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Prevention of Delayed Bleeding After Endoscopic Submucosal Dissection (ESD) for Gastric Tumors
the tumor diameter, the depth of tumor invasion,, interval of delayed breeding. Result: We observed delayed bleeding in 15 cases (3.9%). As for the tumor location, it had a significant difference that delayed bleeding rate was higher in lower third of stomach (6.1%) than in the other parts of stomach (P<0.05). As for the tumor diameter, delayed bleeding rate in 20mm or more was significantly higher than in 19mm or less. The significant difference was not observed in the age, the sex, the depth of tumor invasion. There were most of delayed bleeding within 24 hours after ESD (86.6%). Therefore we chose a high risk group based on this result. Forty three of 272 cases were a high risk groups in which the lesion was located lower part of the stomach and 2cm or more between January 1, 2008 and August 31, 2010. We examined follow up endoscopy three hours after ESD in order to confirm presence of the hemorrhage from artificial ulcer. When it seemed that we had better perform prophylactic hemostasis, the electrocoagulation with hemostatic forceps was performed. It was in 15 cases (34.9%) in high risk group that prophylactic hemostasis was performed. We observed the delayed bleeding in 3 cases(1.1%). Conclusion: The risk factor of delayed bleeding after ESD were significantly in lower third of stomach and in 2cm or more for tumor diameter. The majority of the delayed bleeding was caused within 24 hours after ESD. It is useful to examine follow up endoscopy three hours after ESD in order to confirm presence of the hemorrhage from artificial ulcer in a high risk group.
Inhibitory Effect of Lansoprazole on Bleeding From Artificial Ulcers After Endoscopic Submucosal Dissection for Gastric Tumors: A Prospective Randomized Study Satoshi Tanabe, Katsuhiko Higuchi, Kenji Ishido, Tohru Sasaki, Mizutomo Azuma, Chikatoshi Katada, Takako Ae, Akira Naruke, Wasaburo Koizumi Background: Artificial ulcers developing after endoscopic submucosal dissection (ESD) are widely treated first by intravenous proton pump inhibitors (PPIs), followed by oral PPIs. Few studies have evaluated the inhibitory effect of initial treatment with oral PPIs on artificial ulcer bleeding. Objectives: To clarify whether lansoprazole orally disintegrating (OD) tablets are non-inferior to intravenous lansoprazole with respect to the inhibitory effect on artificial ulcer bleeding. Patients and Methods: In this prospective, randomized, controlled study, 310 patients who underwent ESD for gastric neoplasms were randomly assigned to receive lansoprazole OD tablets (30 mg daily), given for 8 weeks starting the day before ESD (OD group), or intravenous lansoprazole (30 mg twice daily), given by infusion on the day before ESD, the day of ESD, and the day after ESD, followed by 8 weeks' treatment with lansoprazole OD tablets (30 mg daily; IV group). On the day after ESD, second-look endoscopy was performed. The primary endpoint was the incidence of bleeding that required endoscopic hemostasis at second-look endoscopy. Endoscopic hemostasis was indicated for the treatment of Forrest Ia or Ib active bleeding. For statistical analysis, the Dunnett-Gent non-inferiority test was used, with a non-inferiority margin of 10%. One-sided P values of less than 0.05 were considered to indicate statistical significance. Results: Data from 310 patients were included in the intention-to-treat analysis. The per-protocol analysis included data from 304 patients (152 of 156 in the OD group and 152 of 154 in the IV group). Endoscopic hemostasis was performed at second-look endoscopy in 17 patients (11.2%) in the OD group and 19 (12.5%) in the IV group (difference, 1.3%; 90% confidence interval, -4.8% to 7.4%; p<0.001). The results of the intention-to-treat analysis were similar to those of the per-protocol analysis. Overall, overt bleeding (hematemesis and melena) occurred in only 4 (1.3%) of 304 patients (2 in the OD group and 2 in the IV group). Conclusions: The inhibitory effect of lansoprazole OD tablets on artificial ulcer bleeding after ESD was similar to that of intravenous lansoprazole. Oral as well as intravenous lansoprazole effectively prevented bleeding from artificial ulcers after ESD. Lansoprazole OD tablets are cost-effective and may become a treatment of first choice for the prophylaxis of artificial ulcers after ESD.
Sa1143 A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab John C. Fang, Kristen Hilden, Gerald J. Gleich, Lyska L. Emerson, Molly A. Ogorman, Amy Lowichik, Kathryn Peterson Intro: Eosinophilic Esophagitis (EoE) is characterized by obstructive esophageal symptoms and dense esophageal eosinophilia in children and young adults. EoE appears to be a TH2, IL-5, mast cell, IgE associated disease process similar to the immune mechanisms involved in asthma. Omalizumab is a recently developed anti-IgE antibody that selectively binds to human IgE and has been shown to be effective in treatment of extrinsic asthma. We hypothesized that Omalizumab would be effective in the treatment of EoE. Aim: To determine the efficacy of omalizumab in reducing the eosinophilic esophageal infiltration in EoE patients. The secondary objective is to determine the efficacy of omalizumab in reducing the symptoms of EoE. Methods: Prospective randomized, double-blind, placebo-controlled trial of subjects (age 12-60) who were either refractory to or relapsed after a trial of therapy with topical corticosteroids. EoE was defined as the presence of esophageal symptoms (dysphagia, chest pain, food impaction, heartburn) and ≥20 eos/ hpf averaged from 4 quadrant biopsies taken from proximal and distal esophagus. Subjects were placed on PPI therapy for duration of study to exclude GERD. Subjects were randomized to receive omalizumab or placebo at Day 1 and every 4 weeks for 16 weeks. Dysphagia scores were obtained at baseline and every 4 weeks. Wilcoxon signed rank and rank sum tests were used to compare dysphagia scores and eosinophil concentrations within and between groups. Results: 30 subjects were enrolled and completed treatment. The mean age for both groups was 30 years (range 15-52). Twenty-four subjects were male (80%). The eosinophil concentration proximally and distally did not change significantly in either group post-treatment. The dysphagia score did improve significantly in both groups when comparing the baseline score to the week 16 (omalizumab group p<0.0001, placebo group p=0.02). However, the improvement in dysphagia score was not significant between groups (see table). The serum IgE level increased significantly in the omalizumab group between pre and post-treatment (p<0.0001) confirming drug effect. Conclusion: There was no improvement in the eosinophil infiltration with placebo or omalizumab treatment in EoE patients. Dysphagia scores improved similarly with both omalizumab and placebo. Omalizumab does not appear to be effective in the treatment of EoE. Results Table
Sa1141 Is Malignant Seeding of the Percutaneous Endoscopic Gastrostomy (PEG) Tract a Rare Complication?- A Prospective and Systematic Pilot Study Petr Sergueev, Mark Ellrichmann, Victor Kataev, Alexander Arlt, Perdita Wietzke-Braun, Theodoros Topalidis, Annette Fritscher-Ravens Introduction: Insertion of a percutaneous endoscopic gastrostomy (PEG) is a standard procedure in many patients with esophageal malignancies or cancers of the throat (ENT) to allow enteral feeding in connection with oncological treatment. During the endoscopic placement procedure, the tumors get into direct contact with the placement tube (PT) or the security plate. Development of metastases at PEG outlet sites at the abdominal wall, representing a late complication, has been reported in single cases throughout the world but is thought to represent a rare complication. But many of the patients might not live long enough to get to this late stage, so that the true seeding rate in unknown. As with modern treatment options the survival rates are improving, this information might be of importance. Aim: To prospectively and systematically evaluate the rate of malignant cell seeding at the abdominal wall pull-through site at the time of the PEG placement. Methods: This pilot study includes the first 15 consecutive cases of an overall of 50 intended patients with tumors, that allow direct contact with the placement tube during insertion. Standard pull-technique was used for PEG placement using a norm gastroscope. Immediately after the PEG procedure, brush cytology was taken from the PEG tubing as well as from the transcutaneous incision site. Results: 15 consecutive patients,13 with ENT tumors and 2 with esophageal cancers received a PEG without any complication. Subsequent cytology of the brushing of the tube and incision site proved malignant cells present on cytology in 4 of the 15 cases (27%) and none in the remaining 11. Both of the two esophageal cancers had produced seeding, while only 2/13 with ENT tumors showed malignancy at the abdominal wall on cytology. Conclusion: In this small series, the rate of malignant seeding was 27%. As oncological tumor treatment becomes more successful and patients may survive these cancers longer in the future it might be worth while considering to abandon the pull-through PEG tube technique and substitute it with a direct placement technique. It is noteworthy that both the two esophageal cancers produced seeding, which might hint at a higher rate of seeding of these tumors when compared with ENT cancers. However, these small numbers cannot provide sufficient data for this statement and the final study results might provide better insights into the spread of malignancies in relation to tumor etiologies. Sa1142 Prevention of Delayed Bleeding After Endoscopic Submucosal Dissection (ESD) for Gastric Tumors Yutaka Asakuma, Shigenaga Matsui, Masanori Kawasaki, Toshiharu Sakurai, Hiroshi Kashida, Masatoshi Kudo
Sa1144
Objective: Recently, the treatment of the early gastric cancer by endoscopic submucosal dissection (ESD) is becoming more and more popular and established. However, we sometimes experience several complications. Delayed bleeding is one of the major complications of ESD for gastric tumors. It is necessary to analyze the tendency and better measures for preventing delayed bleeding. We examined retrospectively the patient characteristics to search for the factor of the delayed bleeding after ESD for gastric tumor. Method: Three hundred thirty patients with gastric tumors (386 lesions) underwent ESD between August 1, 2002 and December 31, 2007. Delayed bleeding was defined as hematemesis or melena that required endoscopic hemostatic procedure or decreased the hemoglobin count by more than 2g/dl after ESD. We analyzed several factors such as the age, the sex, the tumor location,
The Role of GERD in Eosinophilic Esophagitis Dawn L. Francis, Amindra S. Arora, Kim L. Jensen, Sara Linker-Nord, Amy E. FoxxOrenstein Background: There is overlap between Eosinophilic Esophagitis (EoE) and GERD. Recent data suggest that the differentiation between GERD and EoE can not be made on density of eosinophilic infiltrate alone or by presence of GERD symptoms. As a result, the extent to which the diseases overlap has been difficult to ascertain and has not been objectively evaluated in a large prospective trial. We aimed to define the prevalence of GERD in patients
S-235
AGA Abstracts
AGA Abstracts
Sa1140
Inhibitory Effect of Lansoprazole on Bleeding From Artificial Ulcers After Endoscopic Submucosal Dissection for Gastric Tumors: A Prospective Randomized Study Satoshi Tanabe, Katsuhiko Higuchi, Kenji Ishido, Tohru Sasaki, Mizutomo Azuma, Chikatoshi Katada, Takako Ae, Akira Naruke, Wasaburo Koizumi Background: Artificial ulcers developing after endoscopic submucosal dissection (ESD) are widely treated first by intravenous proton pump inhibitors (PPIs), followed by oral PPIs. Few studies have evaluated the inhibitory effect of initial treatment with oral PPIs on artificial ulcer bleeding. Objectives: To clarify whether lansoprazole orally disintegrating (OD) tablets are non-inferior to intravenous lansoprazole with respect to the inhibitory effect on artificial ulcer bleeding. Patients and Methods: In this prospective, randomized, controlled study, 310 patients who underwent ESD for gastric neoplasms were randomly assigned to receive lansoprazole OD tablets (30 mg daily), given for 8 weeks starting the day before ESD (OD group), or intravenous lansoprazole (30 mg twice daily), given by infusion on the day before ESD, the day of ESD, and the day after ESD, followed by 8 weeks' treatment with lansoprazole OD tablets (30 mg daily; IV group). On the day after ESD, second-look endoscopy was performed. The primary endpoint was the incidence of bleeding that required endoscopic hemostasis at second-look endoscopy. Endoscopic hemostasis was indicated for the treatment of Forrest Ia or Ib active bleeding. For statistical analysis, the Dunnett-Gent non-inferiority test was used, with a non-inferiority margin of 10%. One-sided P values of less than 0.05 were considered to indicate statistical significance. Results: Data from 310 patients were included in the intention-to-treat analysis. The per-protocol analysis included data from 304 patients (152 of 156 in the OD group and 152 of 154 in the IV group). Endoscopic hemostasis was performed at second-look endoscopy in 17 patients (11.2%) in the OD group and 19 (12.5%) in the IV group (difference, 1.3%; 90% confidence interval, -4.8% to 7.4%; p<0.001). The results of the intention-to-treat analysis were similar to those of the per-protocol analysis. Overall, overt bleeding (hematemesis and melena) occurred in only 4 (1.3%) of 304 patients (2 in the OD group and 2 in the IV group). Conclusions: The inhibitory effect of lansoprazole OD tablets on artificial ulcer bleeding after ESD was similar to that of intravenous lansoprazole. Oral as well as intravenous lansoprazole effectively prevented bleeding from artificial ulcers after ESD. Lansoprazole OD tablets are cost-effective and may become a treatment of first choice for the prophylaxis of artificial ulcers after ESD.
Sa1143 A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab John C. Fang, Kristen Hilden, Gerald J. Gleich, Lyska L. Emerson, Molly A. Ogorman, Amy Lowichik, Kathryn Peterson Intro: Eosinophilic Esophagitis (EoE) is characterized by obstructive esophageal symptoms and dense esophageal eosinophilia in children and young adults. EoE appears to be a TH2, IL-5, mast cell, IgE associated disease process similar to the immune mechanisms involved in asthma. Omalizumab is a recently developed anti-IgE antibody that selectively binds to human IgE and has been shown to be effective in treatment of extrinsic asthma. We hypothesized that Omalizumab would be effective in the treatment of EoE. Aim: To determine the efficacy of omalizumab in reducing the eosinophilic esophageal infiltration in EoE patients. The secondary objective is to determine the efficacy of omalizumab in reducing the symptoms of EoE. Methods: Prospective randomized, double-blind, placebo-controlled trial of subjects (age 12-60) who were either refractory to or relapsed after a trial of therapy with topical corticosteroids. EoE was defined as the presence of esophageal symptoms (dysphagia, chest pain, food impaction, heartburn) and ≥20 eos/ hpf averaged from 4 quadrant biopsies taken from proximal and distal esophagus. Subjects were placed on PPI therapy for duration of study to exclude GERD. Subjects were randomized to receive omalizumab or placebo at Day 1 and every 4 weeks for 16 weeks. Dysphagia scores were obtained at baseline and every 4 weeks. Wilcoxon signed rank and rank sum tests were used to compare dysphagia scores and eosinophil concentrations within and between groups. Results: 30 subjects were enrolled and completed treatment. The mean age for both groups was 30 years (range 15-52). Twenty-four subjects were male (80%). The eosinophil concentration proximally and distally did not change significantly in either group post-treatment. The dysphagia score did improve significantly in both groups when comparing the baseline score to the week 16 (omalizumab group p<0.0001, placebo group p=0.02). However, the improvement in dysphagia score was not significant between groups (see table). The serum IgE level increased significantly in the omalizumab group between pre and post-treatment (p<0.0001) confirming drug effect. Conclusion: There was no improvement in the eosinophil infiltration with placebo or omalizumab treatment in EoE patients. Dysphagia scores improved similarly with both omalizumab and placebo. Omalizumab does not appear to be effective in the treatment of EoE. Results Table
Sa1141 Is Malignant Seeding of the Percutaneous Endoscopic Gastrostomy (PEG) Tract a Rare Complication?- A Prospective and Systematic Pilot Study Petr Sergueev, Mark Ellrichmann, Victor Kataev, Alexander Arlt, Perdita Wietzke-Braun, Theodoros Topalidis, Annette Fritscher-Ravens Introduction: Insertion of a percutaneous endoscopic gastrostomy (PEG) is a standard procedure in many patients with esophageal malignancies or cancers of the throat (ENT) to allow enteral feeding in connection with oncological treatment. During the endoscopic placement procedure, the tumors get into direct contact with the placement tube (PT) or the security plate. Development of metastases at PEG outlet sites at the abdominal wall, representing a late complication, has been reported in single cases throughout the world but is thought to represent a rare complication. But many of the patients might not live long enough to get to this late stage, so that the true seeding rate in unknown. As with modern treatment options the survival rates are improving, this information might be of importance. Aim: To prospectively and systematically evaluate the rate of malignant cell seeding at the abdominal wall pull-through site at the time of the PEG placement. Methods: This pilot study includes the first 15 consecutive cases of an overall of 50 intended patients with tumors, that allow direct contact with the placement tube during insertion. Standard pull-technique was used for PEG placement using a norm gastroscope. Immediately after the PEG procedure, brush cytology was taken from the PEG tubing as well as from the transcutaneous incision site. Results: 15 consecutive patients,13 with ENT tumors and 2 with esophageal cancers received a PEG without any complication. Subsequent cytology of the brushing of the tube and incision site proved malignant cells present on cytology in 4 of the 15 cases (27%) and none in the remaining 11. Both of the two esophageal cancers had produced seeding, while only 2/13 with ENT tumors showed malignancy at the abdominal wall on cytology. Conclusion: In this small series, the rate of malignant seeding was 27%. As oncological tumor treatment becomes more successful and patients may survive these cancers longer in the future it might be worth while considering to abandon the pull-through PEG tube technique and substitute it with a direct placement technique. It is noteworthy that both the two esophageal cancers produced seeding, which might hint at a higher rate of seeding of these tumors when compared with ENT cancers. However, these small numbers cannot provide sufficient data for this statement and the final study results might provide better insights into the spread of malignancies in relation to tumor etiologies. Sa1142 Prevention of Delayed Bleeding After Endoscopic Submucosal Dissection (ESD) for Gastric Tumors Yutaka Asakuma, Shigenaga Matsui, Masanori Kawasaki, Toshiharu Sakurai, Hiroshi Kashida, Masatoshi Kudo
Sa1144
Objective: Recently, the treatment of the early gastric cancer by endoscopic submucosal dissection (ESD) is becoming more and more popular and established. However, we sometimes experience several complications. Delayed bleeding is one of the major complications of ESD for gastric tumors. It is necessary to analyze the tendency and better measures for preventing delayed bleeding. We examined retrospectively the patient characteristics to search for the factor of the delayed bleeding after ESD for gastric tumor. Method: Three hundred thirty patients with gastric tumors (386 lesions) underwent ESD between August 1, 2002 and December 31, 2007. Delayed bleeding was defined as hematemesis or melena that required endoscopic hemostatic procedure or decreased the hemoglobin count by more than 2g/dl after ESD. We analyzed several factors such as the age, the sex, the tumor location,
The Role of GERD in Eosinophilic Esophagitis Dawn L. Francis, Amindra S. Arora, Kim L. Jensen, Sara Linker-Nord, Amy E. FoxxOrenstein Background: There is overlap between Eosinophilic Esophagitis (EoE) and GERD. Recent data suggest that the differentiation between GERD and EoE can not be made on density of eosinophilic infiltrate alone or by presence of GERD symptoms. As a result, the extent to which the diseases overlap has been difficult to ascertain and has not been objectively evaluated in a large prospective trial. We aimed to define the prevalence of GERD in patients
S-235
AGA Abstracts
AGA Abstracts
Sa1140