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Mo1262 Classification of Patients by Using Factors Predictive of Intolerance to Transoral Esophagogastroduodenoscopy (EGD) and Identification of Patients for Whom TransNasal EGD May be of Particular Value
Abstracts
We sought systematic post-procedure follow-up data—patients were contacted directly by phone by trained research nurses 30 days after their procedure; a structured interview protocol was used to obtain patient-reported outcomes. Measures included no complications, minor complications (bleeding or pain not requiring primary care physician/emergency department review), moderate complications (bleeding or pain requiring primary care physician/emergency department review), and major complications (bleeding or pain requiring hospital admission, blood transfusion, perforation, surgery, death). Multiple logistic regression analyses were used to assess demographic, clinical and system factors associated with complications. Results: A total of 5475 colonoscopies were performed between 2008-2010 (male 51%; mean [SD] age 57.8 [15.3]). 307 (5.6%) patients were unable to be contacted despite 3 separate attempts. Overall, 432 (8%) patients reported a complication after colonoscopy. 313 (6%) patients had minor complications, 72 (1.4%) patients had moderate complications and 47 (0.9%) patients had major complications. Major complications requiring hospital admission included pain (n⫽27, 0.5%), bleeding (n⫽24, 0.5%), blood transfusion (n⫽6, 0.1%), perforation (n⫽3, 0.06%) and surgery (3, 0.06%). There were no deaths attributable to colonoscopy. A higher rate of complications was associated with older age (p⫽0.047), polypectomy (p⬍0.001) and the use of air insufflation (p⫽0.003), but not influenced by sex, anesthesiology support, GI fellow involvement and colonoscopist. Conclusions: Systematic telephone contact with patients after colonoscopy achieved high rates of follow-up. Using this method, the rate of complications following colonoscopy in a large teaching hospital endoscopy unit is consistent with published literature. Further validation of this approach for evaluating colonoscopy complication rates is required. A) The incidence of patient reported complications according to severity at 30 days Complications, n(%) Pain Bleeding Blood transfusion Perforation Surgery Death Total
Nil
4736 (92)
Minor
Moderate
Major
Total
234 (4.5) 98 (1.9)
57 (1.1) 20 (0.4)
313 (6)
72 (1.4)
27 (0.5) 24 (0.5) 6 (0.1) 3 (0.06) 3 (0.06) 0 (0) 47 (0.9)
318 (6.2) 142 (2.7) 6 (0.1) 3 (0.06) 3 (0.06) 0 (0) 432 (8)
B) Multiple logistic regression analyses predicting overall complications (any severity) at 30 days
Age Male sex Anesthesiology support GI fellow involvement Polypectomy CO2 insufflation
ORⴱ
P value
95% CI
0.92 1.15 1.12 0.97 1.63 0.59
0.047 0.256 0.55 0.86 ⬍0.001 0.003
0.86 to 1.00 0.90 to 1.45 0.78 to 1.60 0.72 to 1.32 1.21 to 1.99 0.51 to 0.96
ⴱ Odds Ratio (OR) adjusted for colonoscopist.
Mo1262 Classification of Patients by Using Factors Predictive of Intolerance to Transoral Esophagogastroduodenoscopy (EGD) and Identification of Patients for Whom TransNasal EGD May be of Particular Value Kazumasa Miyake, Nobue Ueki*, Wataru Sato, Hiroyuki Nagoya, Yasuhiro Kodaka, Tomotaka Shindo, Masafumi Kusunoki, Tetsuro Kawagoe, Seiji Futagami, Katya Gudis, Choitsu Sakamoto Gastroenterology, Nippon Medical School, Tokyo, Japan Background and aims: Esophagogastroduodenoscopy (EGD) is widely used for detecting upper gastrointestinal disease and early gastric cancer. Thus, the safety and tolerability of EGD are important issues. However, transoral EGD (TO-EGD) can evoke anxiety, feelings of vulnerability, embarrassment, and discomfort. These concerns decrease patient compliance, making execution of EGD more difficult. In many countries, TO-EGD is performed using conscious sedation. Although sedation improves intolerance of patients for TO-EGD, it predisposes to adverse effects and increases the costs for EGD. On the other hand, transnasal EGD (TN-EGD), narrow-diameter endoscopes introduced through the nose were developed to reduce patient’s concerns, and avoid the cost and risks associated with sediation. Higher-resolution EGD is desirable in detailed examination for minute lesions. But the reduction of the diameter in TN-EGD results in inferior image quality and smaller biopsy size, and renders the procedure more stressful. Therefore, we investigated the predictive factors for detecting patients’ intolerance to TO-EGD, to raise the value of choosing TN-EGD. Methods: Subjects of this prospective cohort study comprised consecutive outpatients who underwent EGD at our hospital from Aug. to Dec. 2010. A total of 722
outpatients (387 men, 63.1 ⫾ 0.5 years; TO-EGD cases, 630; TN-EGD cases, 92) who met our selection criteria were analyzed. Step 1: Investigation of factors expected to predict the severity of TO-EGD-induced distress, using uni- and multi-variate analylsis. Step 2: Classification of patients as mild (total points ⬍3) or severe (total points 3 or 4) using the four independent predictive factors of age ⬍ 65, gender (female), marital state (single), and anxiety toward TO-EGD (scored 1 point per factor) as identified from Step 1; the severity of TO- and TNEGD-induced distress was compared in each class. The severity of EGD-induced distress was estimated using a visual analog scale (VAS; range 0-100) and the change (⌬) of rate-pressure product (RPP; pulse⫻BP/100) as subjective and objective indices, respectively. Results: Severity of TO-EGD distress was higher than TN-EGD distress in the severe class, but not the mild class (VAS, TO vs TN: severe class, 58.4 ⫾ 2.6 vs 36.6 ⫾ 4.0, p⬍ 0.01; mild class, 33.1 ⫾ 1.1 vs 30.8 ⫾ 3.2, NS). Surprisingly, the delta RPP objective index also showed that TO-EGD distress was higher than TN-EGD distress in the severe class, but not the mild class (⌬ RPP, TO vs TN: severe class, 1259.2 ⫾ 272.8 vs ⫺110.241 ⫾ 374.7, p⬍ 0.05; mild class, 1088.6 ⫾ 125.0 vs 649.7 ⫾ 359.4, NS). Conclusion: The patient classification described in this study is useful for identifying patients intolerant to TO-EGD and for whom TN-EGD may hold particular value.
Mo1263 CRP, but Not CDAI is Associated With Enterocolonic Mucosal Healing in Crohn’s Disease Treated With Infliximab; A Single Center Cohort Study Atsuo Maemoto*, Shigeru Furukawa, Fumika Orii, Toshifumi Ashida Inflammatory Bowel Disease Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan Background and Aim: The concept of ‘mucosal healing (MH)’ in the assessment of disease activity for Crohn’s disease (CD) is regarded as a predictor for longterm good prognosis, recently. To identify the indicator of MH, we analyzed the relationship between the endoscopic/radiological findings and symptomatic/ serological markers in the patient cohort who received induction and scheduled maintenance administration of Infliximab (IFX) in our IBD center. Patients and Methods: Eighty-four CD patients were enrolled in this study. Initial response to IFX was evaluated at week 10 after the initial administration by the criteria based on the clinical symptoms. Crohn’s disease activity index (CDAI), and other serological tests including C-reactive protein (CRP) were assessed at every visit of IFX infusion. Enterocolonic lesions of CD were evaluated by annual endoscopy, X-ray small bowel series, or by combination of both methods. MH is defined as the complete disappearance of ulcerative lesions in these examinations. Results: In this cohort, 92.9% (77/84) became responder to IFX (5mg/kg) administration within week 10, whereas 7.1% (6/84) of the patients were primary nonresponders. All primary responders were followed by scheduled administration of IFX (5mg/kg). During of follow up periods (median 26 months), 4 patients discontinued IFX administration due to the major abdominal surgery and severe adverse events. For 16 patients rescue strategies (dose escalation to 10mg/kg for 7; shortening of the interval for 3, and both for 6) were required due to the loss of response. The other 75.3% (58/77) of the patients had sustained clinical benefit at the end of follow up. Percentages of CDAI⬍150, and CRP ⬍0.3 mg/dl were summarized in Table 1. MH was achieved in 49.0% (22/49), 52.1% (12/23), and 50.0% (7/14) of the patients tested at year 1, 2 and 3 respectively. Among the patients with MH at year 1, 100% (22/22) showed CDAI⬍150, and 81.8% (18/ 22) showed CRP⬍0.3. In 88.9% (24/27) patients without MH at year 1 also showed CDAI⬍150. In contrast to CDAI, only 48.1% (13/27) of the MH (-) patients showed CRP⬍0.3. Conclusion: In our single center cohort, maintenance administration of IFX (5mg/kg) was effective for keeping symptomatic remission for 2-3 years. However, MH was observed only in a half of these patients. Negative CRP is strongly associated with MH, so we should consider the dose escalation or shortening intervals of IFX, or other alternative treatments, even for the responder patients with positive CRP. Table 1. CDAI⬍150 CRP⬍0.3 mg/dl
Week 10
Week 48
Week 94
Week 142
Week 182
92.8% (77/84) 81.9% (68/83)
93.8% (61/65) 62.7% (42/67)
93.9% (46/49) 62.0% (31/50)
86.0% (31/36) 72.2% (26/36)
66.7% (4/6) 62.5% (5/8)
Mo1264 Is Second-Look Endoscopy Necessary After Endoscopic Submucosal Dissection of Gastric Neoplasia? A Preminary Result Hyun-Soo Kim*, Hyo Keun Jeon, Il Young Lee, Ho Yoel Ryu, Hong Jun Park, so Yeon Park, Bo Ra Kim, Jin Heon Hong, Ki Won Jo, Jae Woo Kim Yonsei Univ. Wonju College of Medicine, Wonju, Republic of Korea Background & Aim: A second-look endoscopy (SL) is routinely performed on the next day after endoscopic submucosal dissection (ESD), fearing the risk of postESD bleeding. However, performing a second-look endoscopy in patient without
AB369 GASTROINTESTINAL ENDOSCOPY Volume 75, No. 4S : 2012
www.giejournal.org
We sought systematic post-procedure follow-up data—patients were contacted directly by phone by trained research nurses 30 days after their procedure; a structured interview protocol was used to obtain patient-reported outcomes. Measures included no complications, minor complications (bleeding or pain not requiring primary care physician/emergency department review), moderate complications (bleeding or pain requiring primary care physician/emergency department review), and major complications (bleeding or pain requiring hospital admission, blood transfusion, perforation, surgery, death). Multiple logistic regression analyses were used to assess demographic, clinical and system factors associated with complications. Results: A total of 5475 colonoscopies were performed between 2008-2010 (male 51%; mean [SD] age 57.8 [15.3]). 307 (5.6%) patients were unable to be contacted despite 3 separate attempts. Overall, 432 (8%) patients reported a complication after colonoscopy. 313 (6%) patients had minor complications, 72 (1.4%) patients had moderate complications and 47 (0.9%) patients had major complications. Major complications requiring hospital admission included pain (n⫽27, 0.5%), bleeding (n⫽24, 0.5%), blood transfusion (n⫽6, 0.1%), perforation (n⫽3, 0.06%) and surgery (3, 0.06%). There were no deaths attributable to colonoscopy. A higher rate of complications was associated with older age (p⫽0.047), polypectomy (p⬍0.001) and the use of air insufflation (p⫽0.003), but not influenced by sex, anesthesiology support, GI fellow involvement and colonoscopist. Conclusions: Systematic telephone contact with patients after colonoscopy achieved high rates of follow-up. Using this method, the rate of complications following colonoscopy in a large teaching hospital endoscopy unit is consistent with published literature. Further validation of this approach for evaluating colonoscopy complication rates is required. A) The incidence of patient reported complications according to severity at 30 days Complications, n(%) Pain Bleeding Blood transfusion Perforation Surgery Death Total
Nil
4736 (92)
Minor
Moderate
Major
Total
234 (4.5) 98 (1.9)
57 (1.1) 20 (0.4)
313 (6)
72 (1.4)
27 (0.5) 24 (0.5) 6 (0.1) 3 (0.06) 3 (0.06) 0 (0) 47 (0.9)
318 (6.2) 142 (2.7) 6 (0.1) 3 (0.06) 3 (0.06) 0 (0) 432 (8)
B) Multiple logistic regression analyses predicting overall complications (any severity) at 30 days
Age Male sex Anesthesiology support GI fellow involvement Polypectomy CO2 insufflation
ORⴱ
P value
95% CI
0.92 1.15 1.12 0.97 1.63 0.59
0.047 0.256 0.55 0.86 ⬍0.001 0.003
0.86 to 1.00 0.90 to 1.45 0.78 to 1.60 0.72 to 1.32 1.21 to 1.99 0.51 to 0.96
ⴱ Odds Ratio (OR) adjusted for colonoscopist.
Mo1262 Classification of Patients by Using Factors Predictive of Intolerance to Transoral Esophagogastroduodenoscopy (EGD) and Identification of Patients for Whom TransNasal EGD May be of Particular Value Kazumasa Miyake, Nobue Ueki*, Wataru Sato, Hiroyuki Nagoya, Yasuhiro Kodaka, Tomotaka Shindo, Masafumi Kusunoki, Tetsuro Kawagoe, Seiji Futagami, Katya Gudis, Choitsu Sakamoto Gastroenterology, Nippon Medical School, Tokyo, Japan Background and aims: Esophagogastroduodenoscopy (EGD) is widely used for detecting upper gastrointestinal disease and early gastric cancer. Thus, the safety and tolerability of EGD are important issues. However, transoral EGD (TO-EGD) can evoke anxiety, feelings of vulnerability, embarrassment, and discomfort. These concerns decrease patient compliance, making execution of EGD more difficult. In many countries, TO-EGD is performed using conscious sedation. Although sedation improves intolerance of patients for TO-EGD, it predisposes to adverse effects and increases the costs for EGD. On the other hand, transnasal EGD (TN-EGD), narrow-diameter endoscopes introduced through the nose were developed to reduce patient’s concerns, and avoid the cost and risks associated with sediation. Higher-resolution EGD is desirable in detailed examination for minute lesions. But the reduction of the diameter in TN-EGD results in inferior image quality and smaller biopsy size, and renders the procedure more stressful. Therefore, we investigated the predictive factors for detecting patients’ intolerance to TO-EGD, to raise the value of choosing TN-EGD. Methods: Subjects of this prospective cohort study comprised consecutive outpatients who underwent EGD at our hospital from Aug. to Dec. 2010. A total of 722
outpatients (387 men, 63.1 ⫾ 0.5 years; TO-EGD cases, 630; TN-EGD cases, 92) who met our selection criteria were analyzed. Step 1: Investigation of factors expected to predict the severity of TO-EGD-induced distress, using uni- and multi-variate analylsis. Step 2: Classification of patients as mild (total points ⬍3) or severe (total points 3 or 4) using the four independent predictive factors of age ⬍ 65, gender (female), marital state (single), and anxiety toward TO-EGD (scored 1 point per factor) as identified from Step 1; the severity of TO- and TNEGD-induced distress was compared in each class. The severity of EGD-induced distress was estimated using a visual analog scale (VAS; range 0-100) and the change (⌬) of rate-pressure product (RPP; pulse⫻BP/100) as subjective and objective indices, respectively. Results: Severity of TO-EGD distress was higher than TN-EGD distress in the severe class, but not the mild class (VAS, TO vs TN: severe class, 58.4 ⫾ 2.6 vs 36.6 ⫾ 4.0, p⬍ 0.01; mild class, 33.1 ⫾ 1.1 vs 30.8 ⫾ 3.2, NS). Surprisingly, the delta RPP objective index also showed that TO-EGD distress was higher than TN-EGD distress in the severe class, but not the mild class (⌬ RPP, TO vs TN: severe class, 1259.2 ⫾ 272.8 vs ⫺110.241 ⫾ 374.7, p⬍ 0.05; mild class, 1088.6 ⫾ 125.0 vs 649.7 ⫾ 359.4, NS). Conclusion: The patient classification described in this study is useful for identifying patients intolerant to TO-EGD and for whom TN-EGD may hold particular value.
Mo1263 CRP, but Not CDAI is Associated With Enterocolonic Mucosal Healing in Crohn’s Disease Treated With Infliximab; A Single Center Cohort Study Atsuo Maemoto*, Shigeru Furukawa, Fumika Orii, Toshifumi Ashida Inflammatory Bowel Disease Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan Background and Aim: The concept of ‘mucosal healing (MH)’ in the assessment of disease activity for Crohn’s disease (CD) is regarded as a predictor for longterm good prognosis, recently. To identify the indicator of MH, we analyzed the relationship between the endoscopic/radiological findings and symptomatic/ serological markers in the patient cohort who received induction and scheduled maintenance administration of Infliximab (IFX) in our IBD center. Patients and Methods: Eighty-four CD patients were enrolled in this study. Initial response to IFX was evaluated at week 10 after the initial administration by the criteria based on the clinical symptoms. Crohn’s disease activity index (CDAI), and other serological tests including C-reactive protein (CRP) were assessed at every visit of IFX infusion. Enterocolonic lesions of CD were evaluated by annual endoscopy, X-ray small bowel series, or by combination of both methods. MH is defined as the complete disappearance of ulcerative lesions in these examinations. Results: In this cohort, 92.9% (77/84) became responder to IFX (5mg/kg) administration within week 10, whereas 7.1% (6/84) of the patients were primary nonresponders. All primary responders were followed by scheduled administration of IFX (5mg/kg). During of follow up periods (median 26 months), 4 patients discontinued IFX administration due to the major abdominal surgery and severe adverse events. For 16 patients rescue strategies (dose escalation to 10mg/kg for 7; shortening of the interval for 3, and both for 6) were required due to the loss of response. The other 75.3% (58/77) of the patients had sustained clinical benefit at the end of follow up. Percentages of CDAI⬍150, and CRP ⬍0.3 mg/dl were summarized in Table 1. MH was achieved in 49.0% (22/49), 52.1% (12/23), and 50.0% (7/14) of the patients tested at year 1, 2 and 3 respectively. Among the patients with MH at year 1, 100% (22/22) showed CDAI⬍150, and 81.8% (18/ 22) showed CRP⬍0.3. In 88.9% (24/27) patients without MH at year 1 also showed CDAI⬍150. In contrast to CDAI, only 48.1% (13/27) of the MH (-) patients showed CRP⬍0.3. Conclusion: In our single center cohort, maintenance administration of IFX (5mg/kg) was effective for keeping symptomatic remission for 2-3 years. However, MH was observed only in a half of these patients. Negative CRP is strongly associated with MH, so we should consider the dose escalation or shortening intervals of IFX, or other alternative treatments, even for the responder patients with positive CRP. Table 1. CDAI⬍150 CRP⬍0.3 mg/dl
Week 10
Week 48
Week 94
Week 142
Week 182
92.8% (77/84) 81.9% (68/83)
93.8% (61/65) 62.7% (42/67)
93.9% (46/49) 62.0% (31/50)
86.0% (31/36) 72.2% (26/36)
66.7% (4/6) 62.5% (5/8)
Mo1264 Is Second-Look Endoscopy Necessary After Endoscopic Submucosal Dissection of Gastric Neoplasia? A Preminary Result Hyun-Soo Kim*, Hyo Keun Jeon, Il Young Lee, Ho Yoel Ryu, Hong Jun Park, so Yeon Park, Bo Ra Kim, Jin Heon Hong, Ki Won Jo, Jae Woo Kim Yonsei Univ. Wonju College of Medicine, Wonju, Republic of Korea Background & Aim: A second-look endoscopy (SL) is routinely performed on the next day after endoscopic submucosal dissection (ESD), fearing the risk of postESD bleeding. However, performing a second-look endoscopy in patient without
AB369 GASTROINTESTINAL ENDOSCOPY Volume 75, No. 4S : 2012
www.giejournal.org