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The Safety and Efficacy of the Endoscopic Submucosal Dissection for Early Gastric Cancers, Compared with Conventional Endoscopic Mucosal Resection
Abstracts
W1407 Extreme Variations in Pre-Endoscopic Care of High-Risk Nonvariceal Upper GI Hemorrhage (NVUGIH): Results of a National Vignette Survey of Experts Versus Community Providers Brennan M. Spiegel, Ian M. Gralnek, Loren Laine, Dennis M. Jensen, Gareth S. Dulai, Glenn M. Eisen Background: Although EGD is the mainstay of high-risk NVUGIH management, preEGD care is critical to optimize outcomes. Yet there is uncertainty about what defines ‘‘best practice’’ in pre-EGD management. Three areas, in particular, have been debated: (1) need for nasogastric lavage (NGL), (2) use of gastric motility agents, and (3) optimal pre-EGD disposition. We conducted a national survey to measure current practice in these 3 areas in a group of experts (Ex) and ‘‘nonexpert’’ community providers (NEx). Methods: We developed an online survey that included a vignette of a high-risk NVUGIH patient. Respondents viewed a standardized presentation of a high-risk patient (summary: 42 yo on ASA with melena, epigastric pain, orthostatic BP, no stigmata of liver disease, Hgb Z 11), and then received management questions guided by branching conditional logic. Upon EGD, respondents viewed an image of a ‘‘spurting’’ vessel in an ulcer. We measured appropriateness of pre-EGD NGL and motility agents using a standard 9-point RAND Appropriateness Scale (RAS) (1-3 Z inappropriate, 4-6 Z unsure, 7-9 Z appropriate), and calculated the RAND Disagreement Index (DI) for each set of ratings. The DI is a validated measure of provider variation (DIR1.0 Z ‘‘extreme variation,’’ !1.0 Z acceptable variation). We surveyed a random sample of 360 GIs from the AGA, and 40 internationally recognized NVUGIH experts. Results: 47% responded (N Z 188; 25 experts). Both Ex and NEx groups were generally ‘‘unsure’’ about the appropriateness of NGL (Ex RAS Z 5.8; NEx RAS Z 5.7; p Z 0.8). However, both groups were internally conflicted and polarized, and thus exhibited ‘‘extreme variation’’ regarding NGL (Ex & NEx DI Z 4.7). Both groups rated metoclopramide as generally inappropriate (Ex RAS Z 3.5, DI Z 0.7; NEx RAS Z 3.3, DI Z 0.8), but rated erythromycin as more appropriate (Ex RAS Z 5.4; NEx RAS Z 4.1; p Z 0.02). However, both groups exhibited extreme variation regarding use of erythromycin (Ex DI Z 2.3; NEx DI Z 1.6). The most common dispo was transfer to GI suite for immediate EGD (31%), followed by ICU (29%), remain in ER for EGD (15%), monitored floor bed (14%), and non-monitored bed (6%). There was no difference in dispo between Ex and NEx. Conclusions: Both experts and non-experts exhibit extreme variation in their opinion about NGL and promotility agents in the pre-EGD evaluation of high-risk NVUGIH. Although most providers maintain high-risk patients in a monitored environment, there is large variation in the site of monitoring. These variations within and between groups indicate that ‘‘best practices’’ in pre-EGD care remain uncertain and should be subjected to further research and guideline development.
66,3 15,2 (p Z 0.001), presence of severe comorbidity, use of nitrates (OR 4.0 [95% CI 1.9-8.8]), presence of blood in gastric cavity hampering endoscopic diagnosis (OR 14.7 [95% 4.6-46.9]), failure of endoscopic haemostasis (OR 72.9 (95% CI 14.2 - 372.5), recurrent bleeding (OR 4,12 [95% CI 1.5-11.2]), no PPI use after endoscopic therapy (OR 4.28 [95% CI 1.36-11.34]) and transfusion requirements (OR 2,67 [95% CI 1.46-4.85]). Conclusions: overall mortality from non variceal UGIB in Italy is low (4.5%). Deaths occurred almost exclusively in elderly patients with severe co-morbidities, independently of the type of endoscopic treatment delivered. Between the endoscopic findings, the presence of blood in the gastric cavity hampering the diagnosis and endoscopic therapy failure are, over all, the most relevant prognostic factor for death. Prompt resort to surgery should be considered for surgically fit patients in whom endoscopy therapy fails to treat the stigmata in the first 24 hours.
W1409 The Safety and Efficacy of the Endoscopic Submucosal Dissection for Early Gastric Cancers, Compared with Conventional Endoscopic Mucosal Resection Shu Hoteya, Toshiro Iizuka, Mitsuyo Hashimoto, Hideo Mizuno, Takahumi Otsuka, Tomoko Noguchi, Daisuke Kikuchi, Yutaka Hirayama, Kouichirou Kawano, Naohisa Yahagi W1408 Factor Associated with Mortality from Non Variceal Upper Gastrointestinal Bleeding (UGIB) in Italy: A Nationwide Prospective Study Riccardo Marmo, M. Koch, L. Cipolletta, L. Capurso, G. Rotondano, Maria Antonietta Bianco, A. Dezi, A. Pastorelli, E. Sanz Torre, I. Lorenzini, L. Girardi, P. Romagnoli, D. Della Casa, A. Buzzi, R. Fasoli, S. Brunati, U. Germani, G. Di Matteo, P. Giorgio, G. Imperiali, G. Minoli, F. Barberani, S. Boschetto, G. Gatto, M. Amuso Background: The death is the most relevant outcome for any study. The death from non-variceal UGIB may occur in particular if advanced age and life-threatening co-morbidities are present. Other factors i.e endoscopic and pharmacological treatment, timing of endoscopy are not yet recognized as having prognostic impact. Aim: assess the mortality rate from nonvariceal UGIB and identify clinical, endoscopic and therapeutic prognostic factors of mortality. Methods: A multicentre, prospective database study was carried out in 23 hospitals receiving emergency admissions. Outcome measure was 30-day mortality. Results: Over a 12 months period a total of 1020 patients with non variceal UGIB were entered in a national database and analysed. Peptic ulcer bleeding accounted for 66% of the cases. Ulcerogenic co-prescriptions were recorded in 51.4% of patients. One or more comorbidities were recorded at the time of presentation in 53% of cases. Overall mortality was 4.5% [95% CI 3.3-6.0] (46/1020). In all, 39/46 (85%) deaths were associated with one or more major comorbidities. Sixteen patients (34,8% [95% CI 22.1-49.3) died within the first 24 hours of the onset of bleeding, with 10 patients deceased within 8 hours of the endoscopic examination. Nine patients had been categorised as ASA class III or IV whereas 7 patients as ASA class I or II and none of them was operated upon. In four of them there had been a failure of endoscopic haemostasis. For the remaining 30 patients, death occurred within 7 days in 50% and within 12 days in 75% of cases. Factors associated with increased risk of mortality were advanced age 76,6 14,0 (p Z 0.000), low diastolic pressure
AB358 GASTROINTESTINAL ENDOSCOPY Volume 65, No. 5 : 2007
Background: ESD was developed to enable us to resect much larger and difficult lesions, which are unable to resect with conventional EMR techniques. But, it involves much higher complication rate and requires much higher skills. Objective: We evaluated the safety and efficacy according to the clinical outcome of ESD performed for early gastric cancer (EGC) in our institution compared with conventional EMR. Patients: From January 2000 to September 2005, 350 lesions with EGC were treated by conventional EMR. From April 2005 to October 2006, 304 lesions with EGC were treated by ESD. We diagnosed the lesions and classified them with the following criteria according to the Guidelines of Japanese Gastric Cancer Association before treatment; 1. Standard criteria: mainly small mucosal cancers of differentiated type, less than 2 cm and 2. Extended criteria: much larger and difficult lesions but with a little risk for lymph node metastasis. According to these conditions, lesions met standard criteria and extended criteria for endoscopic resection were 305 and 45 in EMR group, and 151 and 153 in ESD group, respectively. Methods: The en bloc resection rate, curative resection rate, complication (perforation and postoperative bleeding) rate and local recurrence rate were evaluated in both groups. Results: The overall en bloc resection rate were 62.6% and 96.7% in the EMR group and the ESD group. En bloc resection rate were increased up to 66.9% and 98.7% in each group, in case of small lesions meet standard criteria. And they were decreased to 33.3% and 94.8% in each group, in case of larger and difficult lesions meet extended criteria. The overall curative resection rate were 58.3% and 83.6% in the EMR group and the ESD group. Curative resection rate were increased to 62.3% and 93.4% in each group, in case of small lesions meet standard criteria. And they were decreased to 31.1% and 73.9% in each group, in case of larger and difficult lesions meet extended criteria. Perforation rate were 1.4% and 3.6%, and postoperative bleeding rate were 5.1% and 3.2% in the EMR group and the ESD group, respectively. Local recurrence were detected in 13 patients (2.6%) of the EMR group. And no local recurrence was detected in the ESD group within the followed up period. Conclusuions: Safety and efficacy of ESD were far better than conventional EMR. Therefore, it is desirable that ESD becomes a standard treatment option for early gastric cancer, although it requires much higher skills of the endoscopists.
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W1407 Extreme Variations in Pre-Endoscopic Care of High-Risk Nonvariceal Upper GI Hemorrhage (NVUGIH): Results of a National Vignette Survey of Experts Versus Community Providers Brennan M. Spiegel, Ian M. Gralnek, Loren Laine, Dennis M. Jensen, Gareth S. Dulai, Glenn M. Eisen Background: Although EGD is the mainstay of high-risk NVUGIH management, preEGD care is critical to optimize outcomes. Yet there is uncertainty about what defines ‘‘best practice’’ in pre-EGD management. Three areas, in particular, have been debated: (1) need for nasogastric lavage (NGL), (2) use of gastric motility agents, and (3) optimal pre-EGD disposition. We conducted a national survey to measure current practice in these 3 areas in a group of experts (Ex) and ‘‘nonexpert’’ community providers (NEx). Methods: We developed an online survey that included a vignette of a high-risk NVUGIH patient. Respondents viewed a standardized presentation of a high-risk patient (summary: 42 yo on ASA with melena, epigastric pain, orthostatic BP, no stigmata of liver disease, Hgb Z 11), and then received management questions guided by branching conditional logic. Upon EGD, respondents viewed an image of a ‘‘spurting’’ vessel in an ulcer. We measured appropriateness of pre-EGD NGL and motility agents using a standard 9-point RAND Appropriateness Scale (RAS) (1-3 Z inappropriate, 4-6 Z unsure, 7-9 Z appropriate), and calculated the RAND Disagreement Index (DI) for each set of ratings. The DI is a validated measure of provider variation (DIR1.0 Z ‘‘extreme variation,’’ !1.0 Z acceptable variation). We surveyed a random sample of 360 GIs from the AGA, and 40 internationally recognized NVUGIH experts. Results: 47% responded (N Z 188; 25 experts). Both Ex and NEx groups were generally ‘‘unsure’’ about the appropriateness of NGL (Ex RAS Z 5.8; NEx RAS Z 5.7; p Z 0.8). However, both groups were internally conflicted and polarized, and thus exhibited ‘‘extreme variation’’ regarding NGL (Ex & NEx DI Z 4.7). Both groups rated metoclopramide as generally inappropriate (Ex RAS Z 3.5, DI Z 0.7; NEx RAS Z 3.3, DI Z 0.8), but rated erythromycin as more appropriate (Ex RAS Z 5.4; NEx RAS Z 4.1; p Z 0.02). However, both groups exhibited extreme variation regarding use of erythromycin (Ex DI Z 2.3; NEx DI Z 1.6). The most common dispo was transfer to GI suite for immediate EGD (31%), followed by ICU (29%), remain in ER for EGD (15%), monitored floor bed (14%), and non-monitored bed (6%). There was no difference in dispo between Ex and NEx. Conclusions: Both experts and non-experts exhibit extreme variation in their opinion about NGL and promotility agents in the pre-EGD evaluation of high-risk NVUGIH. Although most providers maintain high-risk patients in a monitored environment, there is large variation in the site of monitoring. These variations within and between groups indicate that ‘‘best practices’’ in pre-EGD care remain uncertain and should be subjected to further research and guideline development.
66,3 15,2 (p Z 0.001), presence of severe comorbidity, use of nitrates (OR 4.0 [95% CI 1.9-8.8]), presence of blood in gastric cavity hampering endoscopic diagnosis (OR 14.7 [95% 4.6-46.9]), failure of endoscopic haemostasis (OR 72.9 (95% CI 14.2 - 372.5), recurrent bleeding (OR 4,12 [95% CI 1.5-11.2]), no PPI use after endoscopic therapy (OR 4.28 [95% CI 1.36-11.34]) and transfusion requirements (OR 2,67 [95% CI 1.46-4.85]). Conclusions: overall mortality from non variceal UGIB in Italy is low (4.5%). Deaths occurred almost exclusively in elderly patients with severe co-morbidities, independently of the type of endoscopic treatment delivered. Between the endoscopic findings, the presence of blood in the gastric cavity hampering the diagnosis and endoscopic therapy failure are, over all, the most relevant prognostic factor for death. Prompt resort to surgery should be considered for surgically fit patients in whom endoscopy therapy fails to treat the stigmata in the first 24 hours.
W1409 The Safety and Efficacy of the Endoscopic Submucosal Dissection for Early Gastric Cancers, Compared with Conventional Endoscopic Mucosal Resection Shu Hoteya, Toshiro Iizuka, Mitsuyo Hashimoto, Hideo Mizuno, Takahumi Otsuka, Tomoko Noguchi, Daisuke Kikuchi, Yutaka Hirayama, Kouichirou Kawano, Naohisa Yahagi W1408 Factor Associated with Mortality from Non Variceal Upper Gastrointestinal Bleeding (UGIB) in Italy: A Nationwide Prospective Study Riccardo Marmo, M. Koch, L. Cipolletta, L. Capurso, G. Rotondano, Maria Antonietta Bianco, A. Dezi, A. Pastorelli, E. Sanz Torre, I. Lorenzini, L. Girardi, P. Romagnoli, D. Della Casa, A. Buzzi, R. Fasoli, S. Brunati, U. Germani, G. Di Matteo, P. Giorgio, G. Imperiali, G. Minoli, F. Barberani, S. Boschetto, G. Gatto, M. Amuso Background: The death is the most relevant outcome for any study. The death from non-variceal UGIB may occur in particular if advanced age and life-threatening co-morbidities are present. Other factors i.e endoscopic and pharmacological treatment, timing of endoscopy are not yet recognized as having prognostic impact. Aim: assess the mortality rate from nonvariceal UGIB and identify clinical, endoscopic and therapeutic prognostic factors of mortality. Methods: A multicentre, prospective database study was carried out in 23 hospitals receiving emergency admissions. Outcome measure was 30-day mortality. Results: Over a 12 months period a total of 1020 patients with non variceal UGIB were entered in a national database and analysed. Peptic ulcer bleeding accounted for 66% of the cases. Ulcerogenic co-prescriptions were recorded in 51.4% of patients. One or more comorbidities were recorded at the time of presentation in 53% of cases. Overall mortality was 4.5% [95% CI 3.3-6.0] (46/1020). In all, 39/46 (85%) deaths were associated with one or more major comorbidities. Sixteen patients (34,8% [95% CI 22.1-49.3) died within the first 24 hours of the onset of bleeding, with 10 patients deceased within 8 hours of the endoscopic examination. Nine patients had been categorised as ASA class III or IV whereas 7 patients as ASA class I or II and none of them was operated upon. In four of them there had been a failure of endoscopic haemostasis. For the remaining 30 patients, death occurred within 7 days in 50% and within 12 days in 75% of cases. Factors associated with increased risk of mortality were advanced age 76,6 14,0 (p Z 0.000), low diastolic pressure
AB358 GASTROINTESTINAL ENDOSCOPY Volume 65, No. 5 : 2007
Background: ESD was developed to enable us to resect much larger and difficult lesions, which are unable to resect with conventional EMR techniques. But, it involves much higher complication rate and requires much higher skills. Objective: We evaluated the safety and efficacy according to the clinical outcome of ESD performed for early gastric cancer (EGC) in our institution compared with conventional EMR. Patients: From January 2000 to September 2005, 350 lesions with EGC were treated by conventional EMR. From April 2005 to October 2006, 304 lesions with EGC were treated by ESD. We diagnosed the lesions and classified them with the following criteria according to the Guidelines of Japanese Gastric Cancer Association before treatment; 1. Standard criteria: mainly small mucosal cancers of differentiated type, less than 2 cm and 2. Extended criteria: much larger and difficult lesions but with a little risk for lymph node metastasis. According to these conditions, lesions met standard criteria and extended criteria for endoscopic resection were 305 and 45 in EMR group, and 151 and 153 in ESD group, respectively. Methods: The en bloc resection rate, curative resection rate, complication (perforation and postoperative bleeding) rate and local recurrence rate were evaluated in both groups. Results: The overall en bloc resection rate were 62.6% and 96.7% in the EMR group and the ESD group. En bloc resection rate were increased up to 66.9% and 98.7% in each group, in case of small lesions meet standard criteria. And they were decreased to 33.3% and 94.8% in each group, in case of larger and difficult lesions meet extended criteria. The overall curative resection rate were 58.3% and 83.6% in the EMR group and the ESD group. Curative resection rate were increased to 62.3% and 93.4% in each group, in case of small lesions meet standard criteria. And they were decreased to 31.1% and 73.9% in each group, in case of larger and difficult lesions meet extended criteria. Perforation rate were 1.4% and 3.6%, and postoperative bleeding rate were 5.1% and 3.2% in the EMR group and the ESD group, respectively. Local recurrence were detected in 13 patients (2.6%) of the EMR group. And no local recurrence was detected in the ESD group within the followed up period. Conclusuions: Safety and efficacy of ESD were far better than conventional EMR. Therefore, it is desirable that ESD becomes a standard treatment option for early gastric cancer, although it requires much higher skills of the endoscopists.
www.giejournal.org