miller1, Mohammad Alshelleh1, Aydin Farajidavar2 1 Medicine(Gastroenterology), Northwell Health, Manhasset, NY; 2 Electrical and Computer Engineering, New York Institute of Technology (NYIT), Old Westbury, NY Background: Pacemakers and other implantable medical devices (IMDs) have been developed to deliver therapy within the gastrointestinal tract. However implantation of these devices requires surgery. Minimally invasive implantation of these IMDs by endoscopy has vast applicability but remains a challenge. Aims: To develop a new method of endoscopically implanting pacemakers and IMDs in the gastrointestinal tract using a modification of endoscopic submucosal dissection (ESD) which is usually used to remove mucosal based neoplasms. Methods: Burn marks were made in the area of interest using Hybrid I-knife attached to an Electrosurgical Generator (ERBE) and water jet, passed through an endoscope. Normal saline containing methylene blue dye was injected into the submucosal space to lift the mucosa from the muscular layer. An incision was made in the mucosa to create an opening. The submucosal tunnel was extended while preserving the overlying mucosa and underlying muscle layers. IMD (Figure 1(a) New mock module and (b) The mock module inside an endoscopic overtube.) was implanted within the submucosal tunnel using one of the two mechanisms: 1) the tip of a gastric overtube was placed in the opening of the tunnel and the device was pushed through and placed in the tunnel, 2) a second opening was created at the distal end of the tunnel and the endoscope was passed through the tunnel and the device was pulled into the tunnel from the distal end using a grasper. After the IMD was placed in the tunnel it was sutured in position to the underlying muscle using an endoscopic suturing device (Overstitch, Apollo). Finally, the openings of the tunnel were sutured, embedding the device in the submucosal space. (Figure 2). Results: Developing this method we
AB502 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S : 2017
Mo1976 Development and Initial Validation of a Fully Synthetic and Reusable Endoscopic Suturing Simulator Matthew J. Skinner*, Hiroyuki Aihara, Pichamol Jirapinyo, Christopher C. Thompson Brigham & Women’s Hospital, Boston, MA Background: There are no available synthetic training models for endoscopic suturing, and no objective or validated methods available to assess the progress of an endoscopists technical competence. Simulation is now limited to ex-vivo tissue models, requiring special animal endoscopes, tissue disposal processes, and frequent ordering of fresh material. Aim: To create a synthetic and reusable endoscopic suturing simulator that provides instruction on unique aspects of the technique, and validate a scoring system which delineates novices from experienced practitioners of endoscopic suturing. Methods: Based on kinematic analysis and
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