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First Experience with a New Endoscopic Suture Device (ESD) for Endoscopic, Endoluminal Therapy of GERD
*W1521 Does Endoscopy Alter Management for Uncomplicated Gastroesophageal Reflux Disease? Graham B. Turner, Tony C. K. Tham Background: The role of endoscopy for patients with uncomplicated gastroesophageal reflux disease, ie. without alarm symptoms, is unclear particularly under the age of 55 years. We report the influence of endoscopy on the management of 100 patients with uncomplicated reflux symptoms. Methods: One hundred consecutive patients undergoing diagnostic upper gastrointestinal endoscopy solely for uncomplicated reflux symptoms were identified using a prospective endoscopy database. Endoscopy results letters were reviewed and, if necessary, the clinical notes were used to identify anti-secretory therapy prior to and after endoscopy. Age, other pathology and post-procedure instructions were assessed. The cost of anti-secretory therapy was calculated for therapy prior to endoscopy and for the recommended medication after. Results: Median age was 52 years, 56% of patients were under the age of 55. Only nine percent had no change in management. Anti-secretory therapy was reduced in 41% (1 stopped, 2 changed to lower dose proton pump inhibitor (PPI) and 38 were changed to ‘on-demand’ PPI). Therapy was increased in the other 50% (2 on ranitidine, 2 on ‘on-demand’ PPI, 30 on PPI and 16 on long-term PPI). For 9 patients this increase was for other reasons (gastroduodenal ulceration in 3, duodenitis in 3 and aspirin in 3). Columnar epithelium was identified in 9% and Barrett’s esophagus was confirmed in 5%. Patients under 55 years had anti-secretory therapy increased in 43% and reduced in 52%. Over 55 years, 59% had their therapy increased and 27% had it reduced. For the under 55 age group there was a saving in the cost of prescribed drugs of $295 per patient in the first 2 years, $451 over 3 years and $606 over 4 years. Endoscopy at our unit costs $490 and after 3 and 1/4 years this is equalled by the savings from reduction in prescribing. Conclusion: Endoscopy for uncomplicated reflux symptoms led to a change in management in 91% of cases. For patients under the age of 55 more than half had a reduction in the use of proton pump inhibitor therapy following endoscopy and this could lead to substantial financial savings. We conclude that endoscopy changes management in uncomplicated reflux disease and that it may be cost-effective in younger patients.
*W1523 Extended (48 hr) Monitoring in Patients with Extra-esophageal Manifestations of GERD Sami R. Achem, Mark E. Stark, Dawn D. Ferguson, Eric M. Ward, Diane M. Davis, Susan I. Nedrow, Ernest P. Bouras, Herbert C. Wolfsen, David S. Loeb, Kenneth R. DeVault Introduction: The evaluation of patients with extra-esophageal manifestations of gastro-esophageal reflux (GERD) frequently requires pH testing. The recent development of a tubeless radio-telemetry system allows for monitoring of esophageal pH for more than 24-hours. Whether this extended period of evaluation affords an expanded diagnostic confidence in this population has not been determined. Methods: Consecutive patients referred for tubeless ambulatory pH testing for evaluation of suspected extra-esophageal GERD over a 9-month period were included in the study. The monitoring device was attached to the esophagus 6 cm above the squamo-columnar junction after endoscopic localization. The total % esophageal acid exposure was evaluated in the first 24 hours, second 24 hours and for the total 48 hours of the study. Studies were considered normal if the total esophageal acid exposure was below the published upper limits of normal (5.33%) for the total monitoring period and each of the two 24 hour sub-periods. Likewise, a study was considered abnormal if all of the period’s acid exposures were above 5.33%. Studies were considered discordant when one of the study periods was normal and the other abnormal. Patients referred to evaluate the efficacy of acid suppressive therapy (medications or surgery) were also included in this study. Results: During the study period 115 patients were evaluated for suspected GERD. 36 for typical GERD (excluded from subsequent analysis) and 79 for extra-esophageal GERD (chest pain 45, pulmonary 21, ENT 13). Three patients were excluded due to failure to capture data in the second 24 hrs. The data in the remaining 76 patients are shown in the table. Of the patients with discordant results 8 were positive on day 1 and negative on day 2 and 6 negative on day 1 and positive on day 2. In these patients the composite 48-hour exposure was abnormal in 7. In patients studied to evaluate acid control (13 on double-dose PPI, one after Nissen fundoplication), 12 (85.7%) had good acid suppression in all three study periods. All patients completed the study satisfactorily and no major side-effects were observed. Summary: Extended evaluation beyond 24 hours increases the diagnostic yield of pH testing and should improve the sensitivity of ambulatory pH monitoring. This test also provides valuable information in the assessment of acid suppression therapies.
*W1522 Study of a Role of Salivary Secretion in Reflux Esophagitis in Patients with Scleroderma Tomohiro Kato, Hiroshi Araki, Minoru Nakai, Takafumi Naiki, Takahiko Asano, Hideki Hayashi, Tomoo Naito, Ichiro Yasuda, Masahito Nagaki, Hisataka Moriwaki (Background) It is well known that esophageal dysmotility and decrease of salivary secretion (SS) are relatively common in patients with scleroderma. Esophageal motility and SS are considered as defense factors against reflux esophagitis. In this study we investigated the role of SS in reflux esophagitis in patients with scleroderma. (Patients and methods) Subjects were 23 screloderma patients who underwent gastrointestinal endoscopy. We measured their SS and performed esophageal manometry. One male and twenty-two females whose average age was 64 years (range 47-77) were studied. The measurement of quantity of SS was estimated with Saxon’s test. Primary peristaltic pressures (PPs) at the esophageal body and the lower esophageal sphincter pressure (LESP) were taken. Evaluations of endoscopic findings were grouped according to LA classification. (Results) Symptom of heartburn was noted in 15 patients out of all 23 subjects (65%). Endoscopic findings were 17 Grade O (NERD), 1 Grade A, 1 Grade B, and 4 Grade C. Total amount of SS was 1.6 6 1.2 g (M 6 SD)(range 0.1-5.0 g). We classified our patients into 3 groups according to the total amount of SS. Heartburn was observed in 8 (88.9%) of 9 patients whose quantity of SS was less than 1.0 g, and Grade C was found in 3 of these patients. Three patients of 7 whose quantity of SS was 1.0-2.0 g, complained of heartburn, and all these patients were Grade C. In 2 patients of 7 whose quantity of SS was over 2.0 g, which was considered to be normal range, Grade C was observed. On the other hand, although the total amount of SS in 5 severe reflux esophagitis (Grade C) patients was 1.26 6 0.87, that in 18 patients with mild reflux esophagitis (Grade O, A, B) was 1.70 6 0.30. There was statistically no difference in total amount of SS between the two groups. Among the group of all patients, the total amount of SS in patients without heartburn (2.21 6 1.0) was statistically higher (P<0.05) than that in patients with heartburn (1.26 6 0.52). No difference between symptom(s) and lower esophageal PPs and LESP achieved statistical significance. (Conclusion) In scleroderma patients with severe decrease in SS (less than 1.0 g) a relationship between decrease in SS and the symptom of heartburn was suggested. Decrease in SS might be considered an important factor against reflux esophagitis in scleroderma patients.
P246
GASTROINTESTINAL ENDOSCOPY
*W1524 First Experience with a New Endoscopic Suture Device (ESD) for Endoscopic, Endoluminal Therapy of GERD Dieter Schilling, Ralf Kiesslich, Peter R. Galle, Juergen Riemann Introduction: Endoluminal gastroplication involves placement of sutures at the gastroesophageal junction to create an anti-reflux barrier. The aim of our prospective study was to analyse the technical feasibility and safety of the new Endoscopic Suture Device (ESD; Wilson and CookÒ). Patients and Methods: So far, 11 patients (6 women; 23-56 years) with reflux esophagitis #II8, hiatal hernia #3cm and with abnormal acid exposure (pH-measurements) were enrolled into this study. Therapeutic endoscopy (propofol sedation) was performed by the help of a flexible suture and the ti-knot device, which was introduced over an external accessory channel, fixed on the endoscope. 2-3 Sutures were applied in a circular fashion at the GE-junction. Technical feasibility parameters included procedure time, complications, patients questionnaire and 4-weeks follow-up. Results: Mean procedure time was 40 minutes (28 - 60 minutes) with excellent view during application of the sutures due to the accessory channel. Complications: In one case little bleeding occured after sewing, which could be stopped by injection therapy through the working channel of the endoscope. In another case the threads after sewing could not be cut by the help of the ti-knot. Thus, the threads were cut with the cutter of the EndoloopÒ-Device. Patient questionnaire: Immediately post procedure, transient complaints including vomiting, abdominal pain, chest soreness occurred in 7 of 11 cases (63.6%). In three patients (27%) 6 sutures were lost at the first endoscopic control after 4 weeks. Conclusion: ESD is a new device for endoluminal gastroplication. The technical application is easy with only minor complications. But first experience shows an early loss of sutures. However, the clinical efficiency in reflux disease can only be determined in longer follow-up.
VOLUME 59, NO. 5, 2004
*W1523 Extended (48 hr) Monitoring in Patients with Extra-esophageal Manifestations of GERD Sami R. Achem, Mark E. Stark, Dawn D. Ferguson, Eric M. Ward, Diane M. Davis, Susan I. Nedrow, Ernest P. Bouras, Herbert C. Wolfsen, David S. Loeb, Kenneth R. DeVault Introduction: The evaluation of patients with extra-esophageal manifestations of gastro-esophageal reflux (GERD) frequently requires pH testing. The recent development of a tubeless radio-telemetry system allows for monitoring of esophageal pH for more than 24-hours. Whether this extended period of evaluation affords an expanded diagnostic confidence in this population has not been determined. Methods: Consecutive patients referred for tubeless ambulatory pH testing for evaluation of suspected extra-esophageal GERD over a 9-month period were included in the study. The monitoring device was attached to the esophagus 6 cm above the squamo-columnar junction after endoscopic localization. The total % esophageal acid exposure was evaluated in the first 24 hours, second 24 hours and for the total 48 hours of the study. Studies were considered normal if the total esophageal acid exposure was below the published upper limits of normal (5.33%) for the total monitoring period and each of the two 24 hour sub-periods. Likewise, a study was considered abnormal if all of the period’s acid exposures were above 5.33%. Studies were considered discordant when one of the study periods was normal and the other abnormal. Patients referred to evaluate the efficacy of acid suppressive therapy (medications or surgery) were also included in this study. Results: During the study period 115 patients were evaluated for suspected GERD. 36 for typical GERD (excluded from subsequent analysis) and 79 for extra-esophageal GERD (chest pain 45, pulmonary 21, ENT 13). Three patients were excluded due to failure to capture data in the second 24 hrs. The data in the remaining 76 patients are shown in the table. Of the patients with discordant results 8 were positive on day 1 and negative on day 2 and 6 negative on day 1 and positive on day 2. In these patients the composite 48-hour exposure was abnormal in 7. In patients studied to evaluate acid control (13 on double-dose PPI, one after Nissen fundoplication), 12 (85.7%) had good acid suppression in all three study periods. All patients completed the study satisfactorily and no major side-effects were observed. Summary: Extended evaluation beyond 24 hours increases the diagnostic yield of pH testing and should improve the sensitivity of ambulatory pH monitoring. This test also provides valuable information in the assessment of acid suppression therapies.
*W1522 Study of a Role of Salivary Secretion in Reflux Esophagitis in Patients with Scleroderma Tomohiro Kato, Hiroshi Araki, Minoru Nakai, Takafumi Naiki, Takahiko Asano, Hideki Hayashi, Tomoo Naito, Ichiro Yasuda, Masahito Nagaki, Hisataka Moriwaki (Background) It is well known that esophageal dysmotility and decrease of salivary secretion (SS) are relatively common in patients with scleroderma. Esophageal motility and SS are considered as defense factors against reflux esophagitis. In this study we investigated the role of SS in reflux esophagitis in patients with scleroderma. (Patients and methods) Subjects were 23 screloderma patients who underwent gastrointestinal endoscopy. We measured their SS and performed esophageal manometry. One male and twenty-two females whose average age was 64 years (range 47-77) were studied. The measurement of quantity of SS was estimated with Saxon’s test. Primary peristaltic pressures (PPs) at the esophageal body and the lower esophageal sphincter pressure (LESP) were taken. Evaluations of endoscopic findings were grouped according to LA classification. (Results) Symptom of heartburn was noted in 15 patients out of all 23 subjects (65%). Endoscopic findings were 17 Grade O (NERD), 1 Grade A, 1 Grade B, and 4 Grade C. Total amount of SS was 1.6 6 1.2 g (M 6 SD)(range 0.1-5.0 g). We classified our patients into 3 groups according to the total amount of SS. Heartburn was observed in 8 (88.9%) of 9 patients whose quantity of SS was less than 1.0 g, and Grade C was found in 3 of these patients. Three patients of 7 whose quantity of SS was 1.0-2.0 g, complained of heartburn, and all these patients were Grade C. In 2 patients of 7 whose quantity of SS was over 2.0 g, which was considered to be normal range, Grade C was observed. On the other hand, although the total amount of SS in 5 severe reflux esophagitis (Grade C) patients was 1.26 6 0.87, that in 18 patients with mild reflux esophagitis (Grade O, A, B) was 1.70 6 0.30. There was statistically no difference in total amount of SS between the two groups. Among the group of all patients, the total amount of SS in patients without heartburn (2.21 6 1.0) was statistically higher (P<0.05) than that in patients with heartburn (1.26 6 0.52). No difference between symptom(s) and lower esophageal PPs and LESP achieved statistical significance. (Conclusion) In scleroderma patients with severe decrease in SS (less than 1.0 g) a relationship between decrease in SS and the symptom of heartburn was suggested. Decrease in SS might be considered an important factor against reflux esophagitis in scleroderma patients.
P246
GASTROINTESTINAL ENDOSCOPY
*W1524 First Experience with a New Endoscopic Suture Device (ESD) for Endoscopic, Endoluminal Therapy of GERD Dieter Schilling, Ralf Kiesslich, Peter R. Galle, Juergen Riemann Introduction: Endoluminal gastroplication involves placement of sutures at the gastroesophageal junction to create an anti-reflux barrier. The aim of our prospective study was to analyse the technical feasibility and safety of the new Endoscopic Suture Device (ESD; Wilson and CookÒ). Patients and Methods: So far, 11 patients (6 women; 23-56 years) with reflux esophagitis #II8, hiatal hernia #3cm and with abnormal acid exposure (pH-measurements) were enrolled into this study. Therapeutic endoscopy (propofol sedation) was performed by the help of a flexible suture and the ti-knot device, which was introduced over an external accessory channel, fixed on the endoscope. 2-3 Sutures were applied in a circular fashion at the GE-junction. Technical feasibility parameters included procedure time, complications, patients questionnaire and 4-weeks follow-up. Results: Mean procedure time was 40 minutes (28 - 60 minutes) with excellent view during application of the sutures due to the accessory channel. Complications: In one case little bleeding occured after sewing, which could be stopped by injection therapy through the working channel of the endoscope. In another case the threads after sewing could not be cut by the help of the ti-knot. Thus, the threads were cut with the cutter of the EndoloopÒ-Device. Patient questionnaire: Immediately post procedure, transient complaints including vomiting, abdominal pain, chest soreness occurred in 7 of 11 cases (63.6%). In three patients (27%) 6 sutures were lost at the first endoscopic control after 4 weeks. Conclusion: ESD is a new device for endoluminal gastroplication. The technical application is easy with only minor complications. But first experience shows an early loss of sutures. However, the clinical efficiency in reflux disease can only be determined in longer follow-up.
VOLUME 59, NO. 5, 2004