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Circumferential Balloon-Based Radiofrequency Ablation of Barrett's Esophagus Using the HALO 360 Ablation System Preserves the Inner Diameter of the Esophagus and Prevents Subsequent Narrowing and Compliance Reduction
Abstracts
S1544 Endoscopic Diagnosis of Depth and Extension of Cancer Invasion of Superficial Barrett’s Adenocarcinoma Iizuka Toshiro, Yahagi Naohisa, Hoteya Shu, Yamamoto Takashi Objective: There are few cases of superficial Barrett’s adenocarcinoma, even though Barrett’s adenocarcinoma is increasing in these days. But there are some cases to indicate endoscopic treatment in advanced of early detection. In an endoscopic treatment it is very important to make a diagnosis of depth and extension of the cancer precisely, because these have a close relation to both recurrence and lymph node metastasis. So we investigated to the accuracy of depth and extension of our cases retrospectively. Subjects and Methods: In this study 13 patients who were diagnosed of superficial Barrtte’s adenocarcinoma between January, 1998 and September, 2005 were included. The accuracy of depth and extension of cancer was investigated. For diagnosing depth of invasion by EUS, a small soft balloon with an effective length of 1 cm was used, as well as a 30 MHz probe from Olympus. For diagnosing extension of invasion, both ordinary endoscopy and spraying indigocarmine were used. Results: Clinicopathological features of all 13 lesions show as follows: there were 5 lesions of m carcinoma and 8 of sm carcinoma histologically, 9 lesions were macroscopically classified as an elevated type and 4 as a depressed type. As a treatment 5 lesions underwent surgical resection, 4 endoscopic resection, and 4 surgical resection after endoscopic treatment. The cancer growth under normal squamous epithelium was detected in 8 cases (62%), this extension size was 5.4 mm in average, and the cancer growth under normal columnar epithelium was detected in 4 cases (31%). The accurate diagnosis rate of depth of invasion by EUS was 77%; diagnosis rate for mucosal carcinoma and submucosal carcinoma was 67 and 86%, respectively. The correct diagnosis rate of lateral margin was 75%, but it was impossible to diagnose lateral margin in 2 cases because of cancer growth under normal squamous epithelium. Discussion: In order to cure superficial Barrett’s adenocarcinoma by endoscopic treatment, it would be a task to make a correct diagnosis of depth and extension of cancer invasion.
Caucasians than any other racial or ethnic group studied. Our finding of a 1.1% prevalence of BE among Hispanic patients undergoing EGD is significantly lower than previously reported and is more similar to the rate among African-Americans. These findings add to our knowledge of BE epidemiology. Prevalence of Barrett’s Esophagus Among Racial/Ethinic Groups Racial/ Ethnic Group Caucasian AfricanAmerican Hispanic/Latino Asian Other
# New # All % with EGDs BE BE (95% CI) Cases
p value)
% with # EGDs for GERD/ BE dyspepsia (95% CI)
p value)
82 18
2943 2.8% (2.3-3.5) 2498 0.7% (0.5-1.1)
!0.001
647 511
12.7% (10.3-15.5) 3.5% (2.2-5.5)
!0.001
19 2 4
1694 1.1% (0.7-1.7) !0.001 363 0.6% (0.2-2.0) 0.007 479 0.8% (0.3-2.1) 0.007
387 72 98
4.9% (3.2-7.5) 2.8% (0.8-9.6) 4.1% (1.6-10.0)
!0.001 0.01 0.01
)P values based on two-tailed Fisher’s Exact test comparing group to Caucasians
S1546 Circumferential Balloon-Based Radiofrequency Ablation of Barrett’s Esophagus in Patients with Low-Grade Dysplasia Or High-Grade Dysplasia with and Without a Prior Endoscopic Resection Using the HALO360 Ablation System Jacques J. Bergman, Carine Sondermeijer, Femke P. Peters, Fiebo J. Ten Kate, Paul Fockens
S1545 The Prevalence of Barrett’s Esophagus Among Hispanics Is Lower Than That of Caucasians Brian C. Jacobson, Curtis T. Barry, Zhao Liu Background: While Barrett’s esophagus (BE) is more common among Caucasians than African-Americans, knowledge about its prevalence among Hispanics is extremely limited. We sought to determine the prevalence of BE among various racial and ethnic groups undergoing EGD at our institution. Methods: We merged administrative data containing self-reported racial identities with our endoscopy database, retrieving for analysis all adult patients who underwent non-PEG-related EGD between 1/1/00 and 6/30/05. We excluded from analysis those without race information. We then identified those with BE reported at endoscopy and reviewed their pathology findings. To determine the prevalence of BE, we excluded EGDs done for BE surveillance. We defined BE as the presence of specialized intestinal metaplasia (SIM) in esophageal biopsies and determined its prevalence among patients who underwent EGD for 1) all indications and 2) heartburn/dyspepsia. When the segment of columnar mucosa visualized was described only as an irregular z-line, the length assigned was 1 cm. Results: There were 8,206 individuals who underwent EGD during the period studied. There was no race information available for 229, leaving 7,977 as the baseline study population. There were 393 EGDs with BE reported, but BE was a new finding in only 325 (4.1%). Histology demonstrated SIM in 125 (1.6%), and this constituted the group used for prevalence data. The table shows the numbers of each racial group that underwent EGD, the % with BE, and p values. The median length of BE was 2 cm (IQR 1-4) and there was no significant difference in median length between Caucasians and the other groups. Conclusions: The prevalence of BE is significantly higher among
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Background: Circumferential balloon-based radiofrequency (RF) energy ablation of Barrett’s esophagus (BE) has proved safe and effective for non-dysplastic BE. This study assesses the efficacy and safety of RF ablation in patients with BE containing LGD or HGD C/ÿ prior endoscopic resection (ER). Methods: Eligibility: BE 2-7 cm with LGD or HGD from R2 EGD sessions, visible abnormalities removed by ER prior to ablation, and esomeprazole 40 mg BID during study. The HALO360 ˆRRX Medical, Sunnyvale, CA) consists of a balloon-based Ablation System (BA electrode array which delivers a short burst of high power (300 W, !1 sec) RF energy to the BE tissue. Energy density (12 J/cm2) and balloon pressure are controlled, enabling uniform ablation depth. At baseline and 10 weeks, ablation was performed from the proximal margin of BE to the gastric folds. Post-ablation symptoms (odynophagia; dysphagia; chest, throat and abdominal pain) were assessed by 14-day visual analog scale (0-100 mm, VAS) survey. At 4 months, EGD, Lugol’s staining and biopsies (4Q/1 cm) were performed and histology was reviewed by an expert pathologist. Primary endpoint was complete response (CR) defined as absence of dysplasia at 4 months. Secondary endpoints: safety, VAS scores, and surface area regression of BE. Results: 11 pts (8 men, median age 60 yrs, IQR 55-67) were treated (median BE length 5 cm, IQR 3-7). Six pts had prior ER with early carcinoma (n Z 2), HGD (n Z 1) and LGD (n Z 3) in the resection specimens. Baseline diagnosis after ER and prior to ablation was LGD (n Z 1) and HGD (n Z 10). After 2 sessions, 10/11 patients are in CR for dysplasia (91% CR rate). The patient with persistent dysplasia, went from HGD to LGD and has only small residual islands of Barrett’s mucosa left. All procedures were performed on a outpatients’ basis and there were no serious adverse events, i.e., no strictures or buried glands. The median day #1 VAS was 27/100 (IQR 0-53) for chest pain, returning to 0/100 by day #5. The median day #1 VAS for other symptoms was 0/100 (max IQR 0-23 for odynophagia). Median BE regression was 90% (IQR 80-95) at 10 weeks, and 99% (IQR 95-99) at 4 months. Conclusions: Circumferential RF ablation using the HALO360 Ablation System appears to be a safe and effective treatment for BE containing LGD or HGD, with a 91% CR rate for dysplasia and minimal side effects. Patients now have very limited residual BE (mostly non-dysplastic) and are candidates for completion of treatment with a focal ablation device utilizing the same electrode array technology.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB137
S1544 Endoscopic Diagnosis of Depth and Extension of Cancer Invasion of Superficial Barrett’s Adenocarcinoma Iizuka Toshiro, Yahagi Naohisa, Hoteya Shu, Yamamoto Takashi Objective: There are few cases of superficial Barrett’s adenocarcinoma, even though Barrett’s adenocarcinoma is increasing in these days. But there are some cases to indicate endoscopic treatment in advanced of early detection. In an endoscopic treatment it is very important to make a diagnosis of depth and extension of the cancer precisely, because these have a close relation to both recurrence and lymph node metastasis. So we investigated to the accuracy of depth and extension of our cases retrospectively. Subjects and Methods: In this study 13 patients who were diagnosed of superficial Barrtte’s adenocarcinoma between January, 1998 and September, 2005 were included. The accuracy of depth and extension of cancer was investigated. For diagnosing depth of invasion by EUS, a small soft balloon with an effective length of 1 cm was used, as well as a 30 MHz probe from Olympus. For diagnosing extension of invasion, both ordinary endoscopy and spraying indigocarmine were used. Results: Clinicopathological features of all 13 lesions show as follows: there were 5 lesions of m carcinoma and 8 of sm carcinoma histologically, 9 lesions were macroscopically classified as an elevated type and 4 as a depressed type. As a treatment 5 lesions underwent surgical resection, 4 endoscopic resection, and 4 surgical resection after endoscopic treatment. The cancer growth under normal squamous epithelium was detected in 8 cases (62%), this extension size was 5.4 mm in average, and the cancer growth under normal columnar epithelium was detected in 4 cases (31%). The accurate diagnosis rate of depth of invasion by EUS was 77%; diagnosis rate for mucosal carcinoma and submucosal carcinoma was 67 and 86%, respectively. The correct diagnosis rate of lateral margin was 75%, but it was impossible to diagnose lateral margin in 2 cases because of cancer growth under normal squamous epithelium. Discussion: In order to cure superficial Barrett’s adenocarcinoma by endoscopic treatment, it would be a task to make a correct diagnosis of depth and extension of cancer invasion.
Caucasians than any other racial or ethnic group studied. Our finding of a 1.1% prevalence of BE among Hispanic patients undergoing EGD is significantly lower than previously reported and is more similar to the rate among African-Americans. These findings add to our knowledge of BE epidemiology. Prevalence of Barrett’s Esophagus Among Racial/Ethinic Groups Racial/ Ethnic Group Caucasian AfricanAmerican Hispanic/Latino Asian Other
# New # All % with EGDs BE BE (95% CI) Cases
p value)
% with # EGDs for GERD/ BE dyspepsia (95% CI)
p value)
82 18
2943 2.8% (2.3-3.5) 2498 0.7% (0.5-1.1)
!0.001
647 511
12.7% (10.3-15.5) 3.5% (2.2-5.5)
!0.001
19 2 4
1694 1.1% (0.7-1.7) !0.001 363 0.6% (0.2-2.0) 0.007 479 0.8% (0.3-2.1) 0.007
387 72 98
4.9% (3.2-7.5) 2.8% (0.8-9.6) 4.1% (1.6-10.0)
!0.001 0.01 0.01
)P values based on two-tailed Fisher’s Exact test comparing group to Caucasians
S1546 Circumferential Balloon-Based Radiofrequency Ablation of Barrett’s Esophagus in Patients with Low-Grade Dysplasia Or High-Grade Dysplasia with and Without a Prior Endoscopic Resection Using the HALO360 Ablation System Jacques J. Bergman, Carine Sondermeijer, Femke P. Peters, Fiebo J. Ten Kate, Paul Fockens
S1545 The Prevalence of Barrett’s Esophagus Among Hispanics Is Lower Than That of Caucasians Brian C. Jacobson, Curtis T. Barry, Zhao Liu Background: While Barrett’s esophagus (BE) is more common among Caucasians than African-Americans, knowledge about its prevalence among Hispanics is extremely limited. We sought to determine the prevalence of BE among various racial and ethnic groups undergoing EGD at our institution. Methods: We merged administrative data containing self-reported racial identities with our endoscopy database, retrieving for analysis all adult patients who underwent non-PEG-related EGD between 1/1/00 and 6/30/05. We excluded from analysis those without race information. We then identified those with BE reported at endoscopy and reviewed their pathology findings. To determine the prevalence of BE, we excluded EGDs done for BE surveillance. We defined BE as the presence of specialized intestinal metaplasia (SIM) in esophageal biopsies and determined its prevalence among patients who underwent EGD for 1) all indications and 2) heartburn/dyspepsia. When the segment of columnar mucosa visualized was described only as an irregular z-line, the length assigned was 1 cm. Results: There were 8,206 individuals who underwent EGD during the period studied. There was no race information available for 229, leaving 7,977 as the baseline study population. There were 393 EGDs with BE reported, but BE was a new finding in only 325 (4.1%). Histology demonstrated SIM in 125 (1.6%), and this constituted the group used for prevalence data. The table shows the numbers of each racial group that underwent EGD, the % with BE, and p values. The median length of BE was 2 cm (IQR 1-4) and there was no significant difference in median length between Caucasians and the other groups. Conclusions: The prevalence of BE is significantly higher among
www.giejournal.org
Background: Circumferential balloon-based radiofrequency (RF) energy ablation of Barrett’s esophagus (BE) has proved safe and effective for non-dysplastic BE. This study assesses the efficacy and safety of RF ablation in patients with BE containing LGD or HGD C/ÿ prior endoscopic resection (ER). Methods: Eligibility: BE 2-7 cm with LGD or HGD from R2 EGD sessions, visible abnormalities removed by ER prior to ablation, and esomeprazole 40 mg BID during study. The HALO360 ˆRRX Medical, Sunnyvale, CA) consists of a balloon-based Ablation System (BA electrode array which delivers a short burst of high power (300 W, !1 sec) RF energy to the BE tissue. Energy density (12 J/cm2) and balloon pressure are controlled, enabling uniform ablation depth. At baseline and 10 weeks, ablation was performed from the proximal margin of BE to the gastric folds. Post-ablation symptoms (odynophagia; dysphagia; chest, throat and abdominal pain) were assessed by 14-day visual analog scale (0-100 mm, VAS) survey. At 4 months, EGD, Lugol’s staining and biopsies (4Q/1 cm) were performed and histology was reviewed by an expert pathologist. Primary endpoint was complete response (CR) defined as absence of dysplasia at 4 months. Secondary endpoints: safety, VAS scores, and surface area regression of BE. Results: 11 pts (8 men, median age 60 yrs, IQR 55-67) were treated (median BE length 5 cm, IQR 3-7). Six pts had prior ER with early carcinoma (n Z 2), HGD (n Z 1) and LGD (n Z 3) in the resection specimens. Baseline diagnosis after ER and prior to ablation was LGD (n Z 1) and HGD (n Z 10). After 2 sessions, 10/11 patients are in CR for dysplasia (91% CR rate). The patient with persistent dysplasia, went from HGD to LGD and has only small residual islands of Barrett’s mucosa left. All procedures were performed on a outpatients’ basis and there were no serious adverse events, i.e., no strictures or buried glands. The median day #1 VAS was 27/100 (IQR 0-53) for chest pain, returning to 0/100 by day #5. The median day #1 VAS for other symptoms was 0/100 (max IQR 0-23 for odynophagia). Median BE regression was 90% (IQR 80-95) at 10 weeks, and 99% (IQR 95-99) at 4 months. Conclusions: Circumferential RF ablation using the HALO360 Ablation System appears to be a safe and effective treatment for BE containing LGD or HGD, with a 91% CR rate for dysplasia and minimal side effects. Patients now have very limited residual BE (mostly non-dysplastic) and are candidates for completion of treatment with a focal ablation device utilizing the same electrode array technology.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB137