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732 A Multicenter Randomized Trial Comparing Two Ablation Regimens for Focal Radiofrequency Ablation of Barrett's Mucosa Using the HALO90 System
Barrett's in 1 patient. There were no adverse events and no perforations. No pain was present in 78% of patients the day of the procedure and in 89% of patients 3 days after the procedure. The mean scores for pain on the day of and at 3 days after the procedure were 0.89 and 0.2 respectively. Swallowing difficulty was present in 11% on the day of and in 22% at 3 days after the procedure. The mean scores for swallowing difficulty on the day of and at 3 days after the procedure were 0.3 and 0.6 respectively. Details of the histology are shown (Table). Conclusions: Ablation with a novel cryoballoon device for 10-14 seconds results in substantial mucosal injury with minimal pain or impaired swallowing. Depth of necrosis was maximal at day 4 and was typically into the superficial muscularis propria. By 7 days the injury was resolving, a finding similar to previous work with this device in animals. Major advantages of this device include the ability to standardize the ablation along with the ease of use and quickness of the procedure. Future studies will assess the risk of stricture and efficacy for Barrett's ablation with this device.
*Key: 0=no necrosis; 1=necrosis only involving mucosa including or superficial to muscularis mucosa; 2=necrosis into but not through submucosa; 3=necrosis into superficial muscularis propria; 4=necrosis involving full-thickness of muscularis propria, no perforation 732
SSAT Abstracts
A Multicenter Randomized Trial Comparing Two Ablation Regimens for Focal Radiofrequency Ablation of Barrett's Mucosa Using the HALO90 System Frederike G. van Vilsteren, Lorenza Alvarez Herrero, Roos E. Pouw, Kai Yi N. Phoa, Carine Sondermeijer, Mike Visser, Fiebo J. ten Kate, Mark I. van Berge Henegouwen, Bas L. Weusten, Erik J. Schoon, Jacques J. Bergman BACKGROUND: The currently recommended regimen for endoscopic focal radiofrequency ablation (RFA) of Barrett's esophagus (BE) comprises two applications of energy, cleaning of the device and ablation zone, and two additional applications of energy. A simplified regimen may be of clinical utility, if it were faster, easier and equally safe and effective. AIM: To compare the efficacy of two focal RFA regimens. METHODS: In 3 centers, consecutive patients scheduled for endoscopic focal RFA of BE were enrolled having flat type BE with at least 2 BE islands or mosaic groups of islands (each less than the surface area of two HALO90 ablation catheters). Targeted BE areas were paired according to similar size: one of each area was randomized to the 'standard' regimen (2x15J/cm2-clean-2x15J/cm2) or 'simplified' regimen (3x15J/cm2-no clean), allocating the second area automatically to the other regimen. The % surface area of each target was scored at 2 months by the endoscopist, who was blinded to patient and regimen type. Patients underwent RFA every 2 months until complete histological response of each targeted BE area was achieved for neoplasia and intestinal metaplasia (CR-N; CR-IM). Primary outcome: CR-IM for each target at 2 months (non-inferiority defined as <20% difference in the paired proportions, sample size calculated at 46 pairs). Secondary outcome: surface regression (%) for each target at 2 months. RESULTS: Forty-five equivalent pairs of target BE areas were randomized by Dec '11, in 40 patients (29 male, age 64±12 years, BE C4M7). The proportion of targets showing CR-IM at 2 months after focal-RFA was 30/45 (66.7%) for standard and 33/45 (73.3%) for simplified: A difference of 6.7% (95%CI -12.2 to +25.6). The median surface regression for each target at 2 months was 100% in both groups, whereas for not completely eradicated areas this was 77.5% (IQR50-90)% for standard and 75% (IQR50-90) for simplified (p= 1.0). No complications occurred. By Dec '11, CR-IM and CR-N was achieved in 91.1% (31/ 34) and 100% of patients, whereas 7 patients are under treatment. CONCLUSIONS: The results of this multicenter randomized trial suggest that a simplified 3x15J/cm2 focal ablation regimen is not inferior to the standard regimen. Therefore, the simplified regimen may be recommended for residual Barrett's islands.
Impact of pelvic radiation on pouch outcome: Kaplan-Meier survival analysis with log-rank test. (A) All IBD-CRC patients, n=56; with pelvic radiation, n=9; without pelvic radiation, n=47. (B) IBD associated rectal cancer patients, n=24; with pelvic radiation, n=7; without pelvic radiation, n=17. 731 Initial Human Experience With a Novel Through-the-Scope Cryoballoon Device for Mucosal Ablation Steven R. DeMeester, Omar Awais, Jacques J. Bergman, Kimberly S. Grant, Blair A. Jobe, Stefan Niebisch, Jeffrey H. Peters, Dirk Schölvinck, Mark I. van Berge Henegouwen, Bas L. Weusten
733
Introduction: Ablation of Barrett's with high-grade dysplasia has become standard. The most common ablation technique uses radiofrequency energy, but a drawback is the requirement that the devices be used either separate from or attached to the outside of an endoscope. An alternative is cryoablation, but current cryotherapy devices are cumbersome, require gastric venting, and ablation depth is difficult to standardize. A device that goes down the working channel of an endoscope that delivers a uniform and reproducible ablation would potentially be safer and more user-friendly. The aim of this study was to assess depth of injury related to time of ablation using a novel through-the-scope balloon-based cryotherapy device. Methods: Patients with esophageal cancer were enrolled in a multi-center prospective trial evaluating a novel cryoballoon ablation device prior to esophagectomy. The device is a through-the-scope, highly compliant balloon catheter that is inflated and cooled by an inert refrigerant delivered from a handheld unit. The balloon automatically sizes to the esophageal lumen. One to two ablations were performed in separate areas in each patient in mucosa proximal to the tumor. After resection, the ablation sites were removed as a fullthickness block and examined histologically by a central study pathologist. Symptoms were assessed prior to ablation, on the day of and 3 days after the procedure using a standardized questionnaire with a 10-point scale. Results: Twenty-one ablations were performed in 13 patients for 6, 10, 12 or 14 seconds, and the esophagus was removed 0, 4 or 7 days after the procedure. The ablation was in squamous mucosa in 12 patients and in dysplastic
SSAT Abstracts
Indirect Costs of Mortality and Morbidity and Direct Economic Costs in a Randomized Controlled Trial of Emergency Therapy of Bleeding Esophageal Varices in Cirrhosis Marshall J. Orloff, Jon I. Isenberg, Florin Vaida, Henry O. Wheeler, Kevin Haynes, Horacio Jinich-Brook, Roderick C. Rapier, Robert J. Hye, Wendy Max OBJECTIVE(S): Economic cost is an important measure of effectiveness of treatment of cirrhosis and bleeding esophageal varices (BEV). There have been no reports of costs of any form of emergency treatment of BEV. We examined costs of care in a randomized controlled trial (RCT) that compared endoscopic sclerotherapy (EST) (n=106) to emergency portacaval shunt (EPCS) (n=105), in unselected, consecutive patients (“all comers”). METHODS: Diagnostic workup and treatment were undertaken within 8 hours. Crossover rescue treatment was applied when primary therapy failed according to clearly defined criteria. 96% of patients underwent 10+ years follow-up, or until death. Indirect costs measured by the economic value of premature death (mortality) and by days lost from work (morbidity) were determined from tables of life expectancy, average earnings at each age, labor force participation rates, and an integrating computer program. Direct costs were determined from complete data on all inpatient and outpatient charges by hospitals and physicians for 10 years. RESULTS: Indirect costs were significantly lower following EPCS than after EST (p<0.001) based on
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*Key: 0=no necrosis; 1=necrosis only involving mucosa including or superficial to muscularis mucosa; 2=necrosis into but not through submucosa; 3=necrosis into superficial muscularis propria; 4=necrosis involving full-thickness of muscularis propria, no perforation 732
SSAT Abstracts
A Multicenter Randomized Trial Comparing Two Ablation Regimens for Focal Radiofrequency Ablation of Barrett's Mucosa Using the HALO90 System Frederike G. van Vilsteren, Lorenza Alvarez Herrero, Roos E. Pouw, Kai Yi N. Phoa, Carine Sondermeijer, Mike Visser, Fiebo J. ten Kate, Mark I. van Berge Henegouwen, Bas L. Weusten, Erik J. Schoon, Jacques J. Bergman BACKGROUND: The currently recommended regimen for endoscopic focal radiofrequency ablation (RFA) of Barrett's esophagus (BE) comprises two applications of energy, cleaning of the device and ablation zone, and two additional applications of energy. A simplified regimen may be of clinical utility, if it were faster, easier and equally safe and effective. AIM: To compare the efficacy of two focal RFA regimens. METHODS: In 3 centers, consecutive patients scheduled for endoscopic focal RFA of BE were enrolled having flat type BE with at least 2 BE islands or mosaic groups of islands (each less than the surface area of two HALO90 ablation catheters). Targeted BE areas were paired according to similar size: one of each area was randomized to the 'standard' regimen (2x15J/cm2-clean-2x15J/cm2) or 'simplified' regimen (3x15J/cm2-no clean), allocating the second area automatically to the other regimen. The % surface area of each target was scored at 2 months by the endoscopist, who was blinded to patient and regimen type. Patients underwent RFA every 2 months until complete histological response of each targeted BE area was achieved for neoplasia and intestinal metaplasia (CR-N; CR-IM). Primary outcome: CR-IM for each target at 2 months (non-inferiority defined as <20% difference in the paired proportions, sample size calculated at 46 pairs). Secondary outcome: surface regression (%) for each target at 2 months. RESULTS: Forty-five equivalent pairs of target BE areas were randomized by Dec '11, in 40 patients (29 male, age 64±12 years, BE C4M7). The proportion of targets showing CR-IM at 2 months after focal-RFA was 30/45 (66.7%) for standard and 33/45 (73.3%) for simplified: A difference of 6.7% (95%CI -12.2 to +25.6). The median surface regression for each target at 2 months was 100% in both groups, whereas for not completely eradicated areas this was 77.5% (IQR50-90)% for standard and 75% (IQR50-90) for simplified (p= 1.0). No complications occurred. By Dec '11, CR-IM and CR-N was achieved in 91.1% (31/ 34) and 100% of patients, whereas 7 patients are under treatment. CONCLUSIONS: The results of this multicenter randomized trial suggest that a simplified 3x15J/cm2 focal ablation regimen is not inferior to the standard regimen. Therefore, the simplified regimen may be recommended for residual Barrett's islands.
Impact of pelvic radiation on pouch outcome: Kaplan-Meier survival analysis with log-rank test. (A) All IBD-CRC patients, n=56; with pelvic radiation, n=9; without pelvic radiation, n=47. (B) IBD associated rectal cancer patients, n=24; with pelvic radiation, n=7; without pelvic radiation, n=17. 731 Initial Human Experience With a Novel Through-the-Scope Cryoballoon Device for Mucosal Ablation Steven R. DeMeester, Omar Awais, Jacques J. Bergman, Kimberly S. Grant, Blair A. Jobe, Stefan Niebisch, Jeffrey H. Peters, Dirk Schölvinck, Mark I. van Berge Henegouwen, Bas L. Weusten
733
Introduction: Ablation of Barrett's with high-grade dysplasia has become standard. The most common ablation technique uses radiofrequency energy, but a drawback is the requirement that the devices be used either separate from or attached to the outside of an endoscope. An alternative is cryoablation, but current cryotherapy devices are cumbersome, require gastric venting, and ablation depth is difficult to standardize. A device that goes down the working channel of an endoscope that delivers a uniform and reproducible ablation would potentially be safer and more user-friendly. The aim of this study was to assess depth of injury related to time of ablation using a novel through-the-scope balloon-based cryotherapy device. Methods: Patients with esophageal cancer were enrolled in a multi-center prospective trial evaluating a novel cryoballoon ablation device prior to esophagectomy. The device is a through-the-scope, highly compliant balloon catheter that is inflated and cooled by an inert refrigerant delivered from a handheld unit. The balloon automatically sizes to the esophageal lumen. One to two ablations were performed in separate areas in each patient in mucosa proximal to the tumor. After resection, the ablation sites were removed as a fullthickness block and examined histologically by a central study pathologist. Symptoms were assessed prior to ablation, on the day of and 3 days after the procedure using a standardized questionnaire with a 10-point scale. Results: Twenty-one ablations were performed in 13 patients for 6, 10, 12 or 14 seconds, and the esophagus was removed 0, 4 or 7 days after the procedure. The ablation was in squamous mucosa in 12 patients and in dysplastic
SSAT Abstracts
Indirect Costs of Mortality and Morbidity and Direct Economic Costs in a Randomized Controlled Trial of Emergency Therapy of Bleeding Esophageal Varices in Cirrhosis Marshall J. Orloff, Jon I. Isenberg, Florin Vaida, Henry O. Wheeler, Kevin Haynes, Horacio Jinich-Brook, Roderick C. Rapier, Robert J. Hye, Wendy Max OBJECTIVE(S): Economic cost is an important measure of effectiveness of treatment of cirrhosis and bleeding esophageal varices (BEV). There have been no reports of costs of any form of emergency treatment of BEV. We examined costs of care in a randomized controlled trial (RCT) that compared endoscopic sclerotherapy (EST) (n=106) to emergency portacaval shunt (EPCS) (n=105), in unselected, consecutive patients (“all comers”). METHODS: Diagnostic workup and treatment were undertaken within 8 hours. Crossover rescue treatment was applied when primary therapy failed according to clearly defined criteria. 96% of patients underwent 10+ years follow-up, or until death. Indirect costs measured by the economic value of premature death (mortality) and by days lost from work (morbidity) were determined from tables of life expectancy, average earnings at each age, labor force participation rates, and an integrating computer program. Direct costs were determined from complete data on all inpatient and outpatient charges by hospitals and physicians for 10 years. RESULTS: Indirect costs were significantly lower following EPCS than after EST (p<0.001) based on
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