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Successful Ablation of Barrett's Esophagus (BE) with Low Grade Dysplasia (LGD) Using Barrx Bipolar Balloon Device: Preliminary Results of the Ablation of Intestinal Metaplasia with LGD (AIM-LDG) Trial
Abstracts
S1205 Successful Ablation of Barrett’s Esophagus (BE) with Low Grade Dysplasia (LGD) Using Barrx Bipolar Balloon Device: Preliminary Results of the Ablation of Intestinal Metaplasia with LGD (AIM-LDG) Trial Virender K. Sharma, Roxane McLaughlin, Patrick Dean, Giovanni De Petris, Michele M. Moirano, David E. Fleischer Aims: To evaluate the safety, tolerability & histological clearance of BE with LGD after ablation with the BARRx device. Methods: Prospective trial in patients with 2-6 cm of LGD on 2 EGD in previous 2 yrs, confirmed by 2 pathologists. The BARRx device consists of a bipolar electrode array encircling an esophageal balloon. All patients received 12 J/cm2 at 300W. All patients received lansoprazole 30 mg bid. Tolerability was assessed with 0-100 VAS for peri- and 2-hr post-procedure discomfort, & 14-day symptom diary. EGD at 1, 3, 6 mo with 4-quadrant, q 1 cm biopsies (bx) using maximum capacity forcep; interpreted by a single blinded pathologist. Outcomes were clearance of LGD & BE. Complete Response (CR) Z all bx negative & Partial Response (PR) Z 50-99% bx negative for the outcomes(LGD or IM). Patients with 3 mo CR will proceed to 6 mo EGDCbx. Patients with LGD or BE at 3 mo will be re-treated at 4 mo and undergo 6 mo EGDCbx. Results: Five of 10 planned patients (4 male, mean age 66 yrs, range 54-76, median BE 5 cm) have enrolled. Median procedure time Z 26 min (range 19-37). Ablation time Z 1 sec/3 cm treatment segment. All patients tolerated the procedure well, with low discomfort scores on the exit survey and 14-day diary (median scores !20 out of 100 for all outcomes, except sore throat, median 40/100 resolved by day 6). At 1-mo EGD, all patients had complete healing. EGD was normal in all but 1 patient (mild asymptomatic scarring at proximal edge of ablation zone). One patient had a small focus of Barrett with HGD at 1 and 3-mo that was presumably missed at enrollment (sampling error). He was excluded after 3-month follow-up and offered standard therapy. There were no ‘‘buried glands’’ in 94 follow-up bx. A single treatment resulted in 4 (80%) patients with CR of LGD, & 2 (40%) with CR of BE & 3 (60%) PR of BE (ITT analysis). Conclusion: Ablation of BE with LGD using the BARRx bipolar balloon device creates a circumferential ablation without significant complications or buried glands. The CR of LGD after a single 12 J/cm2 treatment with an intentional overlap is 80%. Complete ablation of BE (without LGD) was achieved in 40% while remaining 60% had only minute residual foci of BE. Patients with persistent disease will undergo a 2nd treatment. The pilot data suggests that the BARRx device can safely and effectively eliminate LGD and BE. Larger trials are planned to evaluate its effectiveness in reducing the progression of LGD to HGD and/or cancer.
S1206 Histological Results of EMR for Esophageal Lesions Diagnosed as High-Grade Intraepithelial Squamous Neoplasia by Endoscopic Biopsy Yuichi Shimizu, Mototsugu Kato, Junji Yamamoto, Yuji Ono, Takehiko Katsurada, Shouko Ono, Yasuaki Mori, Manabu Nakagawa, Souichi Nakagawa, Tomoo Itoh, Masahiro Asaka Background: The ability to detect early squamous neoplasia of the esophagus can be enhanced considerably by iodine staining during endoscopic examination. Histologically, biopsy specimens obtained from the lesion detected in endoscopic screening were often diagnosed as high-grade intraepithelial squamous neoplasia (WHO 1999). However, there are very few reports on the characteristics of such intraepithelial squamous lesions, and a management strategy for such lesions has therefore not been established. In this study, we prospectively performed EMR for esophageal lesions diagnosed as high-grade intraepithelial squamous neoplasia by endoscopic biopsy and investigated histological features of the lesions in totally resected specimens. Patients and Methods: During the period from April 2001 to September 2004, 51 patients were found to have lesions diagnosed as high-grade intraepithelial squamous neoplasia of the esophagus by endoscopic biopsy at Hokkaido University Hospital and associated hospitals. All patients underwent EUS with the use of a high-frequency catheter probe and were confirmed to have no evidence of submucosal tumor invasion. Subsequently, all patients underwent EMR at Hokkaido University Hospital. Results: Histological examination of totally resected specimens revealed that 12 (23.5%) of the 51 patients had tumor invasion of the basement membrane that was confined to the lamina propria mucosae and that 4 (7.8%) of the 51 patients had tumor invasion of the muscularis mucosae. The remaining 35 patients (68.6%) were confirmed to have high-grade intraepithelial squamous neoplasia of the esophagus. The invasive focus all of the 16 lesions of invasive squamous cell carcinoma was surrounded by high-grade intraepithelial squamous neoplasia. Conclusions: Histological results suggested that high-grade intraepithelial squamous neoplasia of the esophagus has characteristics of carcinoma in the pre-invasive stage. EMR, which can be employed both therapeutically and diagnostically, should be performed for esophageal lesions diagnosed by endoscopic biopsy as high-grade intraepithelial squamous neoplasia not only because of its probable malignant potential but also because over 30% of such lesions are actually invasive carcinoma.
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S1207 The Use of Removable Silicone Stents in Patients with Malignant Esophageal Obstruction: An Initial US Experience Ali Siddiqui, Robert Dudnick, Richard Peterson, Bruce Greenwald, Michel Kahaleh, Paul Yeaton, Oleh Haluszka, David Loren, Thomas Kowalski Background: The aims of this study are to report a multi-institutional experience with the Polyflex self-expanding silicone stent (Ru ¨ sch; Kernen Germany) in patients with malignant stenosis receiving chemoradiation prior to esophagectomy. Methods: A survey was developed to assess procedural success, restoration of oral nutrition, migration, and removal of the Polyflexaˆ stent. The survey was sent to regional institutions and retrospectively completed for all patients in whom the stent was placed for malignant esophageal obstruction. Results: 12 patients underwent Polyflexaˆ stent placement. 10 patients had adenocarcinoma and 2 patients had squamous carcinoma. Stent placement was successful in 11/12 patients (92%). The stricture could not be traversed with the delivery catheter in one patient. Restoration of oral nutrition following stent placement occurred in 10/11 patients (91%). Migration of the stent into the stomach occurred in 5 patients (45%) without occurrence of gastric outlet obstruction; there was no proximal migration. In all cases, migration occurred during neoadjuvant therapy and correlated with restoration of an esophageal lumen adequate for oral nutrition. The mean time from stent placement to migration was 23 days. Stents were successfully removed endoscopically or at the time of esophagectomy. Mean duration from stent placement to removal was 49 days. Conclusions: This early experience suggests that the removable silicone Polyflexaˆ stent is an effective alternative for the management of malignant esophageal stenosis in patients for whom neoadjuvant chemoradiation is planned prior to esophagectomy, and warrants further study.
S1208 Safety and Efficacy of Enteryx for Treatment of GERD in Patients with GERD and Asthma: A Pilot Study Joseph R. DePasquale, Gilbert Simoni, Sohail N. Shaikh, Richard A. Miller, Robert S. Spira EnteryxÔ, a non-resorbing biocompatible polymer has been shown to facilitate the reduction or discontinuation of proton pump inhibitor (PPI) therapy in patients with chronic gastroesophageal reflux disease (GERD). There appears to be a strong association between GERD and asthma. Up to 45% of asthmatic patients experience at least one episode of symptomatic GERD per week vs. only 10% of non-asthmatic controls. In carefully selected patients with GERD and asthma, medical and surgical treatments have been shown to control GERD and in some cases improve asthma symptoms. The primary aim of this study was to evaluate the safety and efficacy of EnteryxÔ in patients with GERD and asthma. Methods: 52 patients with GERD and asthma were identified in our Asthma Clinic. All patients were taking maintenance PPI therapy. Ten agreed to participate in the study. BravoÔ pH monitoring was performed in all ten. Eight had positive pH testing, defined as a DeMeester Score of O 14.7. Six agreed to participate, one was excluded at the principal investigator’s (PI’s) discretion. All procedures were performed by the PI. EnteryxÔ was injected into the muscular layer of the esophagus under fluoroscopic guidance at or 1 cm below the z-line. 1cc minimum aliquots were placed with each injection. An average of 5.88 cc (range 3.7-7.2) of EnteryxÔ was injected during each session. All patients received sedation with propofol administered by an anesthesiologist or nurse anesthetist. There were no serious adverse events associated with the procedure or the sedation. Mean procedure time was 38 minutes. Standardized health-related quality of life questionnaires (HRQL) for GERD and for asthma along with medication use were measured before implantation and at 1, 2, and 4 weeks after the procedure. Results: At week 4 a statistically significant (p ! 0.05) improvement in HRQL for both GERD and asthma was demonstrated following the EnteryxÔ procedures. A trend toward linear relationship between GERD and asthma HRQL was also noted. Conclusion: Based on the interim analysis of our data the EnteryxÔ procedure appears to be safe and effective in carefully selected patients with GERD and asthma. A statistically significant improvement in both GERD and asthma HRQL scores was demonstrated. Moreover, a trend toward a direct relationship between the improvement in GERD HRQL and asthma HRQL scores was seen. Enrollment continues, we await the 6 and 12-month follow-up data to confirm our initial results.
Volume 61, No. 5 : 2005 GASTROINTESTINAL ENDOSCOPY AB143
S1205 Successful Ablation of Barrett’s Esophagus (BE) with Low Grade Dysplasia (LGD) Using Barrx Bipolar Balloon Device: Preliminary Results of the Ablation of Intestinal Metaplasia with LGD (AIM-LDG) Trial Virender K. Sharma, Roxane McLaughlin, Patrick Dean, Giovanni De Petris, Michele M. Moirano, David E. Fleischer Aims: To evaluate the safety, tolerability & histological clearance of BE with LGD after ablation with the BARRx device. Methods: Prospective trial in patients with 2-6 cm of LGD on 2 EGD in previous 2 yrs, confirmed by 2 pathologists. The BARRx device consists of a bipolar electrode array encircling an esophageal balloon. All patients received 12 J/cm2 at 300W. All patients received lansoprazole 30 mg bid. Tolerability was assessed with 0-100 VAS for peri- and 2-hr post-procedure discomfort, & 14-day symptom diary. EGD at 1, 3, 6 mo with 4-quadrant, q 1 cm biopsies (bx) using maximum capacity forcep; interpreted by a single blinded pathologist. Outcomes were clearance of LGD & BE. Complete Response (CR) Z all bx negative & Partial Response (PR) Z 50-99% bx negative for the outcomes(LGD or IM). Patients with 3 mo CR will proceed to 6 mo EGDCbx. Patients with LGD or BE at 3 mo will be re-treated at 4 mo and undergo 6 mo EGDCbx. Results: Five of 10 planned patients (4 male, mean age 66 yrs, range 54-76, median BE 5 cm) have enrolled. Median procedure time Z 26 min (range 19-37). Ablation time Z 1 sec/3 cm treatment segment. All patients tolerated the procedure well, with low discomfort scores on the exit survey and 14-day diary (median scores !20 out of 100 for all outcomes, except sore throat, median 40/100 resolved by day 6). At 1-mo EGD, all patients had complete healing. EGD was normal in all but 1 patient (mild asymptomatic scarring at proximal edge of ablation zone). One patient had a small focus of Barrett with HGD at 1 and 3-mo that was presumably missed at enrollment (sampling error). He was excluded after 3-month follow-up and offered standard therapy. There were no ‘‘buried glands’’ in 94 follow-up bx. A single treatment resulted in 4 (80%) patients with CR of LGD, & 2 (40%) with CR of BE & 3 (60%) PR of BE (ITT analysis). Conclusion: Ablation of BE with LGD using the BARRx bipolar balloon device creates a circumferential ablation without significant complications or buried glands. The CR of LGD after a single 12 J/cm2 treatment with an intentional overlap is 80%. Complete ablation of BE (without LGD) was achieved in 40% while remaining 60% had only minute residual foci of BE. Patients with persistent disease will undergo a 2nd treatment. The pilot data suggests that the BARRx device can safely and effectively eliminate LGD and BE. Larger trials are planned to evaluate its effectiveness in reducing the progression of LGD to HGD and/or cancer.
S1206 Histological Results of EMR for Esophageal Lesions Diagnosed as High-Grade Intraepithelial Squamous Neoplasia by Endoscopic Biopsy Yuichi Shimizu, Mototsugu Kato, Junji Yamamoto, Yuji Ono, Takehiko Katsurada, Shouko Ono, Yasuaki Mori, Manabu Nakagawa, Souichi Nakagawa, Tomoo Itoh, Masahiro Asaka Background: The ability to detect early squamous neoplasia of the esophagus can be enhanced considerably by iodine staining during endoscopic examination. Histologically, biopsy specimens obtained from the lesion detected in endoscopic screening were often diagnosed as high-grade intraepithelial squamous neoplasia (WHO 1999). However, there are very few reports on the characteristics of such intraepithelial squamous lesions, and a management strategy for such lesions has therefore not been established. In this study, we prospectively performed EMR for esophageal lesions diagnosed as high-grade intraepithelial squamous neoplasia by endoscopic biopsy and investigated histological features of the lesions in totally resected specimens. Patients and Methods: During the period from April 2001 to September 2004, 51 patients were found to have lesions diagnosed as high-grade intraepithelial squamous neoplasia of the esophagus by endoscopic biopsy at Hokkaido University Hospital and associated hospitals. All patients underwent EUS with the use of a high-frequency catheter probe and were confirmed to have no evidence of submucosal tumor invasion. Subsequently, all patients underwent EMR at Hokkaido University Hospital. Results: Histological examination of totally resected specimens revealed that 12 (23.5%) of the 51 patients had tumor invasion of the basement membrane that was confined to the lamina propria mucosae and that 4 (7.8%) of the 51 patients had tumor invasion of the muscularis mucosae. The remaining 35 patients (68.6%) were confirmed to have high-grade intraepithelial squamous neoplasia of the esophagus. The invasive focus all of the 16 lesions of invasive squamous cell carcinoma was surrounded by high-grade intraepithelial squamous neoplasia. Conclusions: Histological results suggested that high-grade intraepithelial squamous neoplasia of the esophagus has characteristics of carcinoma in the pre-invasive stage. EMR, which can be employed both therapeutically and diagnostically, should be performed for esophageal lesions diagnosed by endoscopic biopsy as high-grade intraepithelial squamous neoplasia not only because of its probable malignant potential but also because over 30% of such lesions are actually invasive carcinoma.
www.mosby.com/gie
S1207 The Use of Removable Silicone Stents in Patients with Malignant Esophageal Obstruction: An Initial US Experience Ali Siddiqui, Robert Dudnick, Richard Peterson, Bruce Greenwald, Michel Kahaleh, Paul Yeaton, Oleh Haluszka, David Loren, Thomas Kowalski Background: The aims of this study are to report a multi-institutional experience with the Polyflex self-expanding silicone stent (Ru ¨ sch; Kernen Germany) in patients with malignant stenosis receiving chemoradiation prior to esophagectomy. Methods: A survey was developed to assess procedural success, restoration of oral nutrition, migration, and removal of the Polyflexaˆ stent. The survey was sent to regional institutions and retrospectively completed for all patients in whom the stent was placed for malignant esophageal obstruction. Results: 12 patients underwent Polyflexaˆ stent placement. 10 patients had adenocarcinoma and 2 patients had squamous carcinoma. Stent placement was successful in 11/12 patients (92%). The stricture could not be traversed with the delivery catheter in one patient. Restoration of oral nutrition following stent placement occurred in 10/11 patients (91%). Migration of the stent into the stomach occurred in 5 patients (45%) without occurrence of gastric outlet obstruction; there was no proximal migration. In all cases, migration occurred during neoadjuvant therapy and correlated with restoration of an esophageal lumen adequate for oral nutrition. The mean time from stent placement to migration was 23 days. Stents were successfully removed endoscopically or at the time of esophagectomy. Mean duration from stent placement to removal was 49 days. Conclusions: This early experience suggests that the removable silicone Polyflexaˆ stent is an effective alternative for the management of malignant esophageal stenosis in patients for whom neoadjuvant chemoradiation is planned prior to esophagectomy, and warrants further study.
S1208 Safety and Efficacy of Enteryx for Treatment of GERD in Patients with GERD and Asthma: A Pilot Study Joseph R. DePasquale, Gilbert Simoni, Sohail N. Shaikh, Richard A. Miller, Robert S. Spira EnteryxÔ, a non-resorbing biocompatible polymer has been shown to facilitate the reduction or discontinuation of proton pump inhibitor (PPI) therapy in patients with chronic gastroesophageal reflux disease (GERD). There appears to be a strong association between GERD and asthma. Up to 45% of asthmatic patients experience at least one episode of symptomatic GERD per week vs. only 10% of non-asthmatic controls. In carefully selected patients with GERD and asthma, medical and surgical treatments have been shown to control GERD and in some cases improve asthma symptoms. The primary aim of this study was to evaluate the safety and efficacy of EnteryxÔ in patients with GERD and asthma. Methods: 52 patients with GERD and asthma were identified in our Asthma Clinic. All patients were taking maintenance PPI therapy. Ten agreed to participate in the study. BravoÔ pH monitoring was performed in all ten. Eight had positive pH testing, defined as a DeMeester Score of O 14.7. Six agreed to participate, one was excluded at the principal investigator’s (PI’s) discretion. All procedures were performed by the PI. EnteryxÔ was injected into the muscular layer of the esophagus under fluoroscopic guidance at or 1 cm below the z-line. 1cc minimum aliquots were placed with each injection. An average of 5.88 cc (range 3.7-7.2) of EnteryxÔ was injected during each session. All patients received sedation with propofol administered by an anesthesiologist or nurse anesthetist. There were no serious adverse events associated with the procedure or the sedation. Mean procedure time was 38 minutes. Standardized health-related quality of life questionnaires (HRQL) for GERD and for asthma along with medication use were measured before implantation and at 1, 2, and 4 weeks after the procedure. Results: At week 4 a statistically significant (p ! 0.05) improvement in HRQL for both GERD and asthma was demonstrated following the EnteryxÔ procedures. A trend toward linear relationship between GERD and asthma HRQL was also noted. Conclusion: Based on the interim analysis of our data the EnteryxÔ procedure appears to be safe and effective in carefully selected patients with GERD and asthma. A statistically significant improvement in both GERD and asthma HRQL scores was demonstrated. Moreover, a trend toward a direct relationship between the improvement in GERD HRQL and asthma HRQL scores was seen. Enrollment continues, we await the 6 and 12-month follow-up data to confirm our initial results.
Volume 61, No. 5 : 2005 GASTROINTESTINAL ENDOSCOPY AB143