S1290

Ulcer Healing Process Following Endoscopic Resection of

Esophageal Tumors and Analysis of Factors That Affect the

ProcessToshiro Iizuka, Naohisa Yahagi, Shu HoteyaObjective: Endoscopic submucosal dissection (ESD) is conducted in an increasingnumber of patients with esophageal tumors as its popularity increases andsurgeons’ techniques improve. However, the esophageal ulcer healing processfollowing ESD has not been analyzed, and whether esophageal ulcers followingESD show a healing process similar to that seen following gastric ESD remainsunknown. We conducted a retrospective study of the ulcer healing processfollowing ESD and found that the healing of esophageal ulcers following ESD showstwo different patterns. Factors that affect the healing process were analyzed.Subjects and methods: Included in the present study were 75 patients whounderwent ESD for esophageal tumors between April 2005 and September 2006.Of the 82 lesions, 49 were analyzed after excluding 33 which could not be followedup due to additional resection or stenosis following ESD. Endoscopy wasconducted 4-8 weeks after ESD to observe the ulcer healing status. Two differenthealing patterns were noted, so clinical factors (such as the diameter of resectedspecimens, duration of fasting after ESD, time needed for ESD, and past history)that affect the healing process were evaluated. Results: Forty-three men and sixwomen, aged 64.5 on the average, were included in the study. Post-ESD ulcersbecame ulcer scars in 83% of cases 4 weeks after ESD and 100% of cases 6 weeksafter ESD and onward. Two healing patters were noted: converging type, whichshows tightening of the mucosa as if it was pulled toward the ulcer center, andelevation type, which shows the regenerative epithelium that built up from theulcer bottom without showing mucosal tightening. The converging type was notedin 39 cases and the elevation type in 10. The maximum diameter of resectedspecimens was 34.6 mm and 48 mm, respectively, for the converging type and theelevation type; duration of fasting after ESD 1.8 and 3.3 days; and time needed forESD 71 and 101 min. All differences were statistically significant (p Z 0.02, p Z0.0078, p Z 0.01). Conclusion: The ulcer healing process following ESD conductedfor esophageal tumors showed two different patterns: converging type andelevation type. The diameter of resected specimens and duration of fasting afterESD appeared to affect the healing process. Stenosis is one of the majorcomplications following esophageal ESD. However, our findings suggest that post-ESD stenosis can be prevented by inducing the elevation-type healing by fastingpatients for 3 days or more following ESD even if the dissection diameter is large.

S1291

Radiofrequency Ablation of Barrett’s Esophagus Containing

High-Grade DysplasiaJoep J. Gondrie, Femke Peters, Wouter L. Curvers, Carine Sondermeijer,Fiebo J. Ten Kate, Paul Fockens, Jacques J. BergmanBackground: Circumferential balloon-based ablation of non-dysplastic Barrett’sesophagus (BE) has been proven by others as safe and effective. This study assessedthe efficacy and safety of ablation for BE with high-grade dysplasia (HGD) inpatients with and without prior endoscopic resection (ER). Methods: Eligiblepatients demonstrated BE with HGD on at least 2 prior EGDs. Visible abnormalitieswere resected with ER prior to ablation. Persistence of dysplasia was confirmed withbiopsy after ER. Patients received esomeprazole 40 mg BID during study. A balloon-based electrode (HALO360 System) was used for primary circumferential ablation(CA) and an endoscope-mounted electrode (HALO90 System) for secondary focalablation (FA) of residual BE. Both systems (BARRX Medical, Sunnyvale, CA) use anelectrode array that delivers a short burst of high power RF energy (40 W/cm2) ata preset energy density (12 J/cm2). After primary CA, EGD was performed at 2 mointervals with secondary ablation of residual BE using CA or FA, depending onextent of BE. Two mos after the last ablation, EGD with Lugol’s and large cup biopsy(4Q/q 1 cm) was performed. Histopathology was reviewed by a single pathologist.Primary endpoint: complete response dysplasia (CR-D), absence of dysplasia in allbiopsies. Secondary endpoints: adverse events (AE); visible BE regression;complete response intestinal metaplasia (CR-IM), absence of IM in all biopsies.Results: Twenty-three pts (17 men, median age 66 yrs, IQR 55-78) were treated(median BE length 7 cm, IQR 4-10). ER was performed in 13 patients: mucosalcarcinoma (n Z 4), HGD (n Z 6) and LGD (n Z 3). Worst pathological grade of BEafter ER and prior to RFA was LGD (n Z 3) and HGD (n Z 20). Patients underwenta mean of 1.5 CA and 2.6 FA sessions. CR-D was achieved in 22/23 patients (96%)and CR-IM in 21/23 patients (92%). Patients with residual BE (n Z 2) have onlysmall islands remaining (median BE regression: 99%). There were 3 AE’s. Fever/chest pain (n Z 2) after CA, resolved with narcotics. An ER-related stenosis (n Z 1),resolved after 1 dilation. There were no thermally-mediated strictures. Aftera median additional follow-up of 6 mos and 2.1 endoscopies, no patient with CR-Dhas shown recurrence of dysplasia and no patient with CR-IM has shown recurrenceof IM. None of the 521 biopsies of neosquamous mucosa contained subsquamousBE (‘‘buried Barrett’s’’). Conclusions: Radiofrequency ablation of BE containingHGD is a safe and effective treatment, with a CR-D and CR-IM of 96% and 92%,respectively. Circumferential and focal ablation using the HALO devices can besafety performed after prior ER for endoscopically visible abnormalities.

S1292

Long-Term (2.5 Year) Follow-Up of the AIM-II Trial for Ablation

of Barrett Esophagus: Results After Primary Circumferential

Ablation Followed By Secondary Focal AblationDavid E. Fleischer, Bergein F. Overholt, Virender K. Sharma,Alvaro Reymunde, Michael B. Kimmey, RAM Chuttani, Kenneth Chang,Charles J. Lightdale, Nilda Santiago, Douglas K. Pleskow, Patrick J. Dean,Kenneth K. WangAims: Any endoscopic method for ablation of Barrett esophagus (BE) mustdemonstrate high efficacy and long-term benefit. We assessed the long-term(2.5 year) follow-up results of ablation of non-dysplastic (BE) using primarycircumferential ablation (CA) followed by secondary focal ablation (FA). Methods:This study was conducted at 8 U.S. centers from May 2004 to Dec 2006. The CAdevice (HALO360 System, BARRX Medical, Sunnyvale, CA) is a balloon-based ablationcatheter and delivers a programmed amount of energy circumferentially to BE. TheFA device (HALO90 System) is an endoscope-mounted electrode. In previousreports, these devices ablate to the muscularis mucosae without stricture formation.The AIM-II Trial included pts with BE (2-6 cm). CA was performed (10 J/cm2 delivered2� per session) and repeated at 4 months (if needed.) The trial was extended after 1year follow-up to include FA for any visible BE (up to 2 sessions). Patients underwentEGD with 4Q/q2 cm bx plus directed bx at 1, 3, 6, 12, 30 mo. All receivedesomeprazole 40 bid 1 month post-ablation and 40 qd thereafter. Symptoms afterCA and FA sessions (chest, throat, abdominal pain; odynophagia; dysphagia) werequantified using a 14-day diary (visual analog scale, VAS, 0-100). Primary outcomewas histological complete response (CR), defined as all bx negative for IM at 12 and30 mos. Pathology was read centrally (GI pathologist) in a blinded manner. T-testwas used to compare procedure time, sedation requirement, and diary scoresbetween CA and FA. Results: 70 pts (52 men, mean age 55.7 yrs, range 26-79, meanBE 3.2 cm) were enrolled. Median procedure time for CA was 28 min (IQR 24-33).Median diary scores !20/100 for each symptom on day 1, and returned to 0/100 byday 5. At 12 mo (n Z 69; mean 1.5 sessions), CR for BE was achieved in 70% of pts.There were no strictures.62 patients (89%) participated in the trial extension.Median procedure time for FA was 16 min (IQR 10-21), significantly shorter thanCA (p ! 0.001). Median diary scores !20/100 for each symptoms day 1, and allreturned to 0/100 by day 4, comparable to CA (p O 0.05). At 30 mos (n Z 60, mean1.7 sessions), CR for BE was achieved in 83% of pts (ITT 81%). Additional FA andfollow-up biopsies pending. There were no strictures. Conclusion: A sequentialregimen of circumferential and focal ablation of BE results in complete eliminationof BE in 83% of patients at 2.5 year follow-up (with additional ablation and follow-uppending in some pts). FA improves on the complete response achieved withCA alone, and is well tolerated by patients (shorter procedure times, less proceduremedication, and comparable symptom scores vis-a-vis CA.)

Abstracts

www.giejournal.org V

S1293

Endoscopic Resection of Early Esophageal Adenocarcinoma and

High Grade Dysplasia in Elderly Patients with Barrett Esophagus

Using a Multi-Band Endoscopic Resection DeviceAnanya Das, Giovanni De Petris, Christopher D. Wells,Cuong C. Nguyen, Hack J. Kim, David E. Fleischer, Virender K. SharmaBackground: Endoscopic Resection (ER) is an emerging treatment modality formanagement of early stage esopahgeal adenocarcinoma (EAC) and nodular high-grade dysplasia (HGD) in the setting of Barrett Esophagus (BE). Aim: To report ourexperience of performing ER for nodular HGD and early stage EAC using the ‘ligateand cut’ technique with a multi-band ER device (DuetTM, Cook Medical) in a groupof elderly patients. Methods: Starting September 2005, consecutive patients withnodular HGD and early stage EAC, who were not operative candidates, and whounderwent ER with a multi-band ER device were identified. Information on patientdemographics, prior ablative therapy for BE, findings on endoscopic ultrasound,final histopathology, complications, and follow-up was extracted. Results: A total of20 patients (18 men; mean age 73 years) with BE underwent 27 treatment sessionswith ER for focal nodular lesions; 14 of these were early stage EAC. Twelve (60%) ofthese patients had undergone prior ablative therapy with either photodynamictherapy (PDT) or radio-frequency ablation for BE with flat HGD. In patients withEAC, the degree of submucosal invasion was correctly predicted by EUS in all 4patients without, and in only 6 of 10 patients with prior ablative therapy for BE(100% vs. 60%, p ! 0.05). In 18 patients (90%) complete ER of the neoplastic lesionwas achieved after 1-2 ER sessions; no major complications were encountered evenin those patients who had been treated with prior ablative therapy. Minor bleedingoccurred in 3 patients and was successfully treated endoscopically. All procedureswere done in an ambulatory endoscopy unit as an outpatient; only 2 patientsrequired brief inpatient observation. Those patients with incomplete ER orpresence of submucosal invasion by cancer in the resected specimens were treatedby additional PDT. There was no recurrence of cancer over a median follow upperiod of 8.5 (range, 4-13) months. Conclusions: ER with a multi-band ER device issafe and effective intervention in elderly patients with nodular HGD and early stageEAC. In poor surgical risk patients or those unwilling to undergo surgery, ER with orwithout endoscopic ablative therapy is an effective alternative to surgery for thetreatment for HGD and early stage EAC. Prior ablative therapy for BE may, however,reduce the accuracy of EUS staging in detecting submucosal invasion.

olume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB135