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A Pilot Trial Study to Assess Safety and Efficacy of Carbon Dioxide Insufflation During Colorectal Endoscopic Submucosal Dissection
Abstracts
T1456 A Novel Method for Determining the Inner Diameter of the Esophageal Body Using a Non-Compliant Balloon Catheter and Pressure/Volume Monitoring and Inflation System Michael B. Kimmey, Robert A. Ganz, Ronald E. Pruitt, Alvaro Reymunde, Virender K. Sharma, David E. Fleischer Background: Esophageal physiological testing includes manometry, 24-hr pH, esophagram, and impedance testing. More recently, it is possible to measure the inner diameter (ID) of the esophageal body (EB) using a non-compliant balloon with a pressure/volume monitoring/inflation system. Methods: This technology was developed as an adjunct to balloon-based ablation of Barrett’s esophagus (BE) ˆRRX Medical, Sunnyvale, CA). Prior to using the HALO360 Ablation System (BA ablation, ID measurement of the EB is required to: 1) select an ablation balloon size that fits the targeted EB, to ensure electrode contact and mitigate against overstretch, and 2) set ablation energy density (J/cm2) based on the EB ID. The sizing catheter has a non-compliant balloon with outer diameter (OD) 33.7 mm and length 4 cm. Calibration is first performed to record the balloon volume at 4 psi (HALO360 generator). The calibrated (deflated) balloon is passed over a wire, positioned in the EB (5-cm proximal to the top of the BE in cases of ablation), autoinflated to 4 psi, held at steady state for w3 seconds, then auto-deflated. The system displays ID (mm), based on pressure/volume at steady state. Prior to human use, a bench model using 24 cylinders of varying ID (22-33.5 mm) were measured with the system and results of measured vs. actual ID were compared. Thereafter, the system was evaluated in patients undergoing ablation of BE, comparing measured ID, selected ablation balloon ID, and ablation effect. Results: In the cylinder testing, 72 measurements were obtained. The median difference between measured and actual ID was -0.3 mm (IQR -0.5 to 0.0) or -1.2% (IQR -1.7 to 0.0). Thereafter, 238 measurements were made in 34 patients who were undergoing ablation. In the first 20 patients, balloon migration occurred near the gastroesophageal junction (GEJ), confounding measurements. In the final 14 patients, starting higher in the EB resulting in highly reproducible EB ID estimates (median EB ID 25.9 mm, range 21.7-32.6). In 14/14 (100%) cases, an accurate estimate of targeted EB ID was achieved, based on subsequent electrode size and effect. Conclusion: This is the first report of a novel method for measuring the ID in the EB. The results are accurate (within 0.3 mm) and reproducible, and the device is now implemented as an adjunct to ablation of BE (HALO360 Ablation System). Other potential applications may include characterization of non-cardiac CP, quantifying success of stricture dilation, and assessing complications of gastric bypass, fundoplication, and surgical anastomoses.
T1457 Variable Stiffness Therapeutic Duodenoscope (VSTD): Is It Useful? Michael K. Sanders, Douglas a. Howell, Burr J. Loew, Kirk P. Bernadino Background: Side-viewing duodenoscopes are absolutely necessary for successful ERCP. Holding or achieving proper positioning is often problematic making successful ERCP difficult or at times impossible. A variable stiffness therapeutic duodenoscope (VSTD) has been developed to address these problems. Patients: 468 consecutive patients undergoing ERCP were begun with standard therapeutic instruments. Cases which proved to be very difficult or not possible in achieving proper position or advancement were noted and the instrument exchanged for the VSTD. Methods: In all cases patients remained in the prone position. The relaxed VSTD was introduced and stiffened after straightening in the stomach. Continued inability to pass into the duodenum due to stricturing was treated with 48Fr guidewire balloon (Hobbs Medical) dilation. To prevent inadvertent withdrawal of the endoscope tip after advancement into position, gradual pulling back of the stiffened insertion tube was coupled with clockwise rotation throughout the maneuver. This 360 degree twisting motion effectively straightens the endoscope shaft to maintain maximal forward tip position to then permit cannulation (‘‘around-the-world’’ maneuver). Results: 35/468 (7.5%) pts met criteria and the VSTD was introduced. 11/35 (31%) had unstable position, 5/35 (14%) had difficulty secondary to prior surgery, 4/35 (11%) had abnormal anatomy, and 26/35 (74%) had duodenal stricturing or encasement. Nine of these patients had more than one problem. In cases requiring VSTD, 35/35 (100%) had a successful ERCP after maximally stiffening the control knob to either hold the instrument in proper position or permit advancement through strictures or encased duodenums. In pts with duodenal obstruction, balloon dilation to 48Fr was performed in 20/26 (77%). One duodenal perforation occurred due to the balloon dilation but no complications were noted due to the advancement or use of the VSTD. Conclusion: A variable stiffness therapeutic duodenoscope can permit successful ERCP due to stabilization of a difficult position or advancement through a strictured or encased duodenum. Balloon dilation is necessary in most cases of duodenal obstruction. 7.5% of consecutive patients referred to a tertiary center appeared to benefit from this new technology.
www.giejournal.org
T1458 A Pilot Trial Study to Assess Safety and Efficacy of Carbon Dioxide Insufflation During Colorectal Endoscopic Submucosal Dissection Yutaka Saito, Toshio Uraoka, Takahisa Matsuda, Fabian Emura, Hisatomo Ikehara, Yumi Mashimo, Tsuyoshi Kikuchi, Takahiro Kozu, Daizo Saito Introduction: In colonoscopy, carbon dioxide (CO2) insufflation is safe and effective in reducing patient discomfort, but air insufflation is still the standard method and there are no reports about its use during lengthy colonoscopic procedures. Some colonoscopists have performed endoscopic submucosal dissection (ESD) of large superficial colorectal lesions using air insuflation, but this usually causes severe abdominal discomfort. In addition, perforations, subcutaneous emphysema and pneumothorax have been reported in colorectal ESDs. Aims & Methods: In assessing safety and efficacy of CO2 instead of air insufflation during colorectal ESD, 36 patients were enrolled in this study. Informed consent was obtained from every patient. Arterial pCO2 was measured before and after the procedures. Each patient’s pain score (ordinary scale: 1 Z none, 2 Z mild, 3 Z moderate, 4 Z severe, 5 Z extreme) was recorded immediately after ESD with the total dose of midazolam (mg) used as the index for pain and discomfort. Colorectal ESD using air insufflation was performed on 35 other patients serving as the control group. Results: The mean operation time was 90 G 57 minutes (mean G SD) in the CO2 group and 100 G 80 minutes in the control group. In the CO2 group, arterial pCO2 was slightly elevated (mean G SD: 4.5 G 5.4 mmHg) and two patients experienced nausea and mild abdominal distension. In the CO2 group, the mean dose of midazolam was significantly lower; 5.6 G 4.9 mg vs. 9.7 G 5.9 mg in the control group (p ! 0.05). There were no perforations in the CO2 group while four perforations and one case of subcutaneous emphysema were observed in the control group. Conclusion: Patient discomfort in the CO2 group was considerably lower and risk of complications such as subcutaneous emphysema and pneumothorax also may have been less probably due to rapid absorption of CO2. Based on this pilot study, CO2 insufflation is safe and effective during lengthy colonoscopic procedures like ESD.
T1459 Usefulness and Safety of a Bipolar Current Needle Knife in Endoscopic Submucosal Dissection (ESD) Procedures for Large Colorectal Tumors Toshio Uraoka, Yutaka Saito, Takahisa Matsuda, Takuji Gotoda, Hisatomo Ikehara, Yumi Mashimo, Yasushi Sano, Toshihiko Doi, Daizo Saito Background: En bloc resections using the endoscopic submucosal dissection (ESD) procedure provide more accurate histological assessments and reduce local recurrences even for large colorectal lesions R20 mm. ESDs are more difficult than conventional endoscopic mucosal resections (EMR), however, with a higher incidence of complications especially perforations because of the colorectum’s bending and thinner walls. Several electronic devices using monopolar current have been used for ESDs, but here we introduce a new needle knife using bipolar current (B-KnifeÔ, Zeon Medical Inc., Tokyo, Japan) for ESDs of large colorectal tumors R20 mm. The B-knife has been designed so high-frequency current sent to the muscle layer is reduced for better control and safer use with the current flowing back from the knife towards the sheath tip. This study’s aim is to assess the clinical usefulness and safety of the B-knife in ESDs of large colorectal tumors R20 mm. Method: Between April and September 2005, 37 colorectal tumors R20 mm were treated with ESDs using the B-knife (B Group) at the National Cancer Center Hospital (NCCH) in Tokyo. From April 2004 to March 2005, we identified 35 colorectal tumors treated with ESDs using an electronic knife with monopolar current (Flex KnifeÔ, Olympus Corp., Tokyo, Japan) (M Group) at NCCH. This study compares rates of en bloc resection, procedure times, rates of associated complications and inflammatory reactions, as evidenced by next day blood examinations for C-reactive protein, for the two groups. Results: Mean tumor size in B Group was larger than M Group (34.4 mm [range: 20-100 mm] vs. 28.2 mm [20-55 mm]). The en bloc resection rate, median procedure time, rate of associated complications and increased ratio of C-reactive protein (after/before) were 92%, 80 minutes, 2.7% (1/37; one perforation) and 3.6, respectively, in B Group and 74%, 90 minutes, 8.6% (3/35; three perforations) and 5.5, respectively, in M Group. Conclusions: Based on our retrospective study’s results, use of the B-knife to perform ESDs of large colorectal tumors R20 mm appears to be safe and more effective than other electronic devices using monopolar current.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB231
T1456 A Novel Method for Determining the Inner Diameter of the Esophageal Body Using a Non-Compliant Balloon Catheter and Pressure/Volume Monitoring and Inflation System Michael B. Kimmey, Robert A. Ganz, Ronald E. Pruitt, Alvaro Reymunde, Virender K. Sharma, David E. Fleischer Background: Esophageal physiological testing includes manometry, 24-hr pH, esophagram, and impedance testing. More recently, it is possible to measure the inner diameter (ID) of the esophageal body (EB) using a non-compliant balloon with a pressure/volume monitoring/inflation system. Methods: This technology was developed as an adjunct to balloon-based ablation of Barrett’s esophagus (BE) ˆRRX Medical, Sunnyvale, CA). Prior to using the HALO360 Ablation System (BA ablation, ID measurement of the EB is required to: 1) select an ablation balloon size that fits the targeted EB, to ensure electrode contact and mitigate against overstretch, and 2) set ablation energy density (J/cm2) based on the EB ID. The sizing catheter has a non-compliant balloon with outer diameter (OD) 33.7 mm and length 4 cm. Calibration is first performed to record the balloon volume at 4 psi (HALO360 generator). The calibrated (deflated) balloon is passed over a wire, positioned in the EB (5-cm proximal to the top of the BE in cases of ablation), autoinflated to 4 psi, held at steady state for w3 seconds, then auto-deflated. The system displays ID (mm), based on pressure/volume at steady state. Prior to human use, a bench model using 24 cylinders of varying ID (22-33.5 mm) were measured with the system and results of measured vs. actual ID were compared. Thereafter, the system was evaluated in patients undergoing ablation of BE, comparing measured ID, selected ablation balloon ID, and ablation effect. Results: In the cylinder testing, 72 measurements were obtained. The median difference between measured and actual ID was -0.3 mm (IQR -0.5 to 0.0) or -1.2% (IQR -1.7 to 0.0). Thereafter, 238 measurements were made in 34 patients who were undergoing ablation. In the first 20 patients, balloon migration occurred near the gastroesophageal junction (GEJ), confounding measurements. In the final 14 patients, starting higher in the EB resulting in highly reproducible EB ID estimates (median EB ID 25.9 mm, range 21.7-32.6). In 14/14 (100%) cases, an accurate estimate of targeted EB ID was achieved, based on subsequent electrode size and effect. Conclusion: This is the first report of a novel method for measuring the ID in the EB. The results are accurate (within 0.3 mm) and reproducible, and the device is now implemented as an adjunct to ablation of BE (HALO360 Ablation System). Other potential applications may include characterization of non-cardiac CP, quantifying success of stricture dilation, and assessing complications of gastric bypass, fundoplication, and surgical anastomoses.
T1457 Variable Stiffness Therapeutic Duodenoscope (VSTD): Is It Useful? Michael K. Sanders, Douglas a. Howell, Burr J. Loew, Kirk P. Bernadino Background: Side-viewing duodenoscopes are absolutely necessary for successful ERCP. Holding or achieving proper positioning is often problematic making successful ERCP difficult or at times impossible. A variable stiffness therapeutic duodenoscope (VSTD) has been developed to address these problems. Patients: 468 consecutive patients undergoing ERCP were begun with standard therapeutic instruments. Cases which proved to be very difficult or not possible in achieving proper position or advancement were noted and the instrument exchanged for the VSTD. Methods: In all cases patients remained in the prone position. The relaxed VSTD was introduced and stiffened after straightening in the stomach. Continued inability to pass into the duodenum due to stricturing was treated with 48Fr guidewire balloon (Hobbs Medical) dilation. To prevent inadvertent withdrawal of the endoscope tip after advancement into position, gradual pulling back of the stiffened insertion tube was coupled with clockwise rotation throughout the maneuver. This 360 degree twisting motion effectively straightens the endoscope shaft to maintain maximal forward tip position to then permit cannulation (‘‘around-the-world’’ maneuver). Results: 35/468 (7.5%) pts met criteria and the VSTD was introduced. 11/35 (31%) had unstable position, 5/35 (14%) had difficulty secondary to prior surgery, 4/35 (11%) had abnormal anatomy, and 26/35 (74%) had duodenal stricturing or encasement. Nine of these patients had more than one problem. In cases requiring VSTD, 35/35 (100%) had a successful ERCP after maximally stiffening the control knob to either hold the instrument in proper position or permit advancement through strictures or encased duodenums. In pts with duodenal obstruction, balloon dilation to 48Fr was performed in 20/26 (77%). One duodenal perforation occurred due to the balloon dilation but no complications were noted due to the advancement or use of the VSTD. Conclusion: A variable stiffness therapeutic duodenoscope can permit successful ERCP due to stabilization of a difficult position or advancement through a strictured or encased duodenum. Balloon dilation is necessary in most cases of duodenal obstruction. 7.5% of consecutive patients referred to a tertiary center appeared to benefit from this new technology.
www.giejournal.org
T1458 A Pilot Trial Study to Assess Safety and Efficacy of Carbon Dioxide Insufflation During Colorectal Endoscopic Submucosal Dissection Yutaka Saito, Toshio Uraoka, Takahisa Matsuda, Fabian Emura, Hisatomo Ikehara, Yumi Mashimo, Tsuyoshi Kikuchi, Takahiro Kozu, Daizo Saito Introduction: In colonoscopy, carbon dioxide (CO2) insufflation is safe and effective in reducing patient discomfort, but air insufflation is still the standard method and there are no reports about its use during lengthy colonoscopic procedures. Some colonoscopists have performed endoscopic submucosal dissection (ESD) of large superficial colorectal lesions using air insuflation, but this usually causes severe abdominal discomfort. In addition, perforations, subcutaneous emphysema and pneumothorax have been reported in colorectal ESDs. Aims & Methods: In assessing safety and efficacy of CO2 instead of air insufflation during colorectal ESD, 36 patients were enrolled in this study. Informed consent was obtained from every patient. Arterial pCO2 was measured before and after the procedures. Each patient’s pain score (ordinary scale: 1 Z none, 2 Z mild, 3 Z moderate, 4 Z severe, 5 Z extreme) was recorded immediately after ESD with the total dose of midazolam (mg) used as the index for pain and discomfort. Colorectal ESD using air insufflation was performed on 35 other patients serving as the control group. Results: The mean operation time was 90 G 57 minutes (mean G SD) in the CO2 group and 100 G 80 minutes in the control group. In the CO2 group, arterial pCO2 was slightly elevated (mean G SD: 4.5 G 5.4 mmHg) and two patients experienced nausea and mild abdominal distension. In the CO2 group, the mean dose of midazolam was significantly lower; 5.6 G 4.9 mg vs. 9.7 G 5.9 mg in the control group (p ! 0.05). There were no perforations in the CO2 group while four perforations and one case of subcutaneous emphysema were observed in the control group. Conclusion: Patient discomfort in the CO2 group was considerably lower and risk of complications such as subcutaneous emphysema and pneumothorax also may have been less probably due to rapid absorption of CO2. Based on this pilot study, CO2 insufflation is safe and effective during lengthy colonoscopic procedures like ESD.
T1459 Usefulness and Safety of a Bipolar Current Needle Knife in Endoscopic Submucosal Dissection (ESD) Procedures for Large Colorectal Tumors Toshio Uraoka, Yutaka Saito, Takahisa Matsuda, Takuji Gotoda, Hisatomo Ikehara, Yumi Mashimo, Yasushi Sano, Toshihiko Doi, Daizo Saito Background: En bloc resections using the endoscopic submucosal dissection (ESD) procedure provide more accurate histological assessments and reduce local recurrences even for large colorectal lesions R20 mm. ESDs are more difficult than conventional endoscopic mucosal resections (EMR), however, with a higher incidence of complications especially perforations because of the colorectum’s bending and thinner walls. Several electronic devices using monopolar current have been used for ESDs, but here we introduce a new needle knife using bipolar current (B-KnifeÔ, Zeon Medical Inc., Tokyo, Japan) for ESDs of large colorectal tumors R20 mm. The B-knife has been designed so high-frequency current sent to the muscle layer is reduced for better control and safer use with the current flowing back from the knife towards the sheath tip. This study’s aim is to assess the clinical usefulness and safety of the B-knife in ESDs of large colorectal tumors R20 mm. Method: Between April and September 2005, 37 colorectal tumors R20 mm were treated with ESDs using the B-knife (B Group) at the National Cancer Center Hospital (NCCH) in Tokyo. From April 2004 to March 2005, we identified 35 colorectal tumors treated with ESDs using an electronic knife with monopolar current (Flex KnifeÔ, Olympus Corp., Tokyo, Japan) (M Group) at NCCH. This study compares rates of en bloc resection, procedure times, rates of associated complications and inflammatory reactions, as evidenced by next day blood examinations for C-reactive protein, for the two groups. Results: Mean tumor size in B Group was larger than M Group (34.4 mm [range: 20-100 mm] vs. 28.2 mm [20-55 mm]). The en bloc resection rate, median procedure time, rate of associated complications and increased ratio of C-reactive protein (after/before) were 92%, 80 minutes, 2.7% (1/37; one perforation) and 3.6, respectively, in B Group and 74%, 90 minutes, 8.6% (3/35; three perforations) and 5.5, respectively, in M Group. Conclusions: Based on our retrospective study’s results, use of the B-knife to perform ESDs of large colorectal tumors R20 mm appears to be safe and more effective than other electronic devices using monopolar current.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB231