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Sa1616 Mortality From Nonvariceal Upper Gastrointestinal Bleeding: Is It Time to Differentiate the Timing of Endoscopy?
Abstracts
famotidine (20 mg) on the evening before undergoing ESD. All operators were blinded to the assignment until the ESD sessions were completed. The groups received either oral famotidine (20 mg) twice daily after ESD for 8 weeks or intravenous omeprazole (20 mg) twice daily for the first 3 days after ESD followed by oral omeprazole (20 mg) from post-ESD day 4 for 8 weeks. The primary endpoint was the incidence of bleeding that occurred as hematemesis, tarry stools requiring endoscopic hemostatic treatment or a hemoglobin count that was decreased by ⬎2 g/dl. Results: Of the 158 patients, 2 (n ⫽ 1 per group) were excluded from analysis because they withdrew from the study before receiving the study drugs. Accordingly, data from 88 patients per group were analyzed. The rate of delayed bleeding after ESD was 6.4% (5/78) in both groups; 80% (8/10) of delayed bleeding cases developed within 7 days, and the remainder appeared on post-ESD days 10 and 13. No significant side effects were induced by either drug and complete resection rates and patient backgrounds did not significantly differ between the groups. Conclusions: Our results demonstrated that PPIs and H2RAs are equally effective in preventing bleeding from ulcers after ESD, suggesting that hemostatic procedures after ESD are critically important.
Sa1614 A Randomized Controlled Trial of Rebamipide Plus Rabeprazole for Artificial Ulcer Healing After Endoscopic Submucosal Dissection Shoko Fujiwara1, Yoshinori Morita1, Takashi Toyonaga2, Fumi Kawakami3, Tomoo Itoh3, Masaru Yoshida1, Takeshi Azuma1 1 Gastroenterology, Kobe university, School of Medecine, Kobe city, Japan; 2Endoscopy, Kobe university, School of Medecine, Kobe city, Japan; 3Histopathology, Kobe university, School of Medecine, Kobe city, Japan Introduction: Endoscopic submucosal dissection (ESD) is an increasingly common technique for resection of early gastric cancers. Eight weeks proton pump inhibitor (PPI) treatment has been reported to heal patients with ESD induced artificial ulcer; however, anecdotally, not all patients are healed, particularly those with severe atrophic gastritis, for whom there is little data. We aimed to examine whether addition of the non-PPI mucosal healing agent, rebamipide after ESD improves healing rates, particularly in cases of severe atrophic gastritis. Methods: Patients were randomly assigned to two treatment groups following ESD: Rabeprazole 20mg once daily (PPI group) or rebamipide 300mg daily and rabeprazole 20mg daily (combination group). All patients were treated for eight weeks. The primary endpoint was to evaluate the proportion of patients with ulcer healing to scar-stage (S-stage, complete healing) at 56 days after ESD. A pre-specified sub-group analysis examined ulcer healing in patients with severe atrophic gastritis. Results: Overall, progression to S-stage was 54.8% (17/31) in the PPI group, 86.7% (26/30) in the combination group (Odds ratio: 5.3, 95% CI; 1.50 ⬃ 19.02, p⫽0.006), respectively. Patients with atrophic severe gastritis were healed 30.0% (3/10) in the PPI group, and 92.9% (13/14) in the combination group (Odds ratio; 30.3, 2.63 ⬃ 348.91, p⫽0.0023). Conclusion: Treatment with PPI plus rebamipide improved healing rates at eight weeks for patients with ESD-derived artificial ulcer, and appeared particularly effective for patients with severe atrophic gastritis.
Sa1615 Usefulness of Carbon Dioxide Insufflation in Percutaneous Endoscopic Gastrostomy Procedure Shinji Nishiwaki1, Hiroshi Araki2, Masahide Iwashita1, Hayashi Motoshi1, Jun Takada1, Atsushi Tagami1, Hiroo Hatakeyama1, Takao Hayashi1, Teruo Maeda1, Saito Koshiro1 1 Department of Internal Medicine, Nishimino Kosei Hospital, Yorogun, Japan; 2Department of Gastroenterology, Graduate School of Medicine, Gifu University, Gifu, Japan Introduction: Since carbon dioxide (CO2) is rapidly absorbed by the gastrointestinal tract, CO2 insufflation is known to improve the comfort and safety of gastrointestinal endoscopy. However, its use in percutaneous endoscopic gastrostomy (PEG) procedure has not been reported. We investigated the usefulness of CO2 insufflation during the PEG procedure. Methods: A total of 41 patients were enrolled in this study. The patients were scheduled for PEG for the purpose of enteral feeding unless they were disqualified by one of the exclusion criteria: chronic obstructive pulmonary disease, severe congestive heart failure, or refusal to participate. The patients were randomly assigned to either the CO2 group (21 patients) or air insufflation group (20 patients) for the PEG. Carbon dioxide was administered using a CO2 regulator (UCR, Olympus Medical Systems Co.,Tokyo,Japan). PEG was performed using a Ponsky PEG (Bard Access Systems, Inc., Salt Lake City, UT, USA) by pull-through technique after three points fixation of the gastric wall to the abdominal wall using a gastropexy device (Easy Tie, Boston Scientific Japan K.K., Tokyo, Japan). Arterial blood gas analysis was performed immediately
before and after the procedure. Abdominal X-ray was performed at 10 minutes and at 24 hours after PEG to assess the extent of bowel distension. Abdominal CT was performed at 24 hours after the procedure to detect any presence of pneumoperitoneum. Blood analyses were done one day prior and 7 days after PEG. Clinical course and the presence of complications were also compared between the two groups for 7 days after PEG. Results: All the patients successfully underwent the PEG with the exception of one case in the CO2 group with esophageal stenosis. PaCO2 (mmHg) before PEG in the CO2 group and the air group were 38.8 ⫾ 4.9 and 38.6 ⫾ 4.8, respectively, and after PEG were 42.4 ⫾ 5.1 and 41.2 ⫾ 5.5, respectively. There were no adverse events related to CO2 insufflation. Abdominal X-ray revealed that bowel distension was significantly less in the CO2 group compared to the air group. Pneumoperitoneum was observed in 6 patients (30%) in the air group (mean volume of free air: 36.5 ml), but was not observed in the CO2 group. There was no significant difference between the two groups regarding the clinical course after PEG, including complications, blood analyses, and successful initiation of enteral feeding. Conclusion: PEG was performed safely using CO2 insufflation. Although there were no significant differences in the clinical course after PEG between the air and CO2 groups, CO2 insufflation is considered to be safer and more comfortable for patients because of the lower incidence of pneumoperitoneum and less sensation of bowel distension.
Sa1616 Mortality From Nonvariceal Upper Gastrointestinal Bleeding: Is It Time to Differentiate the Timing of Endoscopy? Riccardo Marmo2, Mario Del Piano3, Gianluca Rotondano1, Maurizio Koch4, Maria Antonia Bianco1, Alessandro Zambelli5, Giovanni Di Matteo6, Livio Cipolletta1 1 Gastroenterology, Hospital Maresca, Torre del Greco, Italy; 2Hospital Curto, Polla, Italy; 3AO Maggiore della Carita’, Novara, Italy; 4ACO San Filippo Neri, Roma, Italy; 5AO Ospedale Maggiore, Crema, Italy; 6 IRCCS De Bellis, Castellana Grotte, Italy Background & Aims: patient’s comorbidity is a key risk factor for mortality in non variceal upper GI bleeding (NVUGIB). Almost half of deaths occurs within the first 4 days and about 10% within the first 8 hrs of the index bleeding. Early endoscopy (as soon as possible but always ⬍ 24 hours) is recommended in NVUGIB. Aim of the study was to identify which is the optimal timing of endoscopy that is associated with a reduced risk of death and assess whether this changes according to patients’ clinical conditions. Methods: three national prospective multicentric databases (PNED 1, PNED 2 and PROMETEO) with 30day mortality as primary outcome measure were analysed, including a total of 3207 patients with NVUGIB (2114 males [65.8%], mean age [SD] 68.3 [⫾16.4] years). Recurrent bleeding occurred in 123 patients (3.8%), emergency surgery was deemed necessary in 59 cases (1.8%) and overall mortality rate was 4.45% (143 patients). Patients were classified into low-, medium- or high risk of death according to presence/absence of 10 independent clinical prognosticators identified through logistic regression (age ⬎ 80, in-hospital bleeding, hematemesis, SBP ⬍ 100 mmHg, DBP ⬍ 60 mmHg, HR ⬎ 100 bpm, Hb ⬍ 7 g/ dL, presence of renal failure, cirrhosis or neoplasia). A “propensity score” was used to “correct” the estimation controlling for confounders. Timing of endoscopy was categorized in three time frames: ⱕ 6 hrs, 7-12 hrs and 13-24 hrs. After stratification of cases (deceased) and controls (survived) in homogeneous clinical severity blocks, differences in mortality according to the timing of endoscopy was tested with the chi square test. Results: high-risk patients showed a systematically superior frequency of death compared to those categorised as low- or intermediate risk, independently of the timing of endoscopy (p⬍0.000). For low-risk patients, the frequency of death is not significantly different between the three endoscopy time frames (p ⫽0.192), though it decreases numerically as time frame lengthens (2.07% to 0.63%). In patients at intermediate risk, the frequency of death decreases not significantly in the time frame 13-24 hrs. In patients clinically categorised as high risk, the performance of the endoscopy 13-24 hrs of the bleeding episode is associated with a significantly lower mortality (p⫽0.001) compared to endoscopy performed sooner (ⱕ 12 hrs) (see Table). Conclusions: in patients with NVUGIB who are in good clinical status, timing of endoscopy has no impact on mortality; in patients with worsened health status (high-risk) waiting at least 12 hours prior to perform endoscopy seems to be the option associated with lower mortality, independently of hemodynamic status. Frequency of death (%) Timing of endoscopy Low-risk block Intermediate risk block High-risk block p value ⱕ6 hrs 7-12 hrs 13-24 hrs
2.07 5.74 0.86 6.00 0.63 3.93 p⫽0.192 p⫽0.678 *vs. both low- and intermediate-risk patients
AB224 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 4S : 2011
16.58 14.29 5.15 p⫽0.001*
0.000 0.000 0.000
www.giejournal.org
famotidine (20 mg) on the evening before undergoing ESD. All operators were blinded to the assignment until the ESD sessions were completed. The groups received either oral famotidine (20 mg) twice daily after ESD for 8 weeks or intravenous omeprazole (20 mg) twice daily for the first 3 days after ESD followed by oral omeprazole (20 mg) from post-ESD day 4 for 8 weeks. The primary endpoint was the incidence of bleeding that occurred as hematemesis, tarry stools requiring endoscopic hemostatic treatment or a hemoglobin count that was decreased by ⬎2 g/dl. Results: Of the 158 patients, 2 (n ⫽ 1 per group) were excluded from analysis because they withdrew from the study before receiving the study drugs. Accordingly, data from 88 patients per group were analyzed. The rate of delayed bleeding after ESD was 6.4% (5/78) in both groups; 80% (8/10) of delayed bleeding cases developed within 7 days, and the remainder appeared on post-ESD days 10 and 13. No significant side effects were induced by either drug and complete resection rates and patient backgrounds did not significantly differ between the groups. Conclusions: Our results demonstrated that PPIs and H2RAs are equally effective in preventing bleeding from ulcers after ESD, suggesting that hemostatic procedures after ESD are critically important.
Sa1614 A Randomized Controlled Trial of Rebamipide Plus Rabeprazole for Artificial Ulcer Healing After Endoscopic Submucosal Dissection Shoko Fujiwara1, Yoshinori Morita1, Takashi Toyonaga2, Fumi Kawakami3, Tomoo Itoh3, Masaru Yoshida1, Takeshi Azuma1 1 Gastroenterology, Kobe university, School of Medecine, Kobe city, Japan; 2Endoscopy, Kobe university, School of Medecine, Kobe city, Japan; 3Histopathology, Kobe university, School of Medecine, Kobe city, Japan Introduction: Endoscopic submucosal dissection (ESD) is an increasingly common technique for resection of early gastric cancers. Eight weeks proton pump inhibitor (PPI) treatment has been reported to heal patients with ESD induced artificial ulcer; however, anecdotally, not all patients are healed, particularly those with severe atrophic gastritis, for whom there is little data. We aimed to examine whether addition of the non-PPI mucosal healing agent, rebamipide after ESD improves healing rates, particularly in cases of severe atrophic gastritis. Methods: Patients were randomly assigned to two treatment groups following ESD: Rabeprazole 20mg once daily (PPI group) or rebamipide 300mg daily and rabeprazole 20mg daily (combination group). All patients were treated for eight weeks. The primary endpoint was to evaluate the proportion of patients with ulcer healing to scar-stage (S-stage, complete healing) at 56 days after ESD. A pre-specified sub-group analysis examined ulcer healing in patients with severe atrophic gastritis. Results: Overall, progression to S-stage was 54.8% (17/31) in the PPI group, 86.7% (26/30) in the combination group (Odds ratio: 5.3, 95% CI; 1.50 ⬃ 19.02, p⫽0.006), respectively. Patients with atrophic severe gastritis were healed 30.0% (3/10) in the PPI group, and 92.9% (13/14) in the combination group (Odds ratio; 30.3, 2.63 ⬃ 348.91, p⫽0.0023). Conclusion: Treatment with PPI plus rebamipide improved healing rates at eight weeks for patients with ESD-derived artificial ulcer, and appeared particularly effective for patients with severe atrophic gastritis.
Sa1615 Usefulness of Carbon Dioxide Insufflation in Percutaneous Endoscopic Gastrostomy Procedure Shinji Nishiwaki1, Hiroshi Araki2, Masahide Iwashita1, Hayashi Motoshi1, Jun Takada1, Atsushi Tagami1, Hiroo Hatakeyama1, Takao Hayashi1, Teruo Maeda1, Saito Koshiro1 1 Department of Internal Medicine, Nishimino Kosei Hospital, Yorogun, Japan; 2Department of Gastroenterology, Graduate School of Medicine, Gifu University, Gifu, Japan Introduction: Since carbon dioxide (CO2) is rapidly absorbed by the gastrointestinal tract, CO2 insufflation is known to improve the comfort and safety of gastrointestinal endoscopy. However, its use in percutaneous endoscopic gastrostomy (PEG) procedure has not been reported. We investigated the usefulness of CO2 insufflation during the PEG procedure. Methods: A total of 41 patients were enrolled in this study. The patients were scheduled for PEG for the purpose of enteral feeding unless they were disqualified by one of the exclusion criteria: chronic obstructive pulmonary disease, severe congestive heart failure, or refusal to participate. The patients were randomly assigned to either the CO2 group (21 patients) or air insufflation group (20 patients) for the PEG. Carbon dioxide was administered using a CO2 regulator (UCR, Olympus Medical Systems Co.,Tokyo,Japan). PEG was performed using a Ponsky PEG (Bard Access Systems, Inc., Salt Lake City, UT, USA) by pull-through technique after three points fixation of the gastric wall to the abdominal wall using a gastropexy device (Easy Tie, Boston Scientific Japan K.K., Tokyo, Japan). Arterial blood gas analysis was performed immediately
before and after the procedure. Abdominal X-ray was performed at 10 minutes and at 24 hours after PEG to assess the extent of bowel distension. Abdominal CT was performed at 24 hours after the procedure to detect any presence of pneumoperitoneum. Blood analyses were done one day prior and 7 days after PEG. Clinical course and the presence of complications were also compared between the two groups for 7 days after PEG. Results: All the patients successfully underwent the PEG with the exception of one case in the CO2 group with esophageal stenosis. PaCO2 (mmHg) before PEG in the CO2 group and the air group were 38.8 ⫾ 4.9 and 38.6 ⫾ 4.8, respectively, and after PEG were 42.4 ⫾ 5.1 and 41.2 ⫾ 5.5, respectively. There were no adverse events related to CO2 insufflation. Abdominal X-ray revealed that bowel distension was significantly less in the CO2 group compared to the air group. Pneumoperitoneum was observed in 6 patients (30%) in the air group (mean volume of free air: 36.5 ml), but was not observed in the CO2 group. There was no significant difference between the two groups regarding the clinical course after PEG, including complications, blood analyses, and successful initiation of enteral feeding. Conclusion: PEG was performed safely using CO2 insufflation. Although there were no significant differences in the clinical course after PEG between the air and CO2 groups, CO2 insufflation is considered to be safer and more comfortable for patients because of the lower incidence of pneumoperitoneum and less sensation of bowel distension.
Sa1616 Mortality From Nonvariceal Upper Gastrointestinal Bleeding: Is It Time to Differentiate the Timing of Endoscopy? Riccardo Marmo2, Mario Del Piano3, Gianluca Rotondano1, Maurizio Koch4, Maria Antonia Bianco1, Alessandro Zambelli5, Giovanni Di Matteo6, Livio Cipolletta1 1 Gastroenterology, Hospital Maresca, Torre del Greco, Italy; 2Hospital Curto, Polla, Italy; 3AO Maggiore della Carita’, Novara, Italy; 4ACO San Filippo Neri, Roma, Italy; 5AO Ospedale Maggiore, Crema, Italy; 6 IRCCS De Bellis, Castellana Grotte, Italy Background & Aims: patient’s comorbidity is a key risk factor for mortality in non variceal upper GI bleeding (NVUGIB). Almost half of deaths occurs within the first 4 days and about 10% within the first 8 hrs of the index bleeding. Early endoscopy (as soon as possible but always ⬍ 24 hours) is recommended in NVUGIB. Aim of the study was to identify which is the optimal timing of endoscopy that is associated with a reduced risk of death and assess whether this changes according to patients’ clinical conditions. Methods: three national prospective multicentric databases (PNED 1, PNED 2 and PROMETEO) with 30day mortality as primary outcome measure were analysed, including a total of 3207 patients with NVUGIB (2114 males [65.8%], mean age [SD] 68.3 [⫾16.4] years). Recurrent bleeding occurred in 123 patients (3.8%), emergency surgery was deemed necessary in 59 cases (1.8%) and overall mortality rate was 4.45% (143 patients). Patients were classified into low-, medium- or high risk of death according to presence/absence of 10 independent clinical prognosticators identified through logistic regression (age ⬎ 80, in-hospital bleeding, hematemesis, SBP ⬍ 100 mmHg, DBP ⬍ 60 mmHg, HR ⬎ 100 bpm, Hb ⬍ 7 g/ dL, presence of renal failure, cirrhosis or neoplasia). A “propensity score” was used to “correct” the estimation controlling for confounders. Timing of endoscopy was categorized in three time frames: ⱕ 6 hrs, 7-12 hrs and 13-24 hrs. After stratification of cases (deceased) and controls (survived) in homogeneous clinical severity blocks, differences in mortality according to the timing of endoscopy was tested with the chi square test. Results: high-risk patients showed a systematically superior frequency of death compared to those categorised as low- or intermediate risk, independently of the timing of endoscopy (p⬍0.000). For low-risk patients, the frequency of death is not significantly different between the three endoscopy time frames (p ⫽0.192), though it decreases numerically as time frame lengthens (2.07% to 0.63%). In patients at intermediate risk, the frequency of death decreases not significantly in the time frame 13-24 hrs. In patients clinically categorised as high risk, the performance of the endoscopy 13-24 hrs of the bleeding episode is associated with a significantly lower mortality (p⫽0.001) compared to endoscopy performed sooner (ⱕ 12 hrs) (see Table). Conclusions: in patients with NVUGIB who are in good clinical status, timing of endoscopy has no impact on mortality; in patients with worsened health status (high-risk) waiting at least 12 hours prior to perform endoscopy seems to be the option associated with lower mortality, independently of hemodynamic status. Frequency of death (%) Timing of endoscopy Low-risk block Intermediate risk block High-risk block p value ⱕ6 hrs 7-12 hrs 13-24 hrs
2.07 5.74 0.86 6.00 0.63 3.93 p⫽0.192 p⫽0.678 *vs. both low- and intermediate-risk patients
AB224 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 4S : 2011
16.58 14.29 5.15 p⫽0.001*
0.000 0.000 0.000
www.giejournal.org