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Sa1654 Comparison of Cost-Effectiveness of Three Treatments (Rabeprazole With Rebamipide Combination Therapy; Lansoprazole With Rebamipide Combination Therapy; Rabeprazole Monotherapy) for Gastric Ulcers Post-ESD
Abstracts
Sa1653 Comparative Clinical Study of Patients With Upper Non-Variceal Gastrointestinal Bleeding From Peptic Ulcers and Dieulafoy Lesions Genaro Vazquez-Elizondo, Jose A Gonzalez, Aldo A. Garza, Hector J. Maldonado Centro Regional para el Estudio de las Enfermedades Digestivas, Hospital Universitario de Nuevo León, Monterrey, Mexico Background: To our knowledge, no clinical study comparing the clinical course, complications and mortality of non-variceal upper gastrointestinal bleeding form Dieulafoy lesions (DL) and peptic ulcers (PU) had been reported. Aim. To compare the demographic data, clinical evolution, complications and mortality between patients with bleeding from Dieulafoy lesions and peptic ulcer. Methods: From a previously collected database (2000 to 2009) we identified all consecutive patients admitted with diagnosis of upper gastrointestinal bleeding from DL and PU. We studied demographic data, clinical features, endoscopic findings and treatment, length of hospital stay, complications and mortality. Variables were expressed as mean and standard deviation and descriptive and comparative statistics were used for comparisons. Results: Of 1067 patients with non-variceal upper gastrointestinal bleeding, 593 patients had PU; gastric in 308 (28.9%) and duodenal in 240 (22.5%) and 22 (2.1%) patients had a DL. Table 1 shows main results; we found a significant differences on regard of age, endoscopy timing, presence of bright red blood hematemesis, rebleeding and bleeding related mortality. When analyzing dead patients in DL group (4/22 patients), 3 had in hospital bleeding, 3 rebleed, 3 died from hipovolemic shock and one for sepsis. Conclusions: Patients with DL were younger and more frequently presents with bright red blood hematemesis than PU patients. Patients with in-hospital bleeding and DL had a higher bleeding related mortality. Table 1. Demographic, clinical, endoscopic, complications and prognostic results Variable Age(years) Male gender Number of comorbidities NSAID use Alcohol use Tobacco use Endoscopy time ⬍ 12 hrs In-hospital bleeding Hypovolemic shock Red bright hematemesis Admission hemoglobin (mg/dL) Blood transfusions Number of blood units Admission BUN (mg/dL) Combined endoscopic treatment PPI treatment Rebleeding Surgical treatment Mortality Bleeding related mortality Non-bleeding related mortality In-hospital stay (days)
DL n ⴝ 22 n (%)/ Mean ⴞ SD
PUD n ⴝ 593 n (%)/ Mean ⴞ SD
p
51.8 ⫾ 18.8 15 (68.2) 1.3 ⫾ 0.7 10 (45.5) 9 (40.9) 8 (36.4) 14 (63.6) 6 (27.3) 7 (31.8) 11 (50) 7.9 ⫾ 3.2 18 (81.8) 4.4 ⫾ 3.2 31.5 ⫾ 16.7 17 (77.3) 12 (54.5) 4 (18.2) 1 (4.5) 4 (18.2) 3 (13.6) 1 (4.5) 10.4 ⫾ 11.9
61.2 ⫾ 17.9 386 (65.1) 1.6 ⫾ 0.7 189 (31.9) 244 (41.1) 200 (33.7) 203 (34.2) 61 (10.3) 169 (28.5) 159 (26.8) 8.7 ⫾ 3.1 410 (69.1) 3.1 ⫾ 1.9 44.4 ⫾ 37.8 190 (68.3) 327 (55.1) 27 (4.6) 11 (1.9) 62 (10.5) 21 (3.5) 41 (6.9) 6.6 ⫾ 7.7
0.026 NS NS NS NS NS 0.006 0.024 NS 0.026 NS NS NS NS NS NS 0.020 NS NS 0.049 NS NS
Sa1654 Comparison of Cost-Effectiveness of Three Treatments (Rabeprazole With Rebamipide Combination Therapy; Lansoprazole With Rebamipide Combination Therapy; Rabeprazole Monotherapy) for Gastric Ulcers Post-ESD Masakatsu Nakamura1, Tomiyasu Arisawa2, Tomoyuki Shibata1, Tomomitsu Tahara1, Masaaki Okubo1, Hisakazu Shiroeda2, Tomoki Fukuyama2, Kazuaki Ozaki2, Toshimi Otsuka2, Ichiro Hirata1 1 Gastroenterology, Fujita Health University school of medicine, Toyoake, Japan; 2Department of Gastroenterology, Kanazawa Medical University, Uchinada, Japan [AIMS] While ESD is useful in treating early gastric cancer, removing major tumors often leads to large ulcers. PPI monotherapy for 56 days is widely used to treat gastric ulcers post-ESD, but reports suggest its inadequacy for larger ulcers. With potent PPI activity, rabeprazole is often used to treat larger ulcers post-ESD, but at its full dose is among the most costly of PPIs. In Study I, we compared ulcer healing and ulcer reductions for a rabeprazole monotherapy group and a combination therapy group of rabeprazole ⫹ rebamipide (a less
costly therapy) among patients who underwent ESD involving large tumors. A second study, Study II, compared these results to results obtained with a combination therapy group of lansoprazole ⫹ rebamipide, a still cheaper option. [METHODS] Study I examined post-ESD patients randomly assigned to either of two groups: a Rabe group treated only with rabeprazole for 8 weeks and a Rabe⫹reba group treated with rabeprazole for the first 4 weeks and with rebamipide for all 8 weeks. We compared healing and ratio of ulcer reductions at the 1st, 7th, 28th, and 56th day post-ESD. Study II compared these results to results for a third group treated with lansoprazole for the first 4 weeks and with rebamipide for all 8 weeks (Lanso⫹reba). The Ethics Committee of Fujita Health University School of Medicine approved the study protocol. We obtained written informed consent from all subjects. [RESULTS] Study 1 enrolled 34 patients for the Rabe group and 33 patients for the Rabe⫹reba group. No differences were observed in healing at the 56th day post-ESD. The ratio of ulcers was significantly reduced in the Rabe⫹reba group (ANOVA: p ⫽ 0.0368). The per patient treatment cost was 18,917 yen ($230 US) in the Rabe group and 12,709 yen ($154 US) in the Rabe⫹reba group, a difference of 6,208 yen ($75.4 US), making Rabe⫹reba more cost-effective. Study II enrolled 39 patients for a Lanso⫹reba group. On the 56th day, no significant differences were observed in healing or in ulcer reduction ratios between the Rabe⫹reba group and the Lanso⫹reba group (ANOVA: p ⫽ 0.5039). Per patient cost was 7,445 yen ($90.4 US) in the Lanso⫹reba group, 11,472 yen ($139.3 US) less than for the Rabe group. Given identical results, the Lanso⫹reba group was most cost-effective. [CONCLUSIONS] Combination therapy of rabeprazole for 4 weeks with rebamipide for 8 weeks achieved effects equal to rabeprazole monotherapy, making short-term use of rabeprazole with rebamipide a cost-effective therapy option. Combination therapy of lansoprazole for 4 weeks and rebamipide for 8 weeks was equally effective. No differences were observed among the three groups. Thus, combination therapy of lansoprazole for 4 weeks with rebamipide for 8 weeks is the most cost-effective therapy for gastric ulcers post-ESD.
Sa1655 Clinical Long-Term Prognosis of Endoscopic Submucosal Dissection for Early Gastric Cancer Masami Nakatani, Hirohisa Machida, Kazunari Tominaga, Hiroaki Minamino, Yasuaki Nagami, Satoshi Sugimori, Natsuhiko Kameda, Hirotoshi Okazaki, Hirokazu Yamagami, Tetsuya Tanigawa, Kenji Watanabe, Toshio Watanabe, Yasuhiro Fujiwara, Tetsuo Arakawa Osaka city university Graduate school of Medicine, Osaka, Japan Background and Aims: Endoscopic submucosal dissection (ESD) is one of curative surgical procedure for early gastric cancer (EGC) in order to obtain a precise pathological examination. Although both lymphovascular involvement and invasion depth of the cancer are critical factors for a prognosis, the effect of these risk factors have not been elucidated. The aim of this study is to evaluate the clinical outcomes and long-term efficacy of ESD for EGC. Patients and Methods: A total of 208 patients with 226 tumors from November 2007 underwent ESD treatment. On the basis of the pathological findings (lymphovascular involvement and invasion depth of cancer) after the resection, the tumors without lymphovascular involvement or massive invasion were assigned to two groups: EGC with average risk for a recurrence (group A: intramucosal tumors less than 20 mm in diameter without ulcerative change) and EGC with moderate risk for a recurrence (group B: intramucosal tumors with ulcerative change less than 30 mm in diameter, tumors less than 30 mm in diameter with slight submucosal invasion, or undifferentiated intramucosal cancer less than 20 mm in diameter). All patients received periodic endoscopic follow-up and enhanced CT for metastatic surveys for at least 3 years. As outcome measures, en bloc resection rate, curative rate (curative defined as en bloc resection and cancer free margin), and 3-year disease-free survival rate. Results: A total of 184 patients (88.4%) were followed-up completely, with a mean observation period of 3.8 (1.4-7.2) years. Subsequently, 199 tumors were assigned to 2 groups; 109 tumors in group A and 90 tumors in group B. En bloc resection rates were 98% and 97%, and curative resection rates were 96% and 89% in group A and B. Curative resection was not achieved in 4 and 10 tumors in group A and B, because of piecemeal resection/ positive or indistinct for lateral margin for the respective tumor (2/2 and 3/7). In cases of lateral margin positive, ESD was performed additionally, patients with indistinct margin were, however, followed-up endoscopically. In long-term results, lymph node or distant metastasis were not detected on CT scan in all patients, but local recurrence was detected one patient in each group at 26 months (group A) and at 6 months (group B) later. For the recurrence, salvage surgery revealed no lymph node metastasis. Subsequently, the disease-free survival rate was 100% in both groups during the follow-up period. Conclusions: ESD might be a curative procedure to promise good prognosis for EGC with average- and moderate-risk after exclusion for the lymphovascular involvement followed by a precise evaluation for the invasion depth of cancer.
AB236 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 4S : 2011
www.giejournal.org
Sa1653 Comparative Clinical Study of Patients With Upper Non-Variceal Gastrointestinal Bleeding From Peptic Ulcers and Dieulafoy Lesions Genaro Vazquez-Elizondo, Jose A Gonzalez, Aldo A. Garza, Hector J. Maldonado Centro Regional para el Estudio de las Enfermedades Digestivas, Hospital Universitario de Nuevo León, Monterrey, Mexico Background: To our knowledge, no clinical study comparing the clinical course, complications and mortality of non-variceal upper gastrointestinal bleeding form Dieulafoy lesions (DL) and peptic ulcers (PU) had been reported. Aim. To compare the demographic data, clinical evolution, complications and mortality between patients with bleeding from Dieulafoy lesions and peptic ulcer. Methods: From a previously collected database (2000 to 2009) we identified all consecutive patients admitted with diagnosis of upper gastrointestinal bleeding from DL and PU. We studied demographic data, clinical features, endoscopic findings and treatment, length of hospital stay, complications and mortality. Variables were expressed as mean and standard deviation and descriptive and comparative statistics were used for comparisons. Results: Of 1067 patients with non-variceal upper gastrointestinal bleeding, 593 patients had PU; gastric in 308 (28.9%) and duodenal in 240 (22.5%) and 22 (2.1%) patients had a DL. Table 1 shows main results; we found a significant differences on regard of age, endoscopy timing, presence of bright red blood hematemesis, rebleeding and bleeding related mortality. When analyzing dead patients in DL group (4/22 patients), 3 had in hospital bleeding, 3 rebleed, 3 died from hipovolemic shock and one for sepsis. Conclusions: Patients with DL were younger and more frequently presents with bright red blood hematemesis than PU patients. Patients with in-hospital bleeding and DL had a higher bleeding related mortality. Table 1. Demographic, clinical, endoscopic, complications and prognostic results Variable Age(years) Male gender Number of comorbidities NSAID use Alcohol use Tobacco use Endoscopy time ⬍ 12 hrs In-hospital bleeding Hypovolemic shock Red bright hematemesis Admission hemoglobin (mg/dL) Blood transfusions Number of blood units Admission BUN (mg/dL) Combined endoscopic treatment PPI treatment Rebleeding Surgical treatment Mortality Bleeding related mortality Non-bleeding related mortality In-hospital stay (days)
DL n ⴝ 22 n (%)/ Mean ⴞ SD
PUD n ⴝ 593 n (%)/ Mean ⴞ SD
p
51.8 ⫾ 18.8 15 (68.2) 1.3 ⫾ 0.7 10 (45.5) 9 (40.9) 8 (36.4) 14 (63.6) 6 (27.3) 7 (31.8) 11 (50) 7.9 ⫾ 3.2 18 (81.8) 4.4 ⫾ 3.2 31.5 ⫾ 16.7 17 (77.3) 12 (54.5) 4 (18.2) 1 (4.5) 4 (18.2) 3 (13.6) 1 (4.5) 10.4 ⫾ 11.9
61.2 ⫾ 17.9 386 (65.1) 1.6 ⫾ 0.7 189 (31.9) 244 (41.1) 200 (33.7) 203 (34.2) 61 (10.3) 169 (28.5) 159 (26.8) 8.7 ⫾ 3.1 410 (69.1) 3.1 ⫾ 1.9 44.4 ⫾ 37.8 190 (68.3) 327 (55.1) 27 (4.6) 11 (1.9) 62 (10.5) 21 (3.5) 41 (6.9) 6.6 ⫾ 7.7
0.026 NS NS NS NS NS 0.006 0.024 NS 0.026 NS NS NS NS NS NS 0.020 NS NS 0.049 NS NS
Sa1654 Comparison of Cost-Effectiveness of Three Treatments (Rabeprazole With Rebamipide Combination Therapy; Lansoprazole With Rebamipide Combination Therapy; Rabeprazole Monotherapy) for Gastric Ulcers Post-ESD Masakatsu Nakamura1, Tomiyasu Arisawa2, Tomoyuki Shibata1, Tomomitsu Tahara1, Masaaki Okubo1, Hisakazu Shiroeda2, Tomoki Fukuyama2, Kazuaki Ozaki2, Toshimi Otsuka2, Ichiro Hirata1 1 Gastroenterology, Fujita Health University school of medicine, Toyoake, Japan; 2Department of Gastroenterology, Kanazawa Medical University, Uchinada, Japan [AIMS] While ESD is useful in treating early gastric cancer, removing major tumors often leads to large ulcers. PPI monotherapy for 56 days is widely used to treat gastric ulcers post-ESD, but reports suggest its inadequacy for larger ulcers. With potent PPI activity, rabeprazole is often used to treat larger ulcers post-ESD, but at its full dose is among the most costly of PPIs. In Study I, we compared ulcer healing and ulcer reductions for a rabeprazole monotherapy group and a combination therapy group of rabeprazole ⫹ rebamipide (a less
costly therapy) among patients who underwent ESD involving large tumors. A second study, Study II, compared these results to results obtained with a combination therapy group of lansoprazole ⫹ rebamipide, a still cheaper option. [METHODS] Study I examined post-ESD patients randomly assigned to either of two groups: a Rabe group treated only with rabeprazole for 8 weeks and a Rabe⫹reba group treated with rabeprazole for the first 4 weeks and with rebamipide for all 8 weeks. We compared healing and ratio of ulcer reductions at the 1st, 7th, 28th, and 56th day post-ESD. Study II compared these results to results for a third group treated with lansoprazole for the first 4 weeks and with rebamipide for all 8 weeks (Lanso⫹reba). The Ethics Committee of Fujita Health University School of Medicine approved the study protocol. We obtained written informed consent from all subjects. [RESULTS] Study 1 enrolled 34 patients for the Rabe group and 33 patients for the Rabe⫹reba group. No differences were observed in healing at the 56th day post-ESD. The ratio of ulcers was significantly reduced in the Rabe⫹reba group (ANOVA: p ⫽ 0.0368). The per patient treatment cost was 18,917 yen ($230 US) in the Rabe group and 12,709 yen ($154 US) in the Rabe⫹reba group, a difference of 6,208 yen ($75.4 US), making Rabe⫹reba more cost-effective. Study II enrolled 39 patients for a Lanso⫹reba group. On the 56th day, no significant differences were observed in healing or in ulcer reduction ratios between the Rabe⫹reba group and the Lanso⫹reba group (ANOVA: p ⫽ 0.5039). Per patient cost was 7,445 yen ($90.4 US) in the Lanso⫹reba group, 11,472 yen ($139.3 US) less than for the Rabe group. Given identical results, the Lanso⫹reba group was most cost-effective. [CONCLUSIONS] Combination therapy of rabeprazole for 4 weeks with rebamipide for 8 weeks achieved effects equal to rabeprazole monotherapy, making short-term use of rabeprazole with rebamipide a cost-effective therapy option. Combination therapy of lansoprazole for 4 weeks and rebamipide for 8 weeks was equally effective. No differences were observed among the three groups. Thus, combination therapy of lansoprazole for 4 weeks with rebamipide for 8 weeks is the most cost-effective therapy for gastric ulcers post-ESD.
Sa1655 Clinical Long-Term Prognosis of Endoscopic Submucosal Dissection for Early Gastric Cancer Masami Nakatani, Hirohisa Machida, Kazunari Tominaga, Hiroaki Minamino, Yasuaki Nagami, Satoshi Sugimori, Natsuhiko Kameda, Hirotoshi Okazaki, Hirokazu Yamagami, Tetsuya Tanigawa, Kenji Watanabe, Toshio Watanabe, Yasuhiro Fujiwara, Tetsuo Arakawa Osaka city university Graduate school of Medicine, Osaka, Japan Background and Aims: Endoscopic submucosal dissection (ESD) is one of curative surgical procedure for early gastric cancer (EGC) in order to obtain a precise pathological examination. Although both lymphovascular involvement and invasion depth of the cancer are critical factors for a prognosis, the effect of these risk factors have not been elucidated. The aim of this study is to evaluate the clinical outcomes and long-term efficacy of ESD for EGC. Patients and Methods: A total of 208 patients with 226 tumors from November 2007 underwent ESD treatment. On the basis of the pathological findings (lymphovascular involvement and invasion depth of cancer) after the resection, the tumors without lymphovascular involvement or massive invasion were assigned to two groups: EGC with average risk for a recurrence (group A: intramucosal tumors less than 20 mm in diameter without ulcerative change) and EGC with moderate risk for a recurrence (group B: intramucosal tumors with ulcerative change less than 30 mm in diameter, tumors less than 30 mm in diameter with slight submucosal invasion, or undifferentiated intramucosal cancer less than 20 mm in diameter). All patients received periodic endoscopic follow-up and enhanced CT for metastatic surveys for at least 3 years. As outcome measures, en bloc resection rate, curative rate (curative defined as en bloc resection and cancer free margin), and 3-year disease-free survival rate. Results: A total of 184 patients (88.4%) were followed-up completely, with a mean observation period of 3.8 (1.4-7.2) years. Subsequently, 199 tumors were assigned to 2 groups; 109 tumors in group A and 90 tumors in group B. En bloc resection rates were 98% and 97%, and curative resection rates were 96% and 89% in group A and B. Curative resection was not achieved in 4 and 10 tumors in group A and B, because of piecemeal resection/ positive or indistinct for lateral margin for the respective tumor (2/2 and 3/7). In cases of lateral margin positive, ESD was performed additionally, patients with indistinct margin were, however, followed-up endoscopically. In long-term results, lymph node or distant metastasis were not detected on CT scan in all patients, but local recurrence was detected one patient in each group at 26 months (group A) and at 6 months (group B) later. For the recurrence, salvage surgery revealed no lymph node metastasis. Subsequently, the disease-free survival rate was 100% in both groups during the follow-up period. Conclusions: ESD might be a curative procedure to promise good prognosis for EGC with average- and moderate-risk after exclusion for the lymphovascular involvement followed by a precise evaluation for the invasion depth of cancer.
AB236 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 4S : 2011
www.giejournal.org