- Email: [email protected]
⁎⁎⁎4469 Transoral endoscopic suturing for gastroesophageal reflux disease: a multicenter trial.
***4467 WIRELESS ENDOSCOPY. Paul Swain, Royal London Hosp, London, United Kingdom. Background: Miniaturization of electronic components might allow the development of a new type of wireless endoscopy. Advances in complementary metal oxide silicon (CMOS) technology allow high quality video images to be transmitted with much lower power consumption than with charge coupled devices (CCDs). Small bowel endoscopy is currently limited by problems of discomfort and failure to advance far into the small-bowel. Aim: To develop and test wireless capsule endoscopy. Methods: Using a CMOS imaging chip, miniature processor, white light emitting diode (LED) light source, short focal length lens, miniature transmitter and antenna powered by silver oxide batteries, a wireless capsule endoscope (Given Imaging) was constructed measuring 11 x 33 mm. Results: The video images were transmitted using a radio-frequency signal (approx. 410 MHz) at a rate of two frames per second to an array of aerials attached to the body which allowed image capture and were also used to calculate the position of the capsule in the body. The images were stored on a portable recorder carried on a belt and subsequently downloaded for analysis. The system allowed more than 5 hours of recording of images from the gastrointestinal tract. Live transmission of good quality video images were obtained for 6 hour periods in dogs. With ethical committee approval the first human volunteer studies were performed. The capsule was easily swallowed and caused no discomfort whatsoever. The capsule, propelled by peristalsis, successfully transmitted video images from the whole of the small bowel and reached the cecum in under 2 hours. The image window remained clear through out the whole of the transmissions. Trigonometric analysis of signal strength allowed continuous monitoring of anatomic endoscope position. Clear video images of the human small bowel were recorded from the pylorus to cecum. Conclusion: This study reports the development of a new type of endoscopy which for the first time allows painless endoscopic imaging of the whole of the small bowel for prolonged periods. Its development, testing and first application in man is described.
***4468 A RANDOMIZED CONTROLLED TRIAL COMPARING BOTULINUM TOXIN INJECTION TO PNEUMATIC DILATATION FOR TREATMENT OF ACHALASIA. Reza Malekzadeh, Javad Milkaeli, Ali Fazel, Ghodratollah Montazeri, Mohammad Yaghoobi, Morteza Khatibian, Reza Ansari, Homayoon Vahedi, Digest Diseases Research Ctr, Tehran Univ Med Sci, Tehran, Iran; Digest Diseases Research Ctr, Tehran Univ Med Sci, Teahran, Iran; Div of Gastroenterology, Saint Louis Univ Sch Medicine, Saint Louis, MO. Introduction: Achalasia is a well defined esophageal motor disorder. Available therapeutic options include surgical myotomy, pneumatic dilation, and more recently intrasphincter botulinum injection. Aim: To compare the efficacy of botulinum toxin injection and pneumatic dilatation in the treatment of achalasia. Methods: Thirty-nine consenting symptomatic adults newly diagnosed with achalasia were consecutively enrolled.The diagnosis was established based on clinical, radiologic, endoscopic and manometric criteria. Exclusion criteria included age less than forty, pregnancy, coagulopathy, serious medical illness or malignancy. Patients were randomized to receive either botulinu toxin injection (20 pats.) or pneumatic dilatation (19 pats.).Over a duration of 12 months, efficacy was assessed on the basis of an esophageal symptom score. Symptom scores were evaluated at 1,6 and 12 months. Clinical recurrence was defined as an increase of sympyom score to greater than 50% of baseline. If symptoms recurred, retreatment was administered with a second botulinum toxin injection or a second pneumatic dilatation. Clinical response to retreatment was followed for the remained of 1 year. If symptoms recurred after retreatment the patient was considered a treatment failure. The 1 year incidence of retreatment and treatment failure was estimated by the Kaplan-meier method. Results: The cumulative retreatment rate (relapse after 1 treatment session) was significantly higher in the botulinum toxin
VOLUME 51, NO. 4, PART 2, 2000
group than the pneumatic dilatation group (P<0.01). The estimated Kaplan-Meier one year incidence of retreatment in the botulinum toxin and pneumatic dilatation group were 85% and 47% respectively. The cumulative treatment failure rate (relapse after 2 treatment sessions) was significantly higher in the botulinum toxin group than the pneumatic dilatation group(P<0.01). The estimated Kaplan-Meier one year incidence of treatment failure in the botulinum toxin and pneumatic dilatation group were 40% and 0% respectively. The cumulative relapse rate after a single pneumatic dilatation (40%) was similatr to that achieved with two botulinum toxin injections(p=0.88). Conclusion: Treatment of achalasia with pneumatic dilation is more efficacious than botulinum toxin in providing sustained symptomatic relief over a one-year duration. The efficacy of a single pneumatic dilation is similar to that of two botulinum toxin injection.
***4469 TRANSORAL ENDOSCOPIC SUTURING FOR GASTROESOPHAGEAL REFLUX DISEASE: A MULTICENTER TRIAL. Charles J. Filipi, Steven A. Edmundowicz, Christopher J. Gostout, Glen A. Lehman, Isaac L. Raijman, Richard I. Rothstein, Greg V. Stiegman, Patrick J. Waring, Sharon A. Sweeney, Ken Dieselman, Donal Dunne, Creighton Univ, Omaha, NE; Washington Univ, St. Louis, MO; Mayo Clin, Rochester, MN; Indiana Univ, Indianapolis, IN; Park Plaza Med Ctr, Houston, TX; Dartmouth Hitchcock Med Ctr, Lebanon, NH; Colorado Univ, Denver, CO; Emory Univ, Atlanta, GA; C R BAAD, Inc, IN. Introduction: A totally transoral outpatient procedure for the treatment of gastroesophageal reflux disease (GERD) would be appealing to physicians and patients. Methods: A multicenter trial was initiated for 64 patients suffering from symptomatic GERD. Inclusion criteria were 3 or more heartburn episodes per week while off medication, dependency on antisecretory medicine and documented acid reflux by pH monitoring (pH < 4 for more than 4% of the total monitoring time). Exclusion criteria were age < 18, pregnancy, dysphagia, grade 3-4 esophagitis, obesity (BMI>40kg/ meter2) previous esophageal surgery and hiatus hernia > 2 cm. Patients underwent esophageal manometry, endoscopy, 24 hour pH monitoring and completed a MOS SF-36 quality of life (QOL) questionnaire and symptom severity scoring. Patients were then randomized to a linear or circumferential plication configuration group. After the endoscopic valvuloplasty patients repeated the (QOL) questionnaire and underwent endoscopy, manometry and 24 hour pH monitoring at 3 months and 6 months. All adverse procedural events were recorded. Symptom change scores were analyzed with the Wilcoxon signed-rank test. Procedural success was defined as patients that were symptom free with fewer than 4 doses of acid reduction medicine per month. Results: Sixty-two percent of patients experienced success at 3 months. Six month data are pending. Mean three month symptom change scores demonstrated procedural efficacy. GROUP MEAN VALUES Baseline, 3 months p (sign rank test): Heartburn score 62.5, 16.6, 0.0001, Heartburn frequency 2.8, 1.4, 0.0001, Heartburn severity 22.8, 9.2, 0.0001, Regurgitation 1.8, 0.6, 0.0001 respectively, Of those patients suffering with regurgitation (80%), more than one half (55%) reported they no longer suffer from this problem. Only patients with preprocedure acid reflux time > 10% had an improvement in % time pH < 4 (p=0.002). QOL data are yet to be analyzed. Plication configuration and number did not effect symptom improvement. One patient had a suture perforation of the distal esophagus that was successfully treated with antibiotics. Two patients experienced mucosal tears secondary to an overtube. No intervention was required and no symptoms resulted. Four patients experienced hypoxia during the procedure, one of which required a general anesthetic for a second procedure. All patients recovered without sequelae. Conclusion: Endoscopic valvuloplasty has minimal morbidity and is successful in controlling most symptoms at 3 month follow-up.
GASTROINTESTINAL ENDOSCOPY
AB143
***4468 A RANDOMIZED CONTROLLED TRIAL COMPARING BOTULINUM TOXIN INJECTION TO PNEUMATIC DILATATION FOR TREATMENT OF ACHALASIA. Reza Malekzadeh, Javad Milkaeli, Ali Fazel, Ghodratollah Montazeri, Mohammad Yaghoobi, Morteza Khatibian, Reza Ansari, Homayoon Vahedi, Digest Diseases Research Ctr, Tehran Univ Med Sci, Tehran, Iran; Digest Diseases Research Ctr, Tehran Univ Med Sci, Teahran, Iran; Div of Gastroenterology, Saint Louis Univ Sch Medicine, Saint Louis, MO. Introduction: Achalasia is a well defined esophageal motor disorder. Available therapeutic options include surgical myotomy, pneumatic dilation, and more recently intrasphincter botulinum injection. Aim: To compare the efficacy of botulinum toxin injection and pneumatic dilatation in the treatment of achalasia. Methods: Thirty-nine consenting symptomatic adults newly diagnosed with achalasia were consecutively enrolled.The diagnosis was established based on clinical, radiologic, endoscopic and manometric criteria. Exclusion criteria included age less than forty, pregnancy, coagulopathy, serious medical illness or malignancy. Patients were randomized to receive either botulinu toxin injection (20 pats.) or pneumatic dilatation (19 pats.).Over a duration of 12 months, efficacy was assessed on the basis of an esophageal symptom score. Symptom scores were evaluated at 1,6 and 12 months. Clinical recurrence was defined as an increase of sympyom score to greater than 50% of baseline. If symptoms recurred, retreatment was administered with a second botulinum toxin injection or a second pneumatic dilatation. Clinical response to retreatment was followed for the remained of 1 year. If symptoms recurred after retreatment the patient was considered a treatment failure. The 1 year incidence of retreatment and treatment failure was estimated by the Kaplan-meier method. Results: The cumulative retreatment rate (relapse after 1 treatment session) was significantly higher in the botulinum toxin
VOLUME 51, NO. 4, PART 2, 2000
group than the pneumatic dilatation group (P<0.01). The estimated Kaplan-Meier one year incidence of retreatment in the botulinum toxin and pneumatic dilatation group were 85% and 47% respectively. The cumulative treatment failure rate (relapse after 2 treatment sessions) was significantly higher in the botulinum toxin group than the pneumatic dilatation group(P<0.01). The estimated Kaplan-Meier one year incidence of treatment failure in the botulinum toxin and pneumatic dilatation group were 40% and 0% respectively. The cumulative relapse rate after a single pneumatic dilatation (40%) was similatr to that achieved with two botulinum toxin injections(p=0.88). Conclusion: Treatment of achalasia with pneumatic dilation is more efficacious than botulinum toxin in providing sustained symptomatic relief over a one-year duration. The efficacy of a single pneumatic dilation is similar to that of two botulinum toxin injection.
***4469 TRANSORAL ENDOSCOPIC SUTURING FOR GASTROESOPHAGEAL REFLUX DISEASE: A MULTICENTER TRIAL. Charles J. Filipi, Steven A. Edmundowicz, Christopher J. Gostout, Glen A. Lehman, Isaac L. Raijman, Richard I. Rothstein, Greg V. Stiegman, Patrick J. Waring, Sharon A. Sweeney, Ken Dieselman, Donal Dunne, Creighton Univ, Omaha, NE; Washington Univ, St. Louis, MO; Mayo Clin, Rochester, MN; Indiana Univ, Indianapolis, IN; Park Plaza Med Ctr, Houston, TX; Dartmouth Hitchcock Med Ctr, Lebanon, NH; Colorado Univ, Denver, CO; Emory Univ, Atlanta, GA; C R BAAD, Inc, IN. Introduction: A totally transoral outpatient procedure for the treatment of gastroesophageal reflux disease (GERD) would be appealing to physicians and patients. Methods: A multicenter trial was initiated for 64 patients suffering from symptomatic GERD. Inclusion criteria were 3 or more heartburn episodes per week while off medication, dependency on antisecretory medicine and documented acid reflux by pH monitoring (pH < 4 for more than 4% of the total monitoring time). Exclusion criteria were age < 18, pregnancy, dysphagia, grade 3-4 esophagitis, obesity (BMI>40kg/ meter2) previous esophageal surgery and hiatus hernia > 2 cm. Patients underwent esophageal manometry, endoscopy, 24 hour pH monitoring and completed a MOS SF-36 quality of life (QOL) questionnaire and symptom severity scoring. Patients were then randomized to a linear or circumferential plication configuration group. After the endoscopic valvuloplasty patients repeated the (QOL) questionnaire and underwent endoscopy, manometry and 24 hour pH monitoring at 3 months and 6 months. All adverse procedural events were recorded. Symptom change scores were analyzed with the Wilcoxon signed-rank test. Procedural success was defined as patients that were symptom free with fewer than 4 doses of acid reduction medicine per month. Results: Sixty-two percent of patients experienced success at 3 months. Six month data are pending. Mean three month symptom change scores demonstrated procedural efficacy. GROUP MEAN VALUES Baseline, 3 months p (sign rank test): Heartburn score 62.5, 16.6, 0.0001, Heartburn frequency 2.8, 1.4, 0.0001, Heartburn severity 22.8, 9.2, 0.0001, Regurgitation 1.8, 0.6, 0.0001 respectively, Of those patients suffering with regurgitation (80%), more than one half (55%) reported they no longer suffer from this problem. Only patients with preprocedure acid reflux time > 10% had an improvement in % time pH < 4 (p=0.002). QOL data are yet to be analyzed. Plication configuration and number did not effect symptom improvement. One patient had a suture perforation of the distal esophagus that was successfully treated with antibiotics. Two patients experienced mucosal tears secondary to an overtube. No intervention was required and no symptoms resulted. Four patients experienced hypoxia during the procedure, one of which required a general anesthetic for a second procedure. All patients recovered without sequelae. Conclusion: Endoscopic valvuloplasty has minimal morbidity and is successful in controlling most symptoms at 3 month follow-up.
GASTROINTESTINAL ENDOSCOPY
AB143