- Email: [email protected]
639 Efficacy of Submucosal Tunneling Method for the Management of Superficial Esophageal Squamous Cell Carcinoma: A Propensity Score Matching Analysis
Abstracts
avoiding the need for esophagectomy. Poor tumor characteristics were present in 7 patients (64%); 3 patients were referred for esophagectomy, 1 for definitive chemoradiotherapy, and 3 patients receive ongoing endoscopic surveillance. Conclusion: This study demonstrates that 48% of cT2 EAC are pT1 tumors after histological examination of the esophagectomy specimen. Curative treatment by EMR is possible in 18-36% of these patients avoiding the need for esophagectomy. Endoscopic reassessment seems to be justified for all cT2N0M0 staged esophageal adenocarcinomas followed by EMR if deemed possible.
638 Multifocal Nitrous Oxide Cryoballoon Ablation With or Without Endoscopic Mucosal Resection (EMR) for Treatment of Neoplastic Barrett’s Esophagus (Be): Preliminary Results of a Prospective Clinical Trial in Treatment-Naive and Previously Ablated Patients Marcia I. Canto*1, Eun Ji Shin1, Mouen A. Khashab1, Hilary Cosby1, Jose A. Almario1, Lyssandra Voltaggio2, Elizabeth Montgomery2, Charles J. Lightdale3 1 Medicine (Gastroenterology), Johns Hopkins University, Baltimore, MD; 2 Pathology, Johns Hopkins Medical Institutions, Baltimore, MD; 3 Medicine(Digestive and Liver Disease), Columbia University Medical Center, New York, NY Radiofrequency ablation (RFA) is highly effective for treatment of BE. However, postablation pain, strictures, and bleeding can develop. Endoscopic cryotherapy (Cryo) can successfully eradicate neoplastic BE, including refractory disease, with low stricture rate and no bleeding. A new portable battery-powered system (cryoballoon focal ablation system or CbFAS) with a small hand-held device converts liquid nitrous oxide to gas resulting in an ice patch of approximately 2 cm2. The gas is contained within a low pressure compliant through-the-scope balloon making contact with the mucosa, obviating the need for intraluminal suction. Aim: To determine the safety and efficacy of nitrous oxide Cryo using a CbFAS for eradication of BE neoplasia. METHODS: In a single center, prospective single-arm clinical trial, consecutive BE patients with confirmed neoplasia without prior therapy (“treatment-naïve”) or persistent/recurrent disease despite prior therapies (“previously ablated”) were treated with CbFAS at dose 10 seconds of ice per site. EMR was performed prior to Cryo for lesions. Ablations were delivered from distal to proximal, beginning at the gastric cardia/GE junction, to include all visible BE with WLEHRE and NBI, followed by treatment of skip areas. Treatments were repeated every 10-12 weeks until eradication of intestinal metaplasia (IM). RESULTS: 35 patients with low grade dysplasia (LGD nZ14), high grade dysplasia (HGD nZ20) or T1aECA (nZ1) have had 66 treatments (Table 1). 12(34%) patients had prior ablation. EMR rate was 37%. All procedures were successful except for 2 with balloon migrations across strictures leading to incomplete ablation. Median ablation and procedure times were 18.3 (IQR 13-31) and 30.5 (24-44) minutes, respectively. 21 enrolled patients were evaluable. Median number of Cryo procedures was 2 (IQR1-3). Median follow-up time was 6.7 months (IQR 3.9-8.3 months). Short term complete response for all dysplasia (CRD) to date is 100% in 10 treatment-naïve and 11 previously ablated patients. To date, overall CR-D and CR-IM rates are 20/21(95%) and 15/21(71%), respectively (Table 2). No serious adverse events noted, including perforations or bleeding. Post-ablation pain requiring narcotics was reported in 8/35 (23%), none lasting > 48 hours, with median 24-hour 10-point Likert pain score of 2 (IQR 0-3). Three patients developed mild inflammatory stenosis (1 symptomatic, requiring dilation), all resolved. No patient had a persistent symptomatic stricture, including 9 with pre-existing post EMR/RFA strictures. CONCLUSION: Multifocal nitrous oxide cryoballoon ablation is a promising, safe, and potentially effective endoscopic treatment for primary or rescue therapy of BE-associated neoplasia. Device improvements are ongoing and larger multicenter comparative clinical trials are planned to assess long-term safety and efficacy.
Patient Characteristics
Pre-Ablation BE neoplasia grade Low grade dysplasia (LGD) High grade dysplasia (HGD) Intramucosal adenocarcinoma (T1a) Mean maximum BE length (range) in cm BE length by group Short (< 3 cm) Long (>Z 3cm to < 8 cm) Ultra-long (>Z 8 cm)
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TreatmentNaïve N[23
PreviouslyAblated N[12
All Patients N[35
10(43%) 12(52%) 1(4%)
4(33%) 8(67%) 0
14(40%) 20(57%) 1(3%)
4.1(1-14)
5.3(1-14)
4.5(1-14)
8(35%) 13(56%) 2(9%)
6(50%) 2(17%) 4(33%)
14(40%) 15(43%) 6(17%)
Mean age (range), in years Male gender (%) Prior endoscopic mucosal resection (EMR) Prior radiofrequency ablation Prior argon plasma coagulation (APC) Prior cryotherapy (Cryo) Esophageal stricture
TreatmentNaïve N[23
PreviouslyAblated N[12
All Patients N[35
67.1(46-77) 21(91%) 6(26%)
66.2(34-76) 10(83%) 7(58%)
66.8(34-77) 31(89%) 13(37%)
0 0
12(100%) 4(33%)
12(34%) 4(11%)
0 1(4%)
5(42%) 8(67%)
5(14%) 9(26%)
Response To Treatment in 21 Evaluable Patients Long BE Short BE 3 cm to < 8 Ultra-Long < 3 cm cm >[ 8 cm All N[11 N[6 N[4 N[21 Complete Response for All Dysplasia and Cancer (CR-D) Complete Response for Intestinal Metaplasia (CR-IM), esophagus, GEJ, and gastric cardia
10 (91%) 10 (91%)
6 (100%) 4 (67%)
4 (100%) 1 (25%)
20 (95%) 15 (71%)
* no statistical differences in response rates by BE length (pZ0.31, Fisher’s exact test).
639 Efficacy of Submucosal Tunneling Method for the Management of Superficial Esophageal Squamous Cell Carcinoma: A Propensity Score Matching Analysis Rui Huang, Honglin Yan, Hongwei Cai, Gui Ren, Linhui Zhang, Yanglin Pan, Zhiguo Liu*, Xuegang Guo, Kaichun Wu, Ying Han Xijing Hosptial of Digestive Disease, Xi, China Background and Aims: Endoscopic submucosal dissection (ESD) is becoming the treatment of choice for localized superficial gastrointestinal neoplasms recently. However, the procedure requires expertise and is generally a time-consuming procedure. Esophageal ESD is more technically challenging due to the facts of thinner wall and narrow lumen, which could result in complications including perforation. In this current retrospective study, we evaluated the efficacy of the tunneling method in ESD of superficial esophageal squamous cell carcinoma (ESCC). Methods: Superficial ESCC cases treated by ESD between October2013 and September 2015 at Xijing Hospital of Digestive Disease were retrospectively reviewed. Lesions treated by conventional ESD and tunneling ESD were compared. Propensity score matching was used to compensate for the differences in age, sex, resected specimen size and pathology. The procedure time and rates of en bloc, complete resection, curative resection and adverse events were compared between the two groups. Results: Totally 115 cases of superficial ESCC were treated by ESD between October 2013 and September 2015. Propensity score matching analysis created 38 matched pairs. In adjusted comparisons between tunneling and conventional ESD, there was no difference in the clinical outcomes including the en bloc resection rate (100 % vs. 100 %; P Z 1.000), the complete resection rate (100 % vs. 94.7 %; P Z 0.152) and the curative rate (94.7 % vs. 92.1 %; P Z 0.644). The ESD procedure time was 39.1 12.9 min in tunneling group compared to 66.6 55.1 min in conventional group. ESD with tunneling method had a significantly shorter procedure time than conventional method (P Z 0.005). There was no difference on adverse event rates including post-procedure bleeding (0 % vs. 2.6 %; P Z 0.314), perforation rate (0 %vs. 7.9 %; P Z 0.077) and thoracalgia (10.5 % vs. 10.5 %; P Z 1.000), but tunneling ESD group showed a lower rate of muscular injury (28.9 % vs. 52.6 %; P Z 0.036). In multivariate regression analysis for procedure time, the tunneling method (odds ratio, OR 3.42; 95 % confidence interval, 95 % CI 1.32 – 8.85; P Z 0.011) and specimen size < 40 mm (OR 8.74; 95 % CI 1.30 – 58.5; P Z 0.026) were associated with a shorter procedure time. Conclusion: Tunneling method improved the efficacy and safety of ESD procedure by shortening the procedure time and reducing injury to muscular layer, presumably by providing good visualization during submucosal dissection.
Volume 83, No. 5S : 2016 GASTROINTESTINAL ENDOSCOPY AB159
Abstracts Table. Matching factors and treatment outcomes between the tunneling
method group and control subjects after propensity score matching
Variables matched between groups Patient-related variables Age, y (Mean SD) Sex (Male/ Female) Lesion-related variables Specimen max. diameter (Mean SD) Pathology High-grade intraepithelial neoplasia (HGIN) Intramucosal carcinoma (pT1a) Submucosal invasive carcinoma (pT1b) Others Treatment outcomes Procedure time, min(Mean SD) En bloc resection Complete resection Curative resection Muscular injury during ESD Post-procedure bleeding Perforation Thoracalgia
Tunneling ESD group (n [ 38)
Conventional ESD group (n [ 38)
P value
58.7 7.8 33/5
58.9 10.6 34/4
0.912 0.723
39.8 12.0
40.6 17.4
0.813 0.343
18(47.3 %) 15(39.5 %) 5(13.2 %) 0(0 %)
17(44.5 %) 11(28.9 %) 8(21.1 %) 2(5.3 %)
39.1 12.9 38(100 %) 38(100 %) 36(94.7 %) 11(28.9 %) 0(0 %) 0(0 %) 4(10.5 %)
66.6 55.1 38(100 %) 36(94.7 %) 35(92.1 %) 20(52.6 %) 1(2.6 %) 3(7.9 %) 4(10.5 %)
0.005 1.000 0.152 0.644 0.036 0.314 0.077 1.000
640 Liquid Nitrogen Spray Cryotherapy is a Versatile Management Modality for Pre-Malignant and Malignant Lesions of the Esophagus: Results from a Multicenter U.S. Registry Swathi Eluri*1, Cary C. Cotton2, Brenda J. Hoffman4, Vivek Kaul5, Matthew McKinley3, Nicholas Shaheen1 1 Department of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC; 2University of North Carolina School of Medicine, Chapel Hill, NC; 3Gastroenterology, North Shore LIJ Health System and ProHEALTHcare Associates, Syosset and Lake Success, NY; 4Department of Gastroenterology, Medical University of South Carolina, Charleston, SC; 5Division of Gastroenterology & Hepatology, University of Rochester Medical Center & Strong Memorial Hospital, Rochester, NY Background: While liquid nitrogen spray cryotherapy (SCT) is an effective treatment used to eradicate Barrett’s esophagus (BE), the utility of SCT outside of clinical trials and in the management of other malignant and pre-malignant lesions of the esophagus is not as well described. Aim: To describe the patient characteristics of those receiving SCT in a multicenter U.S. registry and compare groups with malignant and pre-malignant esophageal lesions. Methods: This is a multicenter prospective registry of adult subjects managed with truFreeze SCT from 4 community and 11 academic sites in the United States. All subjects received SCT for the first time for malignant or pre-malignant conditions of the aerodigestive tract and will be followed for up to 5 years. Pre-malignant lesions were defined as baseline pathology of non-dysplastic BE (NDBE), indefinite dysplasia, low-grade dysplasia (LGD), or high-grade dysplasia (HGD). Malignant lesions were intramucosal adenocarcinoma (IMC), invasive adenocarcinoma, or squamous cell carcinoma. Bivariate analyses were used to compare the malignant and pre-malignant groups. A sub-analysis of the malignant subjects was done focusing on dosimetry and complications of SCT. Results: Among 137 subjects, mean age was 6912 years with a majority being white (94%) men (78%) (Table 1). Mean BMI was 306 and 63% had a smoking history. 50% (nZ65) had pre-malignant lesions with baseline HGD or lower and 50% (nZ64) had malignancy. The malignant group was older (72 vs. 67 years) and had more strictures (16% vs. 5%) (Table 2). Over a median follow-up time of 147 days, 13% of the malignant group achieved histologic clearance after 21 SCT sessions. Total dosimetry (seconds/spray site) received per session was higher for the malignant (55 22) versus pre-malignant (45 11; p<0.01) states with no difference in terms of adverse events (6% vs. 5%, pZ0.79). Among those with malignant lesions, 47% (nZ30) had IMC, 44% (nZ28) had invasive adenocarcinoma and 9% (nZ6) had squamous cell carcinoma. They received a median of 2 (range: 1-5) SCT sessions consisting on average 2.40.8 cycles ranging from 20-30 seconds each, during a follow-up period of 114 (range 0-637) days. There was also no difference in the number of SCT sessions (21 vs. 21, pZ0.67) or mean total dosimetry (sec/site) per session (6823 vs. 5322, pZ0.14) between those with squamous and adenocarcinoma. There were three significant adverse events in the malignant group: hematemesis, pain, and death due to progression of metastatic adenocarcinoma unrelated to procedure. Conclusion: In a national registry of users of liquid nitrogen SCT, a substantial proportion of use was for patients with malignant disease. Dosimetry was on average higher for patients being treated for malignancy than for pre-malignant states, however adverse events were not significantly different.
Figure. A representative tunneling ESD case. A. A redish flat lesion was found in the middle esophagus; B. Narrow band imaging revealed B1 vessels according to Japanese Esophagus Society Classification which indicating an early cancer with an invasion depth of m1/m2; C. Iodine staining showed an iodine void lesion. After marking the border of the lesion (D), normal saline was injected into the submucosal space, and mucosa incisions were made at anal (E) and oral side (F) of the lesion. Sumucosal tissue was dissected between anal and oral incisions to form a tunnel underneath the lesion and a clear vision of submucosal layer was maintained. Then the circumferential cutting of mucosa was complete (H & I). The remaining submusal tissue was further dissected to finish the ESD procedure (J & K). Pathological analysis revealed high grade intraepithelial neopasia (Blue lines) in low grode intraepithelial neopasia backgroud (Red lines) with clear horizontal and vertical margins.
AB160 GASTROINTESTINAL ENDOSCOPY Volume 83, No. 5S : 2016
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avoiding the need for esophagectomy. Poor tumor characteristics were present in 7 patients (64%); 3 patients were referred for esophagectomy, 1 for definitive chemoradiotherapy, and 3 patients receive ongoing endoscopic surveillance. Conclusion: This study demonstrates that 48% of cT2 EAC are pT1 tumors after histological examination of the esophagectomy specimen. Curative treatment by EMR is possible in 18-36% of these patients avoiding the need for esophagectomy. Endoscopic reassessment seems to be justified for all cT2N0M0 staged esophageal adenocarcinomas followed by EMR if deemed possible.
638 Multifocal Nitrous Oxide Cryoballoon Ablation With or Without Endoscopic Mucosal Resection (EMR) for Treatment of Neoplastic Barrett’s Esophagus (Be): Preliminary Results of a Prospective Clinical Trial in Treatment-Naive and Previously Ablated Patients Marcia I. Canto*1, Eun Ji Shin1, Mouen A. Khashab1, Hilary Cosby1, Jose A. Almario1, Lyssandra Voltaggio2, Elizabeth Montgomery2, Charles J. Lightdale3 1 Medicine (Gastroenterology), Johns Hopkins University, Baltimore, MD; 2 Pathology, Johns Hopkins Medical Institutions, Baltimore, MD; 3 Medicine(Digestive and Liver Disease), Columbia University Medical Center, New York, NY Radiofrequency ablation (RFA) is highly effective for treatment of BE. However, postablation pain, strictures, and bleeding can develop. Endoscopic cryotherapy (Cryo) can successfully eradicate neoplastic BE, including refractory disease, with low stricture rate and no bleeding. A new portable battery-powered system (cryoballoon focal ablation system or CbFAS) with a small hand-held device converts liquid nitrous oxide to gas resulting in an ice patch of approximately 2 cm2. The gas is contained within a low pressure compliant through-the-scope balloon making contact with the mucosa, obviating the need for intraluminal suction. Aim: To determine the safety and efficacy of nitrous oxide Cryo using a CbFAS for eradication of BE neoplasia. METHODS: In a single center, prospective single-arm clinical trial, consecutive BE patients with confirmed neoplasia without prior therapy (“treatment-naïve”) or persistent/recurrent disease despite prior therapies (“previously ablated”) were treated with CbFAS at dose 10 seconds of ice per site. EMR was performed prior to Cryo for lesions. Ablations were delivered from distal to proximal, beginning at the gastric cardia/GE junction, to include all visible BE with WLEHRE and NBI, followed by treatment of skip areas. Treatments were repeated every 10-12 weeks until eradication of intestinal metaplasia (IM). RESULTS: 35 patients with low grade dysplasia (LGD nZ14), high grade dysplasia (HGD nZ20) or T1aECA (nZ1) have had 66 treatments (Table 1). 12(34%) patients had prior ablation. EMR rate was 37%. All procedures were successful except for 2 with balloon migrations across strictures leading to incomplete ablation. Median ablation and procedure times were 18.3 (IQR 13-31) and 30.5 (24-44) minutes, respectively. 21 enrolled patients were evaluable. Median number of Cryo procedures was 2 (IQR1-3). Median follow-up time was 6.7 months (IQR 3.9-8.3 months). Short term complete response for all dysplasia (CRD) to date is 100% in 10 treatment-naïve and 11 previously ablated patients. To date, overall CR-D and CR-IM rates are 20/21(95%) and 15/21(71%), respectively (Table 2). No serious adverse events noted, including perforations or bleeding. Post-ablation pain requiring narcotics was reported in 8/35 (23%), none lasting > 48 hours, with median 24-hour 10-point Likert pain score of 2 (IQR 0-3). Three patients developed mild inflammatory stenosis (1 symptomatic, requiring dilation), all resolved. No patient had a persistent symptomatic stricture, including 9 with pre-existing post EMR/RFA strictures. CONCLUSION: Multifocal nitrous oxide cryoballoon ablation is a promising, safe, and potentially effective endoscopic treatment for primary or rescue therapy of BE-associated neoplasia. Device improvements are ongoing and larger multicenter comparative clinical trials are planned to assess long-term safety and efficacy.
Patient Characteristics
Pre-Ablation BE neoplasia grade Low grade dysplasia (LGD) High grade dysplasia (HGD) Intramucosal adenocarcinoma (T1a) Mean maximum BE length (range) in cm BE length by group Short (< 3 cm) Long (>Z 3cm to < 8 cm) Ultra-long (>Z 8 cm)
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TreatmentNaïve N[23
PreviouslyAblated N[12
All Patients N[35
10(43%) 12(52%) 1(4%)
4(33%) 8(67%) 0
14(40%) 20(57%) 1(3%)
4.1(1-14)
5.3(1-14)
4.5(1-14)
8(35%) 13(56%) 2(9%)
6(50%) 2(17%) 4(33%)
14(40%) 15(43%) 6(17%)
Mean age (range), in years Male gender (%) Prior endoscopic mucosal resection (EMR) Prior radiofrequency ablation Prior argon plasma coagulation (APC) Prior cryotherapy (Cryo) Esophageal stricture
TreatmentNaïve N[23
PreviouslyAblated N[12
All Patients N[35
67.1(46-77) 21(91%) 6(26%)
66.2(34-76) 10(83%) 7(58%)
66.8(34-77) 31(89%) 13(37%)
0 0
12(100%) 4(33%)
12(34%) 4(11%)
0 1(4%)
5(42%) 8(67%)
5(14%) 9(26%)
Response To Treatment in 21 Evaluable Patients Long BE Short BE 3 cm to < 8 Ultra-Long < 3 cm cm >[ 8 cm All N[11 N[6 N[4 N[21 Complete Response for All Dysplasia and Cancer (CR-D) Complete Response for Intestinal Metaplasia (CR-IM), esophagus, GEJ, and gastric cardia
10 (91%) 10 (91%)
6 (100%) 4 (67%)
4 (100%) 1 (25%)
20 (95%) 15 (71%)
* no statistical differences in response rates by BE length (pZ0.31, Fisher’s exact test).
639 Efficacy of Submucosal Tunneling Method for the Management of Superficial Esophageal Squamous Cell Carcinoma: A Propensity Score Matching Analysis Rui Huang, Honglin Yan, Hongwei Cai, Gui Ren, Linhui Zhang, Yanglin Pan, Zhiguo Liu*, Xuegang Guo, Kaichun Wu, Ying Han Xijing Hosptial of Digestive Disease, Xi, China Background and Aims: Endoscopic submucosal dissection (ESD) is becoming the treatment of choice for localized superficial gastrointestinal neoplasms recently. However, the procedure requires expertise and is generally a time-consuming procedure. Esophageal ESD is more technically challenging due to the facts of thinner wall and narrow lumen, which could result in complications including perforation. In this current retrospective study, we evaluated the efficacy of the tunneling method in ESD of superficial esophageal squamous cell carcinoma (ESCC). Methods: Superficial ESCC cases treated by ESD between October2013 and September 2015 at Xijing Hospital of Digestive Disease were retrospectively reviewed. Lesions treated by conventional ESD and tunneling ESD were compared. Propensity score matching was used to compensate for the differences in age, sex, resected specimen size and pathology. The procedure time and rates of en bloc, complete resection, curative resection and adverse events were compared between the two groups. Results: Totally 115 cases of superficial ESCC were treated by ESD between October 2013 and September 2015. Propensity score matching analysis created 38 matched pairs. In adjusted comparisons between tunneling and conventional ESD, there was no difference in the clinical outcomes including the en bloc resection rate (100 % vs. 100 %; P Z 1.000), the complete resection rate (100 % vs. 94.7 %; P Z 0.152) and the curative rate (94.7 % vs. 92.1 %; P Z 0.644). The ESD procedure time was 39.1 12.9 min in tunneling group compared to 66.6 55.1 min in conventional group. ESD with tunneling method had a significantly shorter procedure time than conventional method (P Z 0.005). There was no difference on adverse event rates including post-procedure bleeding (0 % vs. 2.6 %; P Z 0.314), perforation rate (0 %vs. 7.9 %; P Z 0.077) and thoracalgia (10.5 % vs. 10.5 %; P Z 1.000), but tunneling ESD group showed a lower rate of muscular injury (28.9 % vs. 52.6 %; P Z 0.036). In multivariate regression analysis for procedure time, the tunneling method (odds ratio, OR 3.42; 95 % confidence interval, 95 % CI 1.32 – 8.85; P Z 0.011) and specimen size < 40 mm (OR 8.74; 95 % CI 1.30 – 58.5; P Z 0.026) were associated with a shorter procedure time. Conclusion: Tunneling method improved the efficacy and safety of ESD procedure by shortening the procedure time and reducing injury to muscular layer, presumably by providing good visualization during submucosal dissection.
Volume 83, No. 5S : 2016 GASTROINTESTINAL ENDOSCOPY AB159
Abstracts Table. Matching factors and treatment outcomes between the tunneling
method group and control subjects after propensity score matching
Variables matched between groups Patient-related variables Age, y (Mean SD) Sex (Male/ Female) Lesion-related variables Specimen max. diameter (Mean SD) Pathology High-grade intraepithelial neoplasia (HGIN) Intramucosal carcinoma (pT1a) Submucosal invasive carcinoma (pT1b) Others Treatment outcomes Procedure time, min(Mean SD) En bloc resection Complete resection Curative resection Muscular injury during ESD Post-procedure bleeding Perforation Thoracalgia
Tunneling ESD group (n [ 38)
Conventional ESD group (n [ 38)
P value
58.7 7.8 33/5
58.9 10.6 34/4
0.912 0.723
39.8 12.0
40.6 17.4
0.813 0.343
18(47.3 %) 15(39.5 %) 5(13.2 %) 0(0 %)
17(44.5 %) 11(28.9 %) 8(21.1 %) 2(5.3 %)
39.1 12.9 38(100 %) 38(100 %) 36(94.7 %) 11(28.9 %) 0(0 %) 0(0 %) 4(10.5 %)
66.6 55.1 38(100 %) 36(94.7 %) 35(92.1 %) 20(52.6 %) 1(2.6 %) 3(7.9 %) 4(10.5 %)
0.005 1.000 0.152 0.644 0.036 0.314 0.077 1.000
640 Liquid Nitrogen Spray Cryotherapy is a Versatile Management Modality for Pre-Malignant and Malignant Lesions of the Esophagus: Results from a Multicenter U.S. Registry Swathi Eluri*1, Cary C. Cotton2, Brenda J. Hoffman4, Vivek Kaul5, Matthew McKinley3, Nicholas Shaheen1 1 Department of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC; 2University of North Carolina School of Medicine, Chapel Hill, NC; 3Gastroenterology, North Shore LIJ Health System and ProHEALTHcare Associates, Syosset and Lake Success, NY; 4Department of Gastroenterology, Medical University of South Carolina, Charleston, SC; 5Division of Gastroenterology & Hepatology, University of Rochester Medical Center & Strong Memorial Hospital, Rochester, NY Background: While liquid nitrogen spray cryotherapy (SCT) is an effective treatment used to eradicate Barrett’s esophagus (BE), the utility of SCT outside of clinical trials and in the management of other malignant and pre-malignant lesions of the esophagus is not as well described. Aim: To describe the patient characteristics of those receiving SCT in a multicenter U.S. registry and compare groups with malignant and pre-malignant esophageal lesions. Methods: This is a multicenter prospective registry of adult subjects managed with truFreeze SCT from 4 community and 11 academic sites in the United States. All subjects received SCT for the first time for malignant or pre-malignant conditions of the aerodigestive tract and will be followed for up to 5 years. Pre-malignant lesions were defined as baseline pathology of non-dysplastic BE (NDBE), indefinite dysplasia, low-grade dysplasia (LGD), or high-grade dysplasia (HGD). Malignant lesions were intramucosal adenocarcinoma (IMC), invasive adenocarcinoma, or squamous cell carcinoma. Bivariate analyses were used to compare the malignant and pre-malignant groups. A sub-analysis of the malignant subjects was done focusing on dosimetry and complications of SCT. Results: Among 137 subjects, mean age was 6912 years with a majority being white (94%) men (78%) (Table 1). Mean BMI was 306 and 63% had a smoking history. 50% (nZ65) had pre-malignant lesions with baseline HGD or lower and 50% (nZ64) had malignancy. The malignant group was older (72 vs. 67 years) and had more strictures (16% vs. 5%) (Table 2). Over a median follow-up time of 147 days, 13% of the malignant group achieved histologic clearance after 21 SCT sessions. Total dosimetry (seconds/spray site) received per session was higher for the malignant (55 22) versus pre-malignant (45 11; p<0.01) states with no difference in terms of adverse events (6% vs. 5%, pZ0.79). Among those with malignant lesions, 47% (nZ30) had IMC, 44% (nZ28) had invasive adenocarcinoma and 9% (nZ6) had squamous cell carcinoma. They received a median of 2 (range: 1-5) SCT sessions consisting on average 2.40.8 cycles ranging from 20-30 seconds each, during a follow-up period of 114 (range 0-637) days. There was also no difference in the number of SCT sessions (21 vs. 21, pZ0.67) or mean total dosimetry (sec/site) per session (6823 vs. 5322, pZ0.14) between those with squamous and adenocarcinoma. There were three significant adverse events in the malignant group: hematemesis, pain, and death due to progression of metastatic adenocarcinoma unrelated to procedure. Conclusion: In a national registry of users of liquid nitrogen SCT, a substantial proportion of use was for patients with malignant disease. Dosimetry was on average higher for patients being treated for malignancy than for pre-malignant states, however adverse events were not significantly different.
Figure. A representative tunneling ESD case. A. A redish flat lesion was found in the middle esophagus; B. Narrow band imaging revealed B1 vessels according to Japanese Esophagus Society Classification which indicating an early cancer with an invasion depth of m1/m2; C. Iodine staining showed an iodine void lesion. After marking the border of the lesion (D), normal saline was injected into the submucosal space, and mucosa incisions were made at anal (E) and oral side (F) of the lesion. Sumucosal tissue was dissected between anal and oral incisions to form a tunnel underneath the lesion and a clear vision of submucosal layer was maintained. Then the circumferential cutting of mucosa was complete (H & I). The remaining submusal tissue was further dissected to finish the ESD procedure (J & K). Pathological analysis revealed high grade intraepithelial neopasia (Blue lines) in low grode intraepithelial neopasia backgroud (Red lines) with clear horizontal and vertical margins.
AB160 GASTROINTESTINAL ENDOSCOPY Volume 83, No. 5S : 2016
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