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Mo1298 One-Year Response Rate to Gastric Electrical Stimulation in Patients Selected for Treatment by Temporary Percutaneous Gastric Electrical Stimulation
AGA Abstracts
Results expressed as mean±SEM Figure 1. Endoscopic image of EndoFLIP catheter balloon in the pylorus at 50cc balloon volume distension.
Mo1298 One-Year Response Rate to Gastric Electrical Stimulation in Patients Selected for Treatment by Temporary Percutaneous Gastric Electrical Stimulation Hans Törnblom, Serta Kilincalp, Gisela Ringstrom, Magnus Simren, Hasse Abrahamsson Background: Gastric electrical stimulation (GES) with the Enterra system is an approved treatment for severe nausea and vomiting secondary to diabetic or idiopathic gastroparesis (GP). Some patients with normal gastric emptying also benefit from GES to treat severe nausea and vomiting (Andersson et al, 2011). Aim: To evaluate the one-year response to permanent GES treatment in patients with nausea and vomiting secondary to other diagnoses than diabetic GP after an attempted blinded temporary GES period as a selection tool. Methods: We used a temporary percutaneous GES (TPGES) technique described by us previously (Elfvin et al, 2007) in a randomized double-blind cross-over design with 1-2 weeks stimulation ON (5-7 mA range) followed by stimulation OFF, or the opposite order. Only patients where a blinded stimulation period was possible to achieve were included in the current follow-up analysis. Treatment response was defined as a symptom reduction ≥50% during the ON period compared to the OFF period for one or both of weekly nausea hours (WNH) and weekly vomiting frequency (WVF). Non-responders to blinded TPGES were offered an open treatment period with increased stimulation (5-10 mA as tolerated). The response to permanent GES was judged by the same response definition but comparing one-year data with baseline symptom registration before TPGES treatment. Results: We included 27 patients (22 females; median age 47 years, range 21-70 years). In total, 19 patients (70%) were responders to TPGES (11 patients (41%) after blinded stimulation, 8 patients (30%) after open stimulation). Eighteen patients accepted implantation of a permanent GES device with clinical diagnosis and gastric emptying status as shown in table 1. At one year follow up, 12 (67%) were still responders to GES, while 4 (22%) were nonresponders. Two (11%) patients had incomplete symptom questionnaire data for evaluation, but one of them had a definite subjective positive response. Seven (88%) of those selected by an open TPGES response were one-year responders to permanent GES. Coexisting gastroparesis did not affect the response rate (p=.16). Response in relation to clinical diagnosis and gastric emptying status is shown in table 1. At the one year evaluation, apart from significant reductions in WVF and WNH, there was also a significant reduction in symptom scores for early satiety (p=.03) and bloating (p=.04) and a trend for reduced abdominal pain (p=.09) and improved global well-being (p=.11) Conclusion: TPGES as a selection tool for permanent GES in patients without diabetic GP yields at least a 70% positive one-year response. The predictive value does not seem to be negatively affected by selection from open TPGES with increased impulse strength, as opposed to selection after blinded stimulation in an ON-OFF fashion. Table 1. Clinical diagnosis, gastric emptying status and one year response number in patients selected for permanent GES
Figure 2. EndoFLIP image of the pylorus at 40 cc balloon volume distension. Mo1297 Symptoms of Nausea and Postprandial Fullness Improve in Gastroparetic Patients Receiving Botulinum Toxin a Injection Into the Pylorus Zubair A. Malik, Henry P. Parkman Gastroparesis is a disorder defined by symptoms and delayed gastric emptying. Previous open label studies have shown some improvement in symptoms and gastric emptying after botulinum neurotoxin A (BoNT/A) injections to the pylorus. However, placebo-controlled studies showed similar responses in composite symptoms of gastroparesis to BoNT/A and placebo. BoNT/A may have an effect on specific symptoms of gastroparesis which might not have been carefully assessed in previous studies. The aim of this study was to determine which, if any, specific symptoms improve after BoNT/A injection in patients with gastroparesis. Methods: 16 patients with gastroparesis (14 female, 7 diabetic) underwent BoNT/A injection in the pylorus for treatment of their refractory symptoms. 200 International Units (IU) BoNT/A (Botox; Allergan, Inc) was injected into the pylorus (5 injections of 20 IU per injection). Before and at 2 and 4 weeks after treatment, patients were asked about their primary symptom of gastroparesis, as well as the severity of nausea, upper abdominal pain, stomach fullness, loss of appetite, bloating, retching, vomiting, stomach visibly larger, not able to finish a normal size meal, and feeling excessively full after meals rating their symptoms over the prior 2 weeks from 0 (none) to 5 (very severe) (using the GCSI). In followup, patients were asked to assess their therapeutic response using the Clinical Patient Grading Assessment Scale (CPGAS; +7=completely better; 0=no change; -7=very considerably worse). Results expressed as mean±SEM. Results: 16 patients received BoNT/A: 9 (56%) stated they improved overall, 4 were unchanged, and 3 worsened. Overall, the change in the CPGAS was +0.50±1.09. There were significant improvements in nausea from prior to BoNT/A (4.0±0.4) to week 4 (2.7±0.4) (p=0.030) and in feeling of excessive fullness after meals (4.8±0.1 to 4.0±0.3; p=0.043) (see table). The main symptoms of the patients prior to treatment were: nausea in 5 (all 5 improved), vomiting in 1 (improved), retching in 1 (0 improved), abdominal pain in 7 (2 improved), and bloating in 2 (0 improved). No significant difference was seen between idiopathic and diabetic gastroparetics. Conclusions: In this open label study, BoNT/A injections to the pylorus in patients with gastroparesis improved nausea and excessive fullness after meals. Overall improvement was reported in 56% of these refractory patients. This study suggests that patients with predominantly nausea and/ or postprandial fullness may benefit from BoNT/A injections while those with other primary symptoms, such as abdominal pain and bloating, will not. Individual symptom scores may better indicate the response to BoNT/A than composite symptoms in patients with gastroparesis. Double blind studies should assess the efficacy of BoNT/A injection of the pylorus on nausea and postprandial fullness. Table. Symptom severity before and after treatment with botulinum toxin injection
AGA Abstracts
Mo1299 Is Gastroparesis Protective of Hypoglycemia in Type 2 Diabetics? Linda Anh B. Nguyen, Ajitha Mannalithara, Alka Sehgal, Uri Ladabaum, Gurkirpal Singh Background: Approximately 30-50% of patients with longstanding diabetes have gastroparesis. Diabetic gastroparesis has been associated with impaired glycemic control. Moreover, insulin treated patients with hypoglycemia are more likely to have gastroparesis than those without hypoglycemia. Aim: The aim of our study is to determine the impact of gastroparesis on hypoglycemia in patients with Type 2 diabetes (T2DM). Methods: We examined the National Ambulatory Medical Care Survery (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) to study the relationship between hypoglycemia and gastroparesis in patients with T2DM. The NAMCS and NHAMCS are national surveys designed to collect reliable and accurate data on ambulatory care in physician offices (NAMCS), emergency departments and hospital outpatient facilities (NHAMCS), irrespective of insurance status. These databases cover a representative portion of the US population. We evaluated all medical encounters in 2008 with a primary or secondary diagnosis of T2DM,
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Results expressed as mean±SEM Figure 1. Endoscopic image of EndoFLIP catheter balloon in the pylorus at 50cc balloon volume distension.
Mo1298 One-Year Response Rate to Gastric Electrical Stimulation in Patients Selected for Treatment by Temporary Percutaneous Gastric Electrical Stimulation Hans Törnblom, Serta Kilincalp, Gisela Ringstrom, Magnus Simren, Hasse Abrahamsson Background: Gastric electrical stimulation (GES) with the Enterra system is an approved treatment for severe nausea and vomiting secondary to diabetic or idiopathic gastroparesis (GP). Some patients with normal gastric emptying also benefit from GES to treat severe nausea and vomiting (Andersson et al, 2011). Aim: To evaluate the one-year response to permanent GES treatment in patients with nausea and vomiting secondary to other diagnoses than diabetic GP after an attempted blinded temporary GES period as a selection tool. Methods: We used a temporary percutaneous GES (TPGES) technique described by us previously (Elfvin et al, 2007) in a randomized double-blind cross-over design with 1-2 weeks stimulation ON (5-7 mA range) followed by stimulation OFF, or the opposite order. Only patients where a blinded stimulation period was possible to achieve were included in the current follow-up analysis. Treatment response was defined as a symptom reduction ≥50% during the ON period compared to the OFF period for one or both of weekly nausea hours (WNH) and weekly vomiting frequency (WVF). Non-responders to blinded TPGES were offered an open treatment period with increased stimulation (5-10 mA as tolerated). The response to permanent GES was judged by the same response definition but comparing one-year data with baseline symptom registration before TPGES treatment. Results: We included 27 patients (22 females; median age 47 years, range 21-70 years). In total, 19 patients (70%) were responders to TPGES (11 patients (41%) after blinded stimulation, 8 patients (30%) after open stimulation). Eighteen patients accepted implantation of a permanent GES device with clinical diagnosis and gastric emptying status as shown in table 1. At one year follow up, 12 (67%) were still responders to GES, while 4 (22%) were nonresponders. Two (11%) patients had incomplete symptom questionnaire data for evaluation, but one of them had a definite subjective positive response. Seven (88%) of those selected by an open TPGES response were one-year responders to permanent GES. Coexisting gastroparesis did not affect the response rate (p=.16). Response in relation to clinical diagnosis and gastric emptying status is shown in table 1. At the one year evaluation, apart from significant reductions in WVF and WNH, there was also a significant reduction in symptom scores for early satiety (p=.03) and bloating (p=.04) and a trend for reduced abdominal pain (p=.09) and improved global well-being (p=.11) Conclusion: TPGES as a selection tool for permanent GES in patients without diabetic GP yields at least a 70% positive one-year response. The predictive value does not seem to be negatively affected by selection from open TPGES with increased impulse strength, as opposed to selection after blinded stimulation in an ON-OFF fashion. Table 1. Clinical diagnosis, gastric emptying status and one year response number in patients selected for permanent GES
Figure 2. EndoFLIP image of the pylorus at 40 cc balloon volume distension. Mo1297 Symptoms of Nausea and Postprandial Fullness Improve in Gastroparetic Patients Receiving Botulinum Toxin a Injection Into the Pylorus Zubair A. Malik, Henry P. Parkman Gastroparesis is a disorder defined by symptoms and delayed gastric emptying. Previous open label studies have shown some improvement in symptoms and gastric emptying after botulinum neurotoxin A (BoNT/A) injections to the pylorus. However, placebo-controlled studies showed similar responses in composite symptoms of gastroparesis to BoNT/A and placebo. BoNT/A may have an effect on specific symptoms of gastroparesis which might not have been carefully assessed in previous studies. The aim of this study was to determine which, if any, specific symptoms improve after BoNT/A injection in patients with gastroparesis. Methods: 16 patients with gastroparesis (14 female, 7 diabetic) underwent BoNT/A injection in the pylorus for treatment of their refractory symptoms. 200 International Units (IU) BoNT/A (Botox; Allergan, Inc) was injected into the pylorus (5 injections of 20 IU per injection). Before and at 2 and 4 weeks after treatment, patients were asked about their primary symptom of gastroparesis, as well as the severity of nausea, upper abdominal pain, stomach fullness, loss of appetite, bloating, retching, vomiting, stomach visibly larger, not able to finish a normal size meal, and feeling excessively full after meals rating their symptoms over the prior 2 weeks from 0 (none) to 5 (very severe) (using the GCSI). In followup, patients were asked to assess their therapeutic response using the Clinical Patient Grading Assessment Scale (CPGAS; +7=completely better; 0=no change; -7=very considerably worse). Results expressed as mean±SEM. Results: 16 patients received BoNT/A: 9 (56%) stated they improved overall, 4 were unchanged, and 3 worsened. Overall, the change in the CPGAS was +0.50±1.09. There were significant improvements in nausea from prior to BoNT/A (4.0±0.4) to week 4 (2.7±0.4) (p=0.030) and in feeling of excessive fullness after meals (4.8±0.1 to 4.0±0.3; p=0.043) (see table). The main symptoms of the patients prior to treatment were: nausea in 5 (all 5 improved), vomiting in 1 (improved), retching in 1 (0 improved), abdominal pain in 7 (2 improved), and bloating in 2 (0 improved). No significant difference was seen between idiopathic and diabetic gastroparetics. Conclusions: In this open label study, BoNT/A injections to the pylorus in patients with gastroparesis improved nausea and excessive fullness after meals. Overall improvement was reported in 56% of these refractory patients. This study suggests that patients with predominantly nausea and/ or postprandial fullness may benefit from BoNT/A injections while those with other primary symptoms, such as abdominal pain and bloating, will not. Individual symptom scores may better indicate the response to BoNT/A than composite symptoms in patients with gastroparesis. Double blind studies should assess the efficacy of BoNT/A injection of the pylorus on nausea and postprandial fullness. Table. Symptom severity before and after treatment with botulinum toxin injection
AGA Abstracts
Mo1299 Is Gastroparesis Protective of Hypoglycemia in Type 2 Diabetics? Linda Anh B. Nguyen, Ajitha Mannalithara, Alka Sehgal, Uri Ladabaum, Gurkirpal Singh Background: Approximately 30-50% of patients with longstanding diabetes have gastroparesis. Diabetic gastroparesis has been associated with impaired glycemic control. Moreover, insulin treated patients with hypoglycemia are more likely to have gastroparesis than those without hypoglycemia. Aim: The aim of our study is to determine the impact of gastroparesis on hypoglycemia in patients with Type 2 diabetes (T2DM). Methods: We examined the National Ambulatory Medical Care Survery (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) to study the relationship between hypoglycemia and gastroparesis in patients with T2DM. The NAMCS and NHAMCS are national surveys designed to collect reliable and accurate data on ambulatory care in physician offices (NAMCS), emergency departments and hospital outpatient facilities (NHAMCS), irrespective of insurance status. These databases cover a representative portion of the US population. We evaluated all medical encounters in 2008 with a primary or secondary diagnosis of T2DM,
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