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A Prospective Double Blind Comparison of Endoscopic Ultrasound, Endobronchial Ultrasound, and Bronchoscopic Fine Needle Aspiration for Malignant Mediastinal Lymph Nodes
Abstracts
434 Assessing the Prevalence and Risk Factors for Advanced Colonic Neoplasia in Asymptomatic, Average-Risk Women, 50-59 Years of Age Jeffrey S. Zaidman, Christopher Fyock, Steven Reinert, Sripathi R. Kethu Background: There is a growing need to risk stratify average-risk individuals to guide optimal resource utilization for colon cancer screening. Among asymptomatic patients who undergo screening colonoscopy, the overall prevalence of advanced colonic neoplasia is low (3.4%-7%), and the prevalence is even lower in women in the 50-59 years age group. There are no published studies that evaluated risk factors associated with advanced neoplasia in average-risk women below 60 years of age. Risk-stratifying this lowest risk population could identify subgroups that may safely delay colonoscopy. Methods: This is a retrospective cohort study of consecutive asymptomatic women 50-59 years old, who underwent average-risk screening colonoscopy. Colonoscopy and pathology reports were reviewed to obtain data regarding the patient’s age and number, size, and histology of the polyps. Telephone interviews and mailed surveys were conducted to collect data on race, body mass index (BMI), smoking, consumption of alcohol and coffee, history of diabetes, and prior cholecystectomy. Advanced neoplasia was defined as tubular adenoma measuring 1 cm or larger, any villous histology, high-grade dysplasia, or cancer. Results: A total of 1,116 persons underwent average-risk screening colonoscopy during the 13-month study period (May 2005 to May 2006). Among them, 274 (25%) were women between 50 and 59 years of age. Overall prevalence of colorectal neoplasia was 26% (70 of 274 women) in the 50-59 years age group, among them 19% had non-advanced neoplasia and 6% had advanced neoplasia. Compared with non-diabetics in the study, women with diabetes had a significantly increased risk of colonic neoplasia in general (45.8% vs. 25.5%, odds ratio 3.0) and advanced neoplasia (16.7 vs. 5.8, odds ratio 4.2). This risk was independent of all other variables including BMI and age. Women in the 50-54 years age group had significantly decreased risk of colonic neoplasia compared with women aged 55-59 years (non-advanced neoplasia:19% vs. 33%, odds ratio 2.3; advanced neoplasia: 3.4% vs. 9.5%, odds ratio 3.0). Women in the 50-54 years age group without diabetes had a 4.0% prevalence of advanced neoplasia. This prevalence rate of advanced neoplasia is similar to that of average-risk patients aged 40-49 years reported in previously published studies, in whom screening colonoscopy is not currently recommended. Conclusions: Diabetes increases the risk of advanced colonic neoplasia in women independent of BMI. Women in the 50-54 years age group without diabetes have the lowest risk for advanced neoplasia and therefore may defer colonoscopy until after age 55 years.
lateral to the trachea (level 2L/R, 4L/R), aortopulmonary window, subcarina and lower mediastinum (level 8-9). There were no cases where bronchoscopy detected malignant nodes which were not detected by eus or ebus. Conclusions: EUS and EBUS are both superior to bronchoscopic FNA for detection of malignant mediastinal lymph nodes. Bronchoscopic FNA had no incremental yield compared to the combination of EUS and EBUS. EUS and EBUS, in combination, allow nearcomplete, ‘‘medical mediastinoscopy’’ under conscious sedation in patients with lung tumors and enlarged mediastinal lymph nodes. Per patient accuracy Procedure
Sensitivity
Specificity
Bronchoscopy-FNA EBUS-FNA EUS- FNA
36% 70% 73%
100% 100% 100%
Bronch þ EBUS EBUS þ EUS
82% 95%
100% 100%
Bronch þ EUS
77%
100%
p value !0.002 (vs bronch) !0.001 (vs bronch), O 0.2 (vs ebus) !0.03 (vs bronch þ ebus), !0.025 (vs eus þ bronch) Z0.09 (vs eus þ ebus), O 0.2 (vs bronch þ ebus)
Procedure duration Procedure
Duration (median minutes)
EUS-FNA EBUS-FNA Bronch-FNA
21 26 15
478 Prediction of the Chemotherapeutic Efficacy for Advanced Pancreatic Cancer By Focused DNA Array Analysis Using Endoscopic Ultrasound-Guided Fine-Needle Aspiration Reiko Ashida, Bunzo Nakata, Nobumasa Mizuno, Akira Sawaki, Kazuhide Higuchi, Kosei C. Hirakawa, Tetsuo Arakawa, Masakazu Fukushima, Kenji Yamao
477 A Prospective Double Blind Comparison of Endoscopic Ultrasound, Endobronchial Ultrasound, and Bronchoscopic Fine Needle Aspiration for Malignant Mediastinal Lymph Nodes Michael B. Wallace, Jorge M. Pascual, Massimo Raimondo, Timothy A. Woodward, Barbara Mccomb, Margaret M. Johnson, Mohammad A. Al-Haddad, Seth A. Gross, Joy Hardee, John Odell Background: EUS is the preferred modality for staging the posterior mediastinum in lung cancer. Recently, endobronchial ultrasound was developed to access the anterior mediastinum. We report final results of a prospective, blinded trial comparing the accuracy and feasibility of each modality. Methods: Patients with lung tumors or enlarged mediastinal lymph nodes underwent combined EUS-FNA, EBUS-FNA and bronchoscopy-FNA, under a single conscious sedation. EBUS and bronch-FNA were performed by pulmonologists who were blinded to EUS results. EUS was performed by gastroenterologists blinded to the results of bronch and EBUS. Patients without metastatic disease on all three procedures underwent surgery or close clinical follow up. Results: One hundred thirty eight patients were included. Sixty two malignant lymph nodes were detected in 44 patients by at least one procedure including 7 with small cell and 4 with lymphoma. Seven patients were confirmed by FNA to have sarcoidosis. The detection accuracy for malignancy for each procedure and combination of procedures on a per-patient basis in table 1. Procedure duration is shown in table 2. The combination of EUS and EBUS detected all patients with malignant lymph nodes except two, both with malignant nodes anterior to the aortic arch (level 6). All endoscopic procedures were completed without complications. EBUS detected lymph nodes in the anterior (AJCC level 2, 3, 4) mediastinum and subcarina, whereas EUS detected lymph nodes
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Background: Patients with unresectable pancreatic cancers have extremely poor prognosis. The ineffective anti-cancer drugs, which cause adverse effect alone, should not be given to the patient with this dismal disease. It is an urgent investigational subject to predict the effectiveness of anti-cancer agent against pancreatic cancer prior to treatment. We examined the usefulness of Focused DNA Array (FDA) analysis using the pancreatic cancer tissue obtained by endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) for the prediction of chemotherapeutic effect. Methods: Tissues from 21 unresectable pancreatic cancers were obtained by EUS-FNA using the 19 or 22-gauge needle. Total mRNA was harvested from each sample, and cDNA was composed by reverse transcription polymerase chain reaction (RT-PCR). Expression of RNA was evaluated using FDA which was restricted to 133 genes including drug-resistance related genes. The amount of RNA was expressed as the relative value to house keeping gene. Result: Gemcitabine (GEM) was given to 17 patients. One course of GEM regimen composed 1000 mg/m2 weekly administration for three weeks following one week rest. Eleven patients completed 3 courses or more of this regimen were divided into the following two groups. Three patients with PR and three patients with tumor marker reduction by 50% or more were classified as responders. The other five patients were classified as non-responders. By the FDA, we measured the mRNA expression of dCMP deaminase (DCD) and RRM1 genes, which may act as GEM-resistant factors, and deoxycytidine kinase (DCK) gene, which may act as GEM-sensitive factor. Our gene scoring was defined as following. When the mRNA amount was half or less in GEM-resistant factors or twice or more in GEM-sensitive factor, compared to the mean amount of corresponding mRNA in all 21 tissues, one point was added to the gene score. When the mRNA amount was twice or more in GEM-resistant factors or half or less in GEM-sensitive factor, one point was subtracted from the gene score. In six responders, four tumors showed þ1 (gene score) and two did þ2. In five non-responders, one tumor indicated 1, three did zero point, and one did þ1. When the gene score of þ1 or more point was defined as a predictive indicator for GEM-efficacy, the sensitivity, specificity and accuracy were 100%, 80% and 91%, respectively. Conclusion: The FDA chip is loaded with many other genes related to 5-fluorouracil, cisplatin, molecular targeting agents, and so on, besides GEM. The gene analysis using a sample taken by EUS-FNA might be useful to predict the chemothrapeutic efficacy for patients with unresectable pancreatic cancer.
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB101
434 Assessing the Prevalence and Risk Factors for Advanced Colonic Neoplasia in Asymptomatic, Average-Risk Women, 50-59 Years of Age Jeffrey S. Zaidman, Christopher Fyock, Steven Reinert, Sripathi R. Kethu Background: There is a growing need to risk stratify average-risk individuals to guide optimal resource utilization for colon cancer screening. Among asymptomatic patients who undergo screening colonoscopy, the overall prevalence of advanced colonic neoplasia is low (3.4%-7%), and the prevalence is even lower in women in the 50-59 years age group. There are no published studies that evaluated risk factors associated with advanced neoplasia in average-risk women below 60 years of age. Risk-stratifying this lowest risk population could identify subgroups that may safely delay colonoscopy. Methods: This is a retrospective cohort study of consecutive asymptomatic women 50-59 years old, who underwent average-risk screening colonoscopy. Colonoscopy and pathology reports were reviewed to obtain data regarding the patient’s age and number, size, and histology of the polyps. Telephone interviews and mailed surveys were conducted to collect data on race, body mass index (BMI), smoking, consumption of alcohol and coffee, history of diabetes, and prior cholecystectomy. Advanced neoplasia was defined as tubular adenoma measuring 1 cm or larger, any villous histology, high-grade dysplasia, or cancer. Results: A total of 1,116 persons underwent average-risk screening colonoscopy during the 13-month study period (May 2005 to May 2006). Among them, 274 (25%) were women between 50 and 59 years of age. Overall prevalence of colorectal neoplasia was 26% (70 of 274 women) in the 50-59 years age group, among them 19% had non-advanced neoplasia and 6% had advanced neoplasia. Compared with non-diabetics in the study, women with diabetes had a significantly increased risk of colonic neoplasia in general (45.8% vs. 25.5%, odds ratio 3.0) and advanced neoplasia (16.7 vs. 5.8, odds ratio 4.2). This risk was independent of all other variables including BMI and age. Women in the 50-54 years age group had significantly decreased risk of colonic neoplasia compared with women aged 55-59 years (non-advanced neoplasia:19% vs. 33%, odds ratio 2.3; advanced neoplasia: 3.4% vs. 9.5%, odds ratio 3.0). Women in the 50-54 years age group without diabetes had a 4.0% prevalence of advanced neoplasia. This prevalence rate of advanced neoplasia is similar to that of average-risk patients aged 40-49 years reported in previously published studies, in whom screening colonoscopy is not currently recommended. Conclusions: Diabetes increases the risk of advanced colonic neoplasia in women independent of BMI. Women in the 50-54 years age group without diabetes have the lowest risk for advanced neoplasia and therefore may defer colonoscopy until after age 55 years.
lateral to the trachea (level 2L/R, 4L/R), aortopulmonary window, subcarina and lower mediastinum (level 8-9). There were no cases where bronchoscopy detected malignant nodes which were not detected by eus or ebus. Conclusions: EUS and EBUS are both superior to bronchoscopic FNA for detection of malignant mediastinal lymph nodes. Bronchoscopic FNA had no incremental yield compared to the combination of EUS and EBUS. EUS and EBUS, in combination, allow nearcomplete, ‘‘medical mediastinoscopy’’ under conscious sedation in patients with lung tumors and enlarged mediastinal lymph nodes. Per patient accuracy Procedure
Sensitivity
Specificity
Bronchoscopy-FNA EBUS-FNA EUS- FNA
36% 70% 73%
100% 100% 100%
Bronch þ EBUS EBUS þ EUS
82% 95%
100% 100%
Bronch þ EUS
77%
100%
p value !0.002 (vs bronch) !0.001 (vs bronch), O 0.2 (vs ebus) !0.03 (vs bronch þ ebus), !0.025 (vs eus þ bronch) Z0.09 (vs eus þ ebus), O 0.2 (vs bronch þ ebus)
Procedure duration Procedure
Duration (median minutes)
EUS-FNA EBUS-FNA Bronch-FNA
21 26 15
478 Prediction of the Chemotherapeutic Efficacy for Advanced Pancreatic Cancer By Focused DNA Array Analysis Using Endoscopic Ultrasound-Guided Fine-Needle Aspiration Reiko Ashida, Bunzo Nakata, Nobumasa Mizuno, Akira Sawaki, Kazuhide Higuchi, Kosei C. Hirakawa, Tetsuo Arakawa, Masakazu Fukushima, Kenji Yamao
477 A Prospective Double Blind Comparison of Endoscopic Ultrasound, Endobronchial Ultrasound, and Bronchoscopic Fine Needle Aspiration for Malignant Mediastinal Lymph Nodes Michael B. Wallace, Jorge M. Pascual, Massimo Raimondo, Timothy A. Woodward, Barbara Mccomb, Margaret M. Johnson, Mohammad A. Al-Haddad, Seth A. Gross, Joy Hardee, John Odell Background: EUS is the preferred modality for staging the posterior mediastinum in lung cancer. Recently, endobronchial ultrasound was developed to access the anterior mediastinum. We report final results of a prospective, blinded trial comparing the accuracy and feasibility of each modality. Methods: Patients with lung tumors or enlarged mediastinal lymph nodes underwent combined EUS-FNA, EBUS-FNA and bronchoscopy-FNA, under a single conscious sedation. EBUS and bronch-FNA were performed by pulmonologists who were blinded to EUS results. EUS was performed by gastroenterologists blinded to the results of bronch and EBUS. Patients without metastatic disease on all three procedures underwent surgery or close clinical follow up. Results: One hundred thirty eight patients were included. Sixty two malignant lymph nodes were detected in 44 patients by at least one procedure including 7 with small cell and 4 with lymphoma. Seven patients were confirmed by FNA to have sarcoidosis. The detection accuracy for malignancy for each procedure and combination of procedures on a per-patient basis in table 1. Procedure duration is shown in table 2. The combination of EUS and EBUS detected all patients with malignant lymph nodes except two, both with malignant nodes anterior to the aortic arch (level 6). All endoscopic procedures were completed without complications. EBUS detected lymph nodes in the anterior (AJCC level 2, 3, 4) mediastinum and subcarina, whereas EUS detected lymph nodes
www.giejournal.org
Background: Patients with unresectable pancreatic cancers have extremely poor prognosis. The ineffective anti-cancer drugs, which cause adverse effect alone, should not be given to the patient with this dismal disease. It is an urgent investigational subject to predict the effectiveness of anti-cancer agent against pancreatic cancer prior to treatment. We examined the usefulness of Focused DNA Array (FDA) analysis using the pancreatic cancer tissue obtained by endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) for the prediction of chemotherapeutic effect. Methods: Tissues from 21 unresectable pancreatic cancers were obtained by EUS-FNA using the 19 or 22-gauge needle. Total mRNA was harvested from each sample, and cDNA was composed by reverse transcription polymerase chain reaction (RT-PCR). Expression of RNA was evaluated using FDA which was restricted to 133 genes including drug-resistance related genes. The amount of RNA was expressed as the relative value to house keeping gene. Result: Gemcitabine (GEM) was given to 17 patients. One course of GEM regimen composed 1000 mg/m2 weekly administration for three weeks following one week rest. Eleven patients completed 3 courses or more of this regimen were divided into the following two groups. Three patients with PR and three patients with tumor marker reduction by 50% or more were classified as responders. The other five patients were classified as non-responders. By the FDA, we measured the mRNA expression of dCMP deaminase (DCD) and RRM1 genes, which may act as GEM-resistant factors, and deoxycytidine kinase (DCK) gene, which may act as GEM-sensitive factor. Our gene scoring was defined as following. When the mRNA amount was half or less in GEM-resistant factors or twice or more in GEM-sensitive factor, compared to the mean amount of corresponding mRNA in all 21 tissues, one point was added to the gene score. When the mRNA amount was twice or more in GEM-resistant factors or half or less in GEM-sensitive factor, one point was subtracted from the gene score. In six responders, four tumors showed þ1 (gene score) and two did þ2. In five non-responders, one tumor indicated 1, three did zero point, and one did þ1. When the gene score of þ1 or more point was defined as a predictive indicator for GEM-efficacy, the sensitivity, specificity and accuracy were 100%, 80% and 91%, respectively. Conclusion: The FDA chip is loaded with many other genes related to 5-fluorouracil, cisplatin, molecular targeting agents, and so on, besides GEM. The gene analysis using a sample taken by EUS-FNA might be useful to predict the chemothrapeutic efficacy for patients with unresectable pancreatic cancer.
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB101