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Clinical Implications of the Extent of Invasion of T3 Esophageal Cancer as Determined by Endoscopic Ultrasound
*S1588 Development of an Instrument to Predict Endoscopic Tolerance Luis R. Pena, Houssam Mardini, Nicholas Nickl Background: Despite conscious sedation, up to 25% of patients may be dissatisfied during endoscopy with sedation, leading to poor procedure tolerance or procedure avoidance. Alternatives to standard conscious sedation include unsedated endoscopy, nitrous oxide, and propofol; each well accepted, but none universally appropriate. Reliable methods to predict patient aversive experience or to direct patients to appropriate options do not exist. Our group has been developing a questionnaire to reliably identify patients who will experience endoscopy adversely. Aims: To validate a questionnaire instrument as a predictor of aversive endoscopic experience in a group of outpatients. Methods: 150 unselected patients for routine endoscopy were included. Pre- and post-procedure questionnaires were given. The first questionnaire elicited demographics, education level, prior endoscopic experience, history of drugs or alcohol use, and levels of anxiety and nervousness before the test. After endoscopy, procedure tolerance and willingness to repeat the examination were determined. The primary outcome of adverse endoscopic experience was defined as a score of 5/10 or greater on the postprocedure overall level of satisfaction or unwillingness to repeat the endoscopy. Results: Among 148 subjects who completed the study 10% had an adverse endoscopic experience. The primary outcome was internally validated by univariate analysis which showed significant correlation with measures of aversive experience like pain, nervousness, or suffering during the procedure. The only preprocedure factors that correlated with an adverse endoscopic experience in the univariate analysis were nervousness (p=0.039) and chronic use of psychotropic drugs (chronic pain medications, recreational drugs, chronic benzodiazepine, or SSRI) or alcohol (p=0.037). The same factors also correlated in the multivariate analysis. Conclusion: We have identified some factors that will help refine a preprocedure questionnaire that may reliably predict poor endoscopic satisfaction. This will further help to appropriately direct sedation. A prospective randomized trial is being planned to test this instrument.
*S1589 Development of a Decision Board to Elicit Patient Preferences for Palliation of Dysphagia due to Unresectable Esophageal Cancer Charles B. Evans, Leslie Nelson, Tamir Ben-Menachem PURPOSE: Patients with malignant dysphagia due to unresectable esophageal cancer are faced with the complex task of choosing between palliative options with very different risks and benefits. We developed and tested a decision board (DB) to aid patients in choosing between a self-expanding metal stent (SEMS) and a percutaneous endoscopic gastrostomy tube (PEG). METHODS: Elements to include in the DB were determined by 1) assessment of the efficacy and risks of the procedures by literature review and medical record review of patients receiving SEMS (n=102); and 2) assessment of individual experiences, concerns and expectations by interviewing patients with esophageal cancer and dysphagia, and healthcare professionals with expertise treating this population. Using these input, a 24 3 36 inch DB with columns of statements describing in lay terms the techniques, benefits and risks of SEMS and PEG was created, reviewed, and revised for content and clarity. The testing phase included forty healthy individuals with no history of dysphagia or cancer who reviewed the DB with 1 of 2 interviewers. Strength of treatment preference was measured globally with a 7point Likert scale, and specifically on a 100 mm visual analog scale (VAS). RESULTS: The test group was 60% female, 62% African American, and 33% white (mean age 54). 42% had high school education or less. Using a 7-point Likert scale, 88% agreed strongly or very strongly that the DB was clear and presented adequate information to make a decision. 87% answered at least 80% correct responses on a knowledge exam of the risks and benefits of PEG and SEMS. Content validity was deemed adequate by expert review. Construct validity was deemed adequate by slope-analysis of change in treatment preference marked on a VAS when the probabilities of risk and benefit were varied. Criterion validity was tested by comparing treatment preferences on the VAS to a validated risk-behavior scale, the risk subtest of the Jackson Personality Inventory (Spearman coefficient=0.56, p=0.01). Internal consistency (test-retest at two weeks) for 20 subjects was excellent (Cronbach Alpha = 0.96). Inter-observer reliability for two different interviewers in the other 20 subjects was excellent (Cronbach Alpha = 0.85). There were no significant differences by race, age, sex, education or family history of cancer. CONCLUSION: The decision board appears to be a valid and reliable instrument for assessing patient preference of SEMS or PEG.
postpolypectomy bleeding. Celecoxib, a selective cyclooxygenase-2 inhibitor, is an effective analgesic without the antiplatelet effects of nonspecific NSAIDs. Aim: Evaluate the efficacy of celecoxib 200 mg daily in controlling symptoms of chronic pain and quality of life in patients with arthritis or musculoskeletal pain undergoing colonoscopy, while they are not taking their usual NSAIDs. Design: Prospective, randomized, placebo-controlled, double-blinded, 2-week study in patients with arthritis or musculoskeletal pain, requiring daily therapy with NSAIDs for $ 30 days prior to colonoscopy. Patients were randomized to celecoxib or placebo at Day 1, and colonoscopy was performed on Day 7. Rescue acetaminophen was permitted. Primary outcome measure was mean change in the Brief Pain Inventory-long form (BPI-lf) scores (0 = no pain, 10 = severe pain) at 1 and 2 weeks compared to baseline. Results: Celecoxib (n = 29) and placebo (n = 34) groups had similar baseline characteristics. Mean BPI scores were significantly improved with celecoxib compared with placebo as assessed by BPI Worst Pain (-1.24 6 1.98 vs 0.39 6 1.56; P = 0.007), Current Pain (-0.41 6 2.10 vs 0.78 6 1.70; P = 0.017), Average Pain (-0.69 6 1.48 vs 0.34 6 1.18; P = 0.004) and Mean Interference with Daily Activities (-0.99 6 1.86 vs 0.12 6 2.08; P = 0.033) scores. Repeated measures analysis, adjusting for influence of age and aspirin use, confirmed a favorable impact of celecoxib on BPI Worst Pain (P = 0.001), Current Pain (P = 0.026), and Average Pain (P = 0.004) scores. There was no significant difference between the groups in quality of life as measured by Torrance Feeling Thermometer, Global Pain Assessment, EuroQol-5D and Acute Short Form-12. Five patients withdrew from study by Day 7, all from the placebo group, with 3 stating severe pain while not taking their usual NSAIDs as cause for withdrawal. Conclusion: Celecoxib is effective in relieving arthritis pain in daily NSAID users discontinuing their therapy prior to colonoscopy without risk of bleeding. Celecoxib should be considered as an adjunctive therapy in the periprocedural management of patients with arthritis undergoing colonoscopy.
*S1591 Clinical Implications of the Extent of Invasion of T3 Esophageal Cancer as Determined by Endoscopic Ultrasound Tony E. Yusuf, Gavin C. Harewood, Jonathan E. Clain, Michael J. Levy, Kenneth K. Wang, Mark D. Topazian, Elizabeth Rajan Introduction: Endoscopic ultrasound (EUS) is an accurate imaging modality for local staging of esophageal cancer. Patients with advanced disease have poor outcome. The aim of this study was to determine if the depth of tumor invasion beyond the muscularis propria (MP) as determined by preoperative EUS could predict mortality in patients with T3 esophageal cancer. Methods: Records and images were reviewed for all patients with T3 esophageal cancer staged with EUS at our institution between 01/1999 and 10/2003, who subsequently underwent neoadjuvant chemoradiation and esophagectomy. EUS images were reviewed by five expert endosonographers blinded to patient outcome, and the tumors were classified as minimally invasive T3 disease (invasion <3mm beyond MP) or advanced T3 disease (invasion $ 3mm beyond MP). Results: Thirty-nine subjects (37 males and 2 females) with T3 esophageal cancer (36 adenocarcinomas and 3 squamous cell carcinomas) were identified; median age was 59 years (range, 41-78 years). The median tumor invasion beyond the MP as determined by EUS was 3mm (range, 0.5-11mm). Of these 39 patients, 17 had minimally invasive T3 disease and 22 had advanced disease. The median follow up duration for the minimally invasive group and the advanced disease group was 9 months (range, 5-24 months) and 14 months (range, 5-46 months) respectively. Death rates in the minimally invasive and advanced disease groups were 4/17 (24%) and 8/22 (36%) respectively. Adjusting for nodal status in a Cox proportional hazards model, minimally invasive T3 esophageal cancer was not associated with a statistically significant improvement in mortality: hazard ratio = 0.97 (95% C.I: 0.49-1.77), p = 0.92. Conclusions: The extent of invasion of T3 esophageal cancer beyond the muscularis propria as determined by EUS is not a significant predictor of increased mortality. Future prospective studies are required to more fully evaluate the role of EUS in this setting.
*S1590 Celecoxib Relieves Periprocedural Arthritis Pain in Patients Undergoing Colonoscopy Rohini Vij, Mark McCoy, Gurkirpal Singh, George Triadafilopoulos Background: Patients undergoing colonoscopy are usually instructed to discontinue nonsteroidal anti-inflammatory drugs (NSAIDs) to decrease the risk of
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VOLUME 59, NO. 5, 2004
*S1589 Development of a Decision Board to Elicit Patient Preferences for Palliation of Dysphagia due to Unresectable Esophageal Cancer Charles B. Evans, Leslie Nelson, Tamir Ben-Menachem PURPOSE: Patients with malignant dysphagia due to unresectable esophageal cancer are faced with the complex task of choosing between palliative options with very different risks and benefits. We developed and tested a decision board (DB) to aid patients in choosing between a self-expanding metal stent (SEMS) and a percutaneous endoscopic gastrostomy tube (PEG). METHODS: Elements to include in the DB were determined by 1) assessment of the efficacy and risks of the procedures by literature review and medical record review of patients receiving SEMS (n=102); and 2) assessment of individual experiences, concerns and expectations by interviewing patients with esophageal cancer and dysphagia, and healthcare professionals with expertise treating this population. Using these input, a 24 3 36 inch DB with columns of statements describing in lay terms the techniques, benefits and risks of SEMS and PEG was created, reviewed, and revised for content and clarity. The testing phase included forty healthy individuals with no history of dysphagia or cancer who reviewed the DB with 1 of 2 interviewers. Strength of treatment preference was measured globally with a 7point Likert scale, and specifically on a 100 mm visual analog scale (VAS). RESULTS: The test group was 60% female, 62% African American, and 33% white (mean age 54). 42% had high school education or less. Using a 7-point Likert scale, 88% agreed strongly or very strongly that the DB was clear and presented adequate information to make a decision. 87% answered at least 80% correct responses on a knowledge exam of the risks and benefits of PEG and SEMS. Content validity was deemed adequate by expert review. Construct validity was deemed adequate by slope-analysis of change in treatment preference marked on a VAS when the probabilities of risk and benefit were varied. Criterion validity was tested by comparing treatment preferences on the VAS to a validated risk-behavior scale, the risk subtest of the Jackson Personality Inventory (Spearman coefficient=0.56, p=0.01). Internal consistency (test-retest at two weeks) for 20 subjects was excellent (Cronbach Alpha = 0.96). Inter-observer reliability for two different interviewers in the other 20 subjects was excellent (Cronbach Alpha = 0.85). There were no significant differences by race, age, sex, education or family history of cancer. CONCLUSION: The decision board appears to be a valid and reliable instrument for assessing patient preference of SEMS or PEG.
postpolypectomy bleeding. Celecoxib, a selective cyclooxygenase-2 inhibitor, is an effective analgesic without the antiplatelet effects of nonspecific NSAIDs. Aim: Evaluate the efficacy of celecoxib 200 mg daily in controlling symptoms of chronic pain and quality of life in patients with arthritis or musculoskeletal pain undergoing colonoscopy, while they are not taking their usual NSAIDs. Design: Prospective, randomized, placebo-controlled, double-blinded, 2-week study in patients with arthritis or musculoskeletal pain, requiring daily therapy with NSAIDs for $ 30 days prior to colonoscopy. Patients were randomized to celecoxib or placebo at Day 1, and colonoscopy was performed on Day 7. Rescue acetaminophen was permitted. Primary outcome measure was mean change in the Brief Pain Inventory-long form (BPI-lf) scores (0 = no pain, 10 = severe pain) at 1 and 2 weeks compared to baseline. Results: Celecoxib (n = 29) and placebo (n = 34) groups had similar baseline characteristics. Mean BPI scores were significantly improved with celecoxib compared with placebo as assessed by BPI Worst Pain (-1.24 6 1.98 vs 0.39 6 1.56; P = 0.007), Current Pain (-0.41 6 2.10 vs 0.78 6 1.70; P = 0.017), Average Pain (-0.69 6 1.48 vs 0.34 6 1.18; P = 0.004) and Mean Interference with Daily Activities (-0.99 6 1.86 vs 0.12 6 2.08; P = 0.033) scores. Repeated measures analysis, adjusting for influence of age and aspirin use, confirmed a favorable impact of celecoxib on BPI Worst Pain (P = 0.001), Current Pain (P = 0.026), and Average Pain (P = 0.004) scores. There was no significant difference between the groups in quality of life as measured by Torrance Feeling Thermometer, Global Pain Assessment, EuroQol-5D and Acute Short Form-12. Five patients withdrew from study by Day 7, all from the placebo group, with 3 stating severe pain while not taking their usual NSAIDs as cause for withdrawal. Conclusion: Celecoxib is effective in relieving arthritis pain in daily NSAID users discontinuing their therapy prior to colonoscopy without risk of bleeding. Celecoxib should be considered as an adjunctive therapy in the periprocedural management of patients with arthritis undergoing colonoscopy.
*S1591 Clinical Implications of the Extent of Invasion of T3 Esophageal Cancer as Determined by Endoscopic Ultrasound Tony E. Yusuf, Gavin C. Harewood, Jonathan E. Clain, Michael J. Levy, Kenneth K. Wang, Mark D. Topazian, Elizabeth Rajan Introduction: Endoscopic ultrasound (EUS) is an accurate imaging modality for local staging of esophageal cancer. Patients with advanced disease have poor outcome. The aim of this study was to determine if the depth of tumor invasion beyond the muscularis propria (MP) as determined by preoperative EUS could predict mortality in patients with T3 esophageal cancer. Methods: Records and images were reviewed for all patients with T3 esophageal cancer staged with EUS at our institution between 01/1999 and 10/2003, who subsequently underwent neoadjuvant chemoradiation and esophagectomy. EUS images were reviewed by five expert endosonographers blinded to patient outcome, and the tumors were classified as minimally invasive T3 disease (invasion <3mm beyond MP) or advanced T3 disease (invasion $ 3mm beyond MP). Results: Thirty-nine subjects (37 males and 2 females) with T3 esophageal cancer (36 adenocarcinomas and 3 squamous cell carcinomas) were identified; median age was 59 years (range, 41-78 years). The median tumor invasion beyond the MP as determined by EUS was 3mm (range, 0.5-11mm). Of these 39 patients, 17 had minimally invasive T3 disease and 22 had advanced disease. The median follow up duration for the minimally invasive group and the advanced disease group was 9 months (range, 5-24 months) and 14 months (range, 5-46 months) respectively. Death rates in the minimally invasive and advanced disease groups were 4/17 (24%) and 8/22 (36%) respectively. Adjusting for nodal status in a Cox proportional hazards model, minimally invasive T3 esophageal cancer was not associated with a statistically significant improvement in mortality: hazard ratio = 0.97 (95% C.I: 0.49-1.77), p = 0.92. Conclusions: The extent of invasion of T3 esophageal cancer beyond the muscularis propria as determined by EUS is not a significant predictor of increased mortality. Future prospective studies are required to more fully evaluate the role of EUS in this setting.
*S1590 Celecoxib Relieves Periprocedural Arthritis Pain in Patients Undergoing Colonoscopy Rohini Vij, Mark McCoy, Gurkirpal Singh, George Triadafilopoulos Background: Patients undergoing colonoscopy are usually instructed to discontinue nonsteroidal anti-inflammatory drugs (NSAIDs) to decrease the risk of
P134
GASTROINTESTINAL ENDOSCOPY
VOLUME 59, NO. 5, 2004