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Tu1210 Obesity and Swallowable Intragastric Balloon: A European Pilot Study
Tu1209 Analysis of 1001 Patients Submitted to Endoscopic Treatment of Excess Weight With an Intragastric Balloon Ricardo J. Fittipaldi-Fernandez, Cristina F. Diestel
AGA Abstracts
INTRODUCTION: Endoscopic methods, especially the intragastric balloon (IGB), have been shown to be effective for the treatment of excess weight. OBJECTIVE: To assess the efficacy and complications of excess weight treatment with an IGB in patients seen at the Endogastro Med Service clinic. METHODS: A total of 1001 patients were analyzed. An Allergan IGB (BIB®) with a volume of 600 to 700 ml was used. The patients had a minimum initial body mass index (BMI) of 27 kg/m2 and were followed up by a multidisciplinary team consisting of a nutritionist, a doctor and a psychologist. For statistical analysis, the patients were divided into groups according to sex and degree of excess weight (overweight and grade I, II and III obesity). Data were analyzed using descriptive statistical methods, the Student t-test, Spearman correlation, and analysis of variance followed by the Tukey post-test. The level of significance was set at p ,0.05. RESULTS: 43 patients were excluded from the analysis: 27 (2,69%) due to early IGB removal, 4 (0.39%) due to absence of weight loss, 2 (0.19%) due to weight gain, and 10 (0,99%) due to incomplete data. The incidence of fungus was 0.39% (n=4) and the incidence of leakage was 0.19% (n=2). Of the 958 remaining patients, 747 were women and 211 were men. Mean age was 37.33 years. The patients showed a significant weight loss, with a significantly lower final BMI (mean: 29.02±5.01 kg/m2; range: 19.79-47.03) than the initial BMI (mean: 36.94±5.43 kg/m2; range: 27.04-62.03) (p,0.0001). Mean BMI reduction was 7.92±2.83 kg/m2 (range: 1.70-17.09). Mean percent weight loss was 19.55±6.63% and mean percent excess weight loss was 70.88±38.56% (range: 11,35-339,03). There was no difference between BMI ranges regarding percent initial weight loss (p=0.5143) and there was no difference between men and women regarding BMI reduction (p=0.0944) or percent initial weight loss (p=0.8013). There was a positive correlation between the numbers of visits to a nutritionist and a greater loss of initial weight (p=0.0001). CONCLUSION: Endoscopic treatment of excess weight with an IGB has been established as an excellent therapeutic option for patients of both genders with overweight or different degrees of obesity. Tu1210 Obesity and Swallowable Intragastric Balloon: A European Pilot Study Francois Mion, Mostafa Ibrahim, Sophie Marjoux, Sonia Dugardeyn, Sabine Roman, Thierry Ponchon, Jacques M. Deviere
HRM, high resolution manometry; IQR, interquartile range.; LOS Lower oesophageal sphincter
Objectives Intragastric balloons allow transient weight loss in obese and overweight patients. The introduction in the stomach and their withdrawal involve iterative endoscopic procedures, usually under sedation or general anesthesia. We investigated the safety and efficacy of a new swallowable intragastric balloon (Obalon®) which can be placed without upper GI endoscopy and allows titration during the treatment period. Methods From January 2012 to April 2012, 17 patients (15 women, 39±9 years, BMI: 31±3 kg/m2) have been included in Brussels and Lyon. Ingestion of the balloon (inserted in a soluble capsule 30 x 15 mm, and connected to a detachable inflation-catheter of 2 Fr in diameter) was performed under fluoroscopic control, and the balloon inflated with 250 cc of gas once in place in the stomach. An additional balloon could be administered at 4 and 8 weeks depending on the tolerance and weight loss. Patients were under PPIs for the duration of the study. The balloons were endoscopically removed under sedation at 12 weeks. Results A balloon could be inserted in all patients; a second balloon was ingested by 16 patients (inability to swallow in 1) between 4 and 5 weeks after the first, and a 3rd balloon ingested between 7 and 9 weeks by 10 patients (no failures of ingestion). The mean time to insert the balloon (ingestion+ inflation) was 8 min (extreme: 4-18). No unexpected or serious adverse events occurred. Epigastric pain/cramping was the most common adverse event occurring in 12 (71%) subjects, 6 resolved without medical therapy, 6 with oral medical therapy and none required hospitalization. Nausea was also reported in 7 (41%) subjects. The endoscopic withdrawal of the balloons was done under sedation without tracheal intubation: the mean duration of the procedure was 14±6 minutes (range: 6-24 min). At the time of withdrawal, no balloon was spontaneously deflated, and no ulcerations were observed with the exception of 1 mild case, possibly unrelated to the device, in a subject who used NSAIDs. Weight loss compared to baseline was statistically significant (p , 0.0001) with a reduction (mean±SD) of 2.2±1.7 kg, 4.0±2.6 kg, 5.8±2.9 kg at 4, 8 and 12 weeks, respectively. Percent Excess Weight Loss was 15.7± 12.7%, 28.1±18.1%, 44.1±29.4% at 4, 8 and 12 weeks, respectively. Conclusions The data from this study demonstrate this new swallowable intragastric balloon to be safe and easy to administrate, well-tolerated and effective in terms of weight loss over a 12 week period.
Tu1208 Provocative Manometry With Postprandial Monitoring Enhances Diagnostic Yield in Patients With Intermittent Symptoms Victor Chedid, Sameer Dhalla, Monica Nandwani, Bani Chander Roland, John O. Clarke, Ellen M. Stein Background: High-resolution esophageal manometry (HREM) is the gold standard for evaluation of esophageal motility disorders. However, symptoms rarely occur during a monitored liquid swallow, especially when symptoms are intermittent. Recent literature supports use of provocative HREM protocols to more reliably induce symptoms and assess motility when "under duress." Our protocol involves patients bringing a meal to be eaten while undergoing prolonged monitoring during and after meal ingestion. We hypothesized that this would provoke symptoms and increase diagnostic yield. Aims: The aims of our study were to determine whether 1) the addition of dedicated postprandial monitoring enhanced diagnostic yield in patients with intermittent symptoms, and whether 2) a 30-minute postprandial monitoring period was sufficient to capture symptoms in the majority of referred patients. Methods: Consecutive patients who underwent HREM with postprandial monitoring at a single academic referral center from January to October 2012 were reviewed. Demographics, initial diagnosis, final diagnosis, number of symptoms, and changes in management were recorded. Patients were encouraged to bring a meal of their choice which would be likely to produce symptoms. All patients underwent standard HREM with 10 liquid swallows. The meal was then ingested while the HREM catheter remained in position for 30 minutes. All symptoms were noted. Results: Out of 458 patients who underwent HREM during the study period, 15 patients (mean age= 52.9, range= 25-80, Females=66.7%) were referred specifically for HREM with extended postprandial monitoring. Indications were: refractory belching (6), atypical GERD (3), regurgitation (3), and intermittent dysphagia (3). Ten of the 15 patients recorded symptoms (belching, dysphagia or chest pressure) during the 30 minute monitoring period. The number of symptoms provoked ranged from 0 to "innumerable" with a median value of 5. Six of the 15 patients had new manometric findings after meal ingestion, that were not evident when taking only liquid swallows, with subsequent changes in both diagnoses and management. New diagnoses detected with dedicated postprandial monitoring included rumination, supragastric belching, gastric belching, and diffuse esophageal spasm. Conclusion: HREM with extended postprandial monitoring enhanced diagnostic yield as compared to conventional HREM. Postprandial monitoring should be considered in patients with intermittent symptoms such as dysphagia or belching, where symptomatic provocation is desired to assure complete evaluation, or in patients for whom rumination is suspected. Thirty minutes appears to be an adequate duration to allow symptom genesis. Prospective evaluation will help determine which subset of symptoms has highest diagnostic yield with this protocol.
AGA Abstracts
Tu1211 Endoscopic Treatment of Post Laparoscopic Sleeve Gastrectomy Fistula : Results From a Multicenter Retrospective Study Dimitri Christophorou, Natalie Funakoshi, Jean-Christophe Valats, Bruno Vedrenne, Frederic Prat, Philippe Bulois, Vincent Maunoury, Sebastien Decoster, Emmanuel Coron, Claire Duflos, Marie-Christine Picot, David Nocca, Paul Bauret, Pierre Blanc Introduction Laparoscopic Sleeve Gastrectomy (LSG) is the most frequently performed bariatric surgery procedure in France. Staple line leak is the main complication, for which healing is difficult to obtain. Aims: To evaluate the effectiveness of endoscopic treatment in the repair of staple line leaks, to describe the various endoscopic techniques used, to identify the predictive factors of healing following endoscopic management. Methods Patients with LSG staple line leaks were included in a multicenter retrospective cohort. Data was collected on therapeutic procedures performed (endoscopic or surgical), treatment complications and time to healing (spontaneous, or following endoscopic or surgical treatment). Predictive factors of healing after endoscopic treatment were evaluated in univariate analysis by a Logrank test, then in a multivariate analysis using a Cox model. The protocol was approved by the research and development committee of the French Digestive Endoscopy Society. Results 104 patients with leaks (83% females, mean age 39.6 years, mean BMI 44.3 kg/m2)
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AGA Abstracts
INTRODUCTION: Endoscopic methods, especially the intragastric balloon (IGB), have been shown to be effective for the treatment of excess weight. OBJECTIVE: To assess the efficacy and complications of excess weight treatment with an IGB in patients seen at the Endogastro Med Service clinic. METHODS: A total of 1001 patients were analyzed. An Allergan IGB (BIB®) with a volume of 600 to 700 ml was used. The patients had a minimum initial body mass index (BMI) of 27 kg/m2 and were followed up by a multidisciplinary team consisting of a nutritionist, a doctor and a psychologist. For statistical analysis, the patients were divided into groups according to sex and degree of excess weight (overweight and grade I, II and III obesity). Data were analyzed using descriptive statistical methods, the Student t-test, Spearman correlation, and analysis of variance followed by the Tukey post-test. The level of significance was set at p ,0.05. RESULTS: 43 patients were excluded from the analysis: 27 (2,69%) due to early IGB removal, 4 (0.39%) due to absence of weight loss, 2 (0.19%) due to weight gain, and 10 (0,99%) due to incomplete data. The incidence of fungus was 0.39% (n=4) and the incidence of leakage was 0.19% (n=2). Of the 958 remaining patients, 747 were women and 211 were men. Mean age was 37.33 years. The patients showed a significant weight loss, with a significantly lower final BMI (mean: 29.02±5.01 kg/m2; range: 19.79-47.03) than the initial BMI (mean: 36.94±5.43 kg/m2; range: 27.04-62.03) (p,0.0001). Mean BMI reduction was 7.92±2.83 kg/m2 (range: 1.70-17.09). Mean percent weight loss was 19.55±6.63% and mean percent excess weight loss was 70.88±38.56% (range: 11,35-339,03). There was no difference between BMI ranges regarding percent initial weight loss (p=0.5143) and there was no difference between men and women regarding BMI reduction (p=0.0944) or percent initial weight loss (p=0.8013). There was a positive correlation between the numbers of visits to a nutritionist and a greater loss of initial weight (p=0.0001). CONCLUSION: Endoscopic treatment of excess weight with an IGB has been established as an excellent therapeutic option for patients of both genders with overweight or different degrees of obesity. Tu1210 Obesity and Swallowable Intragastric Balloon: A European Pilot Study Francois Mion, Mostafa Ibrahim, Sophie Marjoux, Sonia Dugardeyn, Sabine Roman, Thierry Ponchon, Jacques M. Deviere
HRM, high resolution manometry; IQR, interquartile range.; LOS Lower oesophageal sphincter
Objectives Intragastric balloons allow transient weight loss in obese and overweight patients. The introduction in the stomach and their withdrawal involve iterative endoscopic procedures, usually under sedation or general anesthesia. We investigated the safety and efficacy of a new swallowable intragastric balloon (Obalon®) which can be placed without upper GI endoscopy and allows titration during the treatment period. Methods From January 2012 to April 2012, 17 patients (15 women, 39±9 years, BMI: 31±3 kg/m2) have been included in Brussels and Lyon. Ingestion of the balloon (inserted in a soluble capsule 30 x 15 mm, and connected to a detachable inflation-catheter of 2 Fr in diameter) was performed under fluoroscopic control, and the balloon inflated with 250 cc of gas once in place in the stomach. An additional balloon could be administered at 4 and 8 weeks depending on the tolerance and weight loss. Patients were under PPIs for the duration of the study. The balloons were endoscopically removed under sedation at 12 weeks. Results A balloon could be inserted in all patients; a second balloon was ingested by 16 patients (inability to swallow in 1) between 4 and 5 weeks after the first, and a 3rd balloon ingested between 7 and 9 weeks by 10 patients (no failures of ingestion). The mean time to insert the balloon (ingestion+ inflation) was 8 min (extreme: 4-18). No unexpected or serious adverse events occurred. Epigastric pain/cramping was the most common adverse event occurring in 12 (71%) subjects, 6 resolved without medical therapy, 6 with oral medical therapy and none required hospitalization. Nausea was also reported in 7 (41%) subjects. The endoscopic withdrawal of the balloons was done under sedation without tracheal intubation: the mean duration of the procedure was 14±6 minutes (range: 6-24 min). At the time of withdrawal, no balloon was spontaneously deflated, and no ulcerations were observed with the exception of 1 mild case, possibly unrelated to the device, in a subject who used NSAIDs. Weight loss compared to baseline was statistically significant (p , 0.0001) with a reduction (mean±SD) of 2.2±1.7 kg, 4.0±2.6 kg, 5.8±2.9 kg at 4, 8 and 12 weeks, respectively. Percent Excess Weight Loss was 15.7± 12.7%, 28.1±18.1%, 44.1±29.4% at 4, 8 and 12 weeks, respectively. Conclusions The data from this study demonstrate this new swallowable intragastric balloon to be safe and easy to administrate, well-tolerated and effective in terms of weight loss over a 12 week period.
Tu1208 Provocative Manometry With Postprandial Monitoring Enhances Diagnostic Yield in Patients With Intermittent Symptoms Victor Chedid, Sameer Dhalla, Monica Nandwani, Bani Chander Roland, John O. Clarke, Ellen M. Stein Background: High-resolution esophageal manometry (HREM) is the gold standard for evaluation of esophageal motility disorders. However, symptoms rarely occur during a monitored liquid swallow, especially when symptoms are intermittent. Recent literature supports use of provocative HREM protocols to more reliably induce symptoms and assess motility when "under duress." Our protocol involves patients bringing a meal to be eaten while undergoing prolonged monitoring during and after meal ingestion. We hypothesized that this would provoke symptoms and increase diagnostic yield. Aims: The aims of our study were to determine whether 1) the addition of dedicated postprandial monitoring enhanced diagnostic yield in patients with intermittent symptoms, and whether 2) a 30-minute postprandial monitoring period was sufficient to capture symptoms in the majority of referred patients. Methods: Consecutive patients who underwent HREM with postprandial monitoring at a single academic referral center from January to October 2012 were reviewed. Demographics, initial diagnosis, final diagnosis, number of symptoms, and changes in management were recorded. Patients were encouraged to bring a meal of their choice which would be likely to produce symptoms. All patients underwent standard HREM with 10 liquid swallows. The meal was then ingested while the HREM catheter remained in position for 30 minutes. All symptoms were noted. Results: Out of 458 patients who underwent HREM during the study period, 15 patients (mean age= 52.9, range= 25-80, Females=66.7%) were referred specifically for HREM with extended postprandial monitoring. Indications were: refractory belching (6), atypical GERD (3), regurgitation (3), and intermittent dysphagia (3). Ten of the 15 patients recorded symptoms (belching, dysphagia or chest pressure) during the 30 minute monitoring period. The number of symptoms provoked ranged from 0 to "innumerable" with a median value of 5. Six of the 15 patients had new manometric findings after meal ingestion, that were not evident when taking only liquid swallows, with subsequent changes in both diagnoses and management. New diagnoses detected with dedicated postprandial monitoring included rumination, supragastric belching, gastric belching, and diffuse esophageal spasm. Conclusion: HREM with extended postprandial monitoring enhanced diagnostic yield as compared to conventional HREM. Postprandial monitoring should be considered in patients with intermittent symptoms such as dysphagia or belching, where symptomatic provocation is desired to assure complete evaluation, or in patients for whom rumination is suspected. Thirty minutes appears to be an adequate duration to allow symptom genesis. Prospective evaluation will help determine which subset of symptoms has highest diagnostic yield with this protocol.
AGA Abstracts
Tu1211 Endoscopic Treatment of Post Laparoscopic Sleeve Gastrectomy Fistula : Results From a Multicenter Retrospective Study Dimitri Christophorou, Natalie Funakoshi, Jean-Christophe Valats, Bruno Vedrenne, Frederic Prat, Philippe Bulois, Vincent Maunoury, Sebastien Decoster, Emmanuel Coron, Claire Duflos, Marie-Christine Picot, David Nocca, Paul Bauret, Pierre Blanc Introduction Laparoscopic Sleeve Gastrectomy (LSG) is the most frequently performed bariatric surgery procedure in France. Staple line leak is the main complication, for which healing is difficult to obtain. Aims: To evaluate the effectiveness of endoscopic treatment in the repair of staple line leaks, to describe the various endoscopic techniques used, to identify the predictive factors of healing following endoscopic management. Methods Patients with LSG staple line leaks were included in a multicenter retrospective cohort. Data was collected on therapeutic procedures performed (endoscopic or surgical), treatment complications and time to healing (spontaneous, or following endoscopic or surgical treatment). Predictive factors of healing after endoscopic treatment were evaluated in univariate analysis by a Logrank test, then in a multivariate analysis using a Cox model. The protocol was approved by the research and development committee of the French Digestive Endoscopy Society. Results 104 patients with leaks (83% females, mean age 39.6 years, mean BMI 44.3 kg/m2)
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