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Tu1396 Longer Term Follow up After Endoscopic Treatment of GERD With the Medigus SRS™ Endoscopic Stapling Device
Abstracts
(2 in dCRT VS 1 in non-dCRT group), 4 pneumonia and 3 GI hemorrhage. Overall complication rate was higher in dCRT group (55% VS 19% with p valueZ 0.017). Four patients (9.7%) had mild retrosternal pain. Recurrent dysphagia occurred in 14 patients (34.14% )[7 stent migrations and 7 tumor ingrowths]. Mean duration of recurrent dysphagia symptom after stent placement was 81 days (121.5 vs 18 days, dCRT vs non dCRT, respectively, pZ0.022). Overall survival was 102.11 days (106.55 in dCRT VS 92.78 days in non-dCRT with pZ 0.189). Conclusion: SEMs placement combined with definite chemoradiation is effective for palliation of dysphagia in advanced esophageal cancer. Dysphagia-free interval after SEMs placements was significantly longer after dCRT compared to those without. However, incidence of esophageal perforation and overall complication seem higher in SEMs after dCRT.
Tu1395 The Significance of POEM-Related Adverse Events Based on the Early Clinical Experience Su Jin Hong*, Joo Young Cho, MI-Young Kim, Jae Pil Han, Jun-Hyung Cho Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Seoul and Bucheon, Republic of Korea Backgrounds: Peroral endoscopic myotomy (POEM) is a novel endoscopic operation for achalasia patients. Adverse events including pneumomediastinum and subcutaneous emphysema can be detected in the perioperative period. The aim of this study was to investigate the frequency and importance of the perioperative adverse events in the early clinical experience of POEM. Methods: We collected the data of 34 POEM procedures of 31 achalasia patients who underwent POEM from November 2011 to September 2013 at Soonchunhyang University Seoul and Bucheon Hospital. Adverse events detected during the operation and post-operation periods were analyzed. Results: The enrolled patients had no adverse events during the operation. All adverse events were found in the post-operative period. The post-operative adverse events shown by simple x-ray included subcutaneous emphysema (9/34, 26.5%), pneumomediastinum (6/34, 17.6%), pneumoperitoneum (11/34, 32.4%), pneumoretroperitoneum (3/34, 8.8%), pleural effusion (11/34, 32.4%), and segmental atelectasis (10/34, 29.4%). A total of 15 patients received CT scans. Some subtle adverse events were detected on CT scans. However, most of adverse events detected by simple x-rays and CT scans were mild and they did not affect the clinical course of the patients. Esophagograms were routinely performed two days after POEM and showed no dye leakage in any patients including the patients who had subcutaneous emphysema, pneumomediastinum, pneumoperitoneum, and pneumoretroperitoneum. All adverse events were treated by conservative treatment. Conclusion: We conclude that mild forms of adverse events are frequently detected after POEM and they are easily treated by conservative treatment without interventional or surgical therapy.
Tu1396 Longer Term Follow up After Endoscopic Treatment of GERD With the Medigus SRSä Endoscopic Stapling Device William R. Kessler*1, Gail Mcnulty1, Don J. Selzer2, Glen a. Lehman1 1 Medicine - Gastroenterology & Hepatology, Indiana University Medical Center, Indianapolis, IN; 2Department of Surgery, Indiana University Medical Center, Indianapolis, IN Introduction: Gastroesophageal Reflux Disease (GERD) is a common problem. While the majority of patients are well controlled with medical therapy, surgical approaches are the mainstay for refractory disease and for patients wishing to avoid adverse effects and costs of long-term use of proton pump inhibitor therapy (PPI). Endoscopic approaches to the treatment of GERD include the Medigus SRSÔ stapling device which is a flexible surgical stapler, coupled with an endoscopic video camera and an endoscopic range finder, used to create an anterior fundoplication. Preliminary data from the multi-center pivotal trial has been published (Gastroenterology 2012;142(5):S1076) and resulted in FDA approval [510 (K):K120299;5/18/ 12]. We report three year results of patients treated with the SRSÔ system at our institution. Methods: In this prospective trial, patients with pH probe documented GERD with good response to PPI were treated with the SRSÔ device. Under general anesthesia, the Medigus SRSÔ was used to place 2-3 staple quintuplets to create an anterior fundoplication. A minimum of three years post-procedure GERD-HRQL scores, use of PPIs, H2RAs and antacids, and overall satisfaction were obtained by phone interview. No additional pH or endoscopic studies were done. Results: Twenty-two patients were treated at Indiana University with the SRSÔ device. One patient experienced a GI bleed 8 days after the procedure requiring blood transfusion. Bleeding stopped spontaneously and no therapy was required. Mean follow up GERD-HRQL scores, with baseline score measurement (on or off PPI, determined by PPI use at selected time point - year 1, 2 or 3) improved (See Table 1; Figure 1). The majority of patients were satisfied at 1, 2 and 3 years and remained off of daily PPI at all time points. Of patients taking any PPI post-stapling, mean omeprazole equivalent doses were decreased from baseline of 47.7 mg/d to 26.8 mg/day at one year, 19.7 mg/d at 2 years and 15.9 mg/d at 3 years. Discussion: At our institution the Medigus SRSÔ stapling device proved relatively safe and efficacious for patients with PPIresponsive, moderate-to-severe GERD. Fewer than 5% of patients experienced
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complications and 74% of patients remained off daily PPI at 3 years post-procedure. Further studies involving multiple centers, larger numbers of patients and appropriate control groups are required to better understand the future role of the Medigus SRSÔ device in endoluminal GERD therapy. Table 1. HRQL scores, patient satisfaction and PPI use after Medigus
SRSä stapling device. Year 1 Mean Score: Baseline
Year 2 Mean Score: Baseline
Year 3 Mean Score: Baseline
HRQL of 8.2 : 28.3 (nZ12) 5.1 : 29.7 (nZ13) 6.8 : 30.6 (nZ14) patients off daily PPI HRQL of 11.0 : 12.4 (nZ5) 8.4 : 11.0 (nZ5) 8.8 : 12.2 (nZ5) patients on daily PPI % of patients 67 (nZ12/18) 78 (nZ14/18) 63 (nZ12/19) satisfied % off daily PPI 67 (nZ12/18) 72 (nZ13/18) 74 (nZ14/19)
HRQL scores at baseline, years 1, 2 and 3 after Medigus SRSÔ stapling device.
Tu1397 Utility of NBI Magnifying Endoscopy in Patients With Reflux Disease- the Asian Perspective Choo Hean Poh*, Kwong Ming Fock, Daphne Ang, Jeannie Ong Gastroenterology, Changi General Hospital, Singapore, Singapore Background: Gastroesophageal reflux disease is a common gastrointestinal disorder in Asia. The diagnosis of erosive reflux disease (ERD) is based on the endoscopic detection of mucosal breaks at the squamocolumnar junction (SCJ). In patients with non-erosive reflux disease (NERD), endoscopy findings are normal. Patients with functional heartburn (normal endoscopy and pH-impedance study) are divided into hypersensitive esophagus where their symptoms correlated closely with reflux events and those with symptoms not related to reflux events. Recently, Rome III had incorporated hypersensitive esophagus with NERD because this phenotype response better to proton pump inhibitor (PPI). Narrow band imaging (NBI) had been used to examine patients with reflux. ERD and NERD patients were found to have increased number of dilated intrapapillary capillary loops (IPCLs), mucosal islands, microerosions and increased vascularity at the SCJ. Aim: To compare the NBI findings of patients with reflux (ERD and NERD) versus functional heartburn using NBI endoscopy. Method: Patients with persistent reflux were recruited in the study. Patients underwent conventional endoscopy and then NBI to visualise the mucosal surface at the SCJ. All patients were instructed to stop PPI for 2 weeks prior to evaluation. Patients’ demographic and reflux symptoms were recorded. All patients without esophagitis underwent manometry and pH impedance monitoring. Results: A total of 41 patients were included in the study (M/F 17/24, mean age 48.5 12.6 years old). 11 patients had esophagitis and the remaining 30 patients were subjected to manometry and 24 hour pH impedance monitoring. 12/30 (40%) of patients were NERD (5 true NERD and 7 hypersensitive esophagus) and 18/30 (60%) were functional heartburn. All patients in both ERD and NERD (23/41) had abnormal NBI findings with either dilated IPCL, island of mucosals or microerosions. In the functional heartburn group (18/41), 10 patients had normal NBI and 8 patients with abnormal NBI (4 patients had both dilated IPCLs and mucosal island, 3 had dilated IPCLs and 1 had mucosal island). Of these 8 patients with abnormal NBI, 2 had ineffective esophageal dysmotility on manometry. With the ineffective peristalsis, patients might have potential reflux which was not detected by impedance monitoring. Both of these patients had dilated IPCLs. Comparing GERD patients and those with functional heartburn, the presence of abnormal NBI was more prevalent in the former group, p !0.04. Conclusion: NBI magnifying endoscopy may
Volume 79, No. 5S : 2014 GASTROINTESTINAL ENDOSCOPY AB417
(2 in dCRT VS 1 in non-dCRT group), 4 pneumonia and 3 GI hemorrhage. Overall complication rate was higher in dCRT group (55% VS 19% with p valueZ 0.017). Four patients (9.7%) had mild retrosternal pain. Recurrent dysphagia occurred in 14 patients (34.14% )[7 stent migrations and 7 tumor ingrowths]. Mean duration of recurrent dysphagia symptom after stent placement was 81 days (121.5 vs 18 days, dCRT vs non dCRT, respectively, pZ0.022). Overall survival was 102.11 days (106.55 in dCRT VS 92.78 days in non-dCRT with pZ 0.189). Conclusion: SEMs placement combined with definite chemoradiation is effective for palliation of dysphagia in advanced esophageal cancer. Dysphagia-free interval after SEMs placements was significantly longer after dCRT compared to those without. However, incidence of esophageal perforation and overall complication seem higher in SEMs after dCRT.
Tu1395 The Significance of POEM-Related Adverse Events Based on the Early Clinical Experience Su Jin Hong*, Joo Young Cho, MI-Young Kim, Jae Pil Han, Jun-Hyung Cho Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Seoul and Bucheon, Republic of Korea Backgrounds: Peroral endoscopic myotomy (POEM) is a novel endoscopic operation for achalasia patients. Adverse events including pneumomediastinum and subcutaneous emphysema can be detected in the perioperative period. The aim of this study was to investigate the frequency and importance of the perioperative adverse events in the early clinical experience of POEM. Methods: We collected the data of 34 POEM procedures of 31 achalasia patients who underwent POEM from November 2011 to September 2013 at Soonchunhyang University Seoul and Bucheon Hospital. Adverse events detected during the operation and post-operation periods were analyzed. Results: The enrolled patients had no adverse events during the operation. All adverse events were found in the post-operative period. The post-operative adverse events shown by simple x-ray included subcutaneous emphysema (9/34, 26.5%), pneumomediastinum (6/34, 17.6%), pneumoperitoneum (11/34, 32.4%), pneumoretroperitoneum (3/34, 8.8%), pleural effusion (11/34, 32.4%), and segmental atelectasis (10/34, 29.4%). A total of 15 patients received CT scans. Some subtle adverse events were detected on CT scans. However, most of adverse events detected by simple x-rays and CT scans were mild and they did not affect the clinical course of the patients. Esophagograms were routinely performed two days after POEM and showed no dye leakage in any patients including the patients who had subcutaneous emphysema, pneumomediastinum, pneumoperitoneum, and pneumoretroperitoneum. All adverse events were treated by conservative treatment. Conclusion: We conclude that mild forms of adverse events are frequently detected after POEM and they are easily treated by conservative treatment without interventional or surgical therapy.
Tu1396 Longer Term Follow up After Endoscopic Treatment of GERD With the Medigus SRSä Endoscopic Stapling Device William R. Kessler*1, Gail Mcnulty1, Don J. Selzer2, Glen a. Lehman1 1 Medicine - Gastroenterology & Hepatology, Indiana University Medical Center, Indianapolis, IN; 2Department of Surgery, Indiana University Medical Center, Indianapolis, IN Introduction: Gastroesophageal Reflux Disease (GERD) is a common problem. While the majority of patients are well controlled with medical therapy, surgical approaches are the mainstay for refractory disease and for patients wishing to avoid adverse effects and costs of long-term use of proton pump inhibitor therapy (PPI). Endoscopic approaches to the treatment of GERD include the Medigus SRSÔ stapling device which is a flexible surgical stapler, coupled with an endoscopic video camera and an endoscopic range finder, used to create an anterior fundoplication. Preliminary data from the multi-center pivotal trial has been published (Gastroenterology 2012;142(5):S1076) and resulted in FDA approval [510 (K):K120299;5/18/ 12]. We report three year results of patients treated with the SRSÔ system at our institution. Methods: In this prospective trial, patients with pH probe documented GERD with good response to PPI were treated with the SRSÔ device. Under general anesthesia, the Medigus SRSÔ was used to place 2-3 staple quintuplets to create an anterior fundoplication. A minimum of three years post-procedure GERD-HRQL scores, use of PPIs, H2RAs and antacids, and overall satisfaction were obtained by phone interview. No additional pH or endoscopic studies were done. Results: Twenty-two patients were treated at Indiana University with the SRSÔ device. One patient experienced a GI bleed 8 days after the procedure requiring blood transfusion. Bleeding stopped spontaneously and no therapy was required. Mean follow up GERD-HRQL scores, with baseline score measurement (on or off PPI, determined by PPI use at selected time point - year 1, 2 or 3) improved (See Table 1; Figure 1). The majority of patients were satisfied at 1, 2 and 3 years and remained off of daily PPI at all time points. Of patients taking any PPI post-stapling, mean omeprazole equivalent doses were decreased from baseline of 47.7 mg/d to 26.8 mg/day at one year, 19.7 mg/d at 2 years and 15.9 mg/d at 3 years. Discussion: At our institution the Medigus SRSÔ stapling device proved relatively safe and efficacious for patients with PPIresponsive, moderate-to-severe GERD. Fewer than 5% of patients experienced
www.giejournal.org
complications and 74% of patients remained off daily PPI at 3 years post-procedure. Further studies involving multiple centers, larger numbers of patients and appropriate control groups are required to better understand the future role of the Medigus SRSÔ device in endoluminal GERD therapy. Table 1. HRQL scores, patient satisfaction and PPI use after Medigus
SRSä stapling device. Year 1 Mean Score: Baseline
Year 2 Mean Score: Baseline
Year 3 Mean Score: Baseline
HRQL of 8.2 : 28.3 (nZ12) 5.1 : 29.7 (nZ13) 6.8 : 30.6 (nZ14) patients off daily PPI HRQL of 11.0 : 12.4 (nZ5) 8.4 : 11.0 (nZ5) 8.8 : 12.2 (nZ5) patients on daily PPI % of patients 67 (nZ12/18) 78 (nZ14/18) 63 (nZ12/19) satisfied % off daily PPI 67 (nZ12/18) 72 (nZ13/18) 74 (nZ14/19)
HRQL scores at baseline, years 1, 2 and 3 after Medigus SRSÔ stapling device.
Tu1397 Utility of NBI Magnifying Endoscopy in Patients With Reflux Disease- the Asian Perspective Choo Hean Poh*, Kwong Ming Fock, Daphne Ang, Jeannie Ong Gastroenterology, Changi General Hospital, Singapore, Singapore Background: Gastroesophageal reflux disease is a common gastrointestinal disorder in Asia. The diagnosis of erosive reflux disease (ERD) is based on the endoscopic detection of mucosal breaks at the squamocolumnar junction (SCJ). In patients with non-erosive reflux disease (NERD), endoscopy findings are normal. Patients with functional heartburn (normal endoscopy and pH-impedance study) are divided into hypersensitive esophagus where their symptoms correlated closely with reflux events and those with symptoms not related to reflux events. Recently, Rome III had incorporated hypersensitive esophagus with NERD because this phenotype response better to proton pump inhibitor (PPI). Narrow band imaging (NBI) had been used to examine patients with reflux. ERD and NERD patients were found to have increased number of dilated intrapapillary capillary loops (IPCLs), mucosal islands, microerosions and increased vascularity at the SCJ. Aim: To compare the NBI findings of patients with reflux (ERD and NERD) versus functional heartburn using NBI endoscopy. Method: Patients with persistent reflux were recruited in the study. Patients underwent conventional endoscopy and then NBI to visualise the mucosal surface at the SCJ. All patients were instructed to stop PPI for 2 weeks prior to evaluation. Patients’ demographic and reflux symptoms were recorded. All patients without esophagitis underwent manometry and pH impedance monitoring. Results: A total of 41 patients were included in the study (M/F 17/24, mean age 48.5 12.6 years old). 11 patients had esophagitis and the remaining 30 patients were subjected to manometry and 24 hour pH impedance monitoring. 12/30 (40%) of patients were NERD (5 true NERD and 7 hypersensitive esophagus) and 18/30 (60%) were functional heartburn. All patients in both ERD and NERD (23/41) had abnormal NBI findings with either dilated IPCL, island of mucosals or microerosions. In the functional heartburn group (18/41), 10 patients had normal NBI and 8 patients with abnormal NBI (4 patients had both dilated IPCLs and mucosal island, 3 had dilated IPCLs and 1 had mucosal island). Of these 8 patients with abnormal NBI, 2 had ineffective esophageal dysmotility on manometry. With the ineffective peristalsis, patients might have potential reflux which was not detected by impedance monitoring. Both of these patients had dilated IPCLs. Comparing GERD patients and those with functional heartburn, the presence of abnormal NBI was more prevalent in the former group, p !0.04. Conclusion: NBI magnifying endoscopy may
Volume 79, No. 5S : 2014 GASTROINTESTINAL ENDOSCOPY AB417