AGA Abstracts
indirect effect (2%) mediated by increasing a patient's CSBM rate (Figure 1). Spontaneous bowel movements (SBMs) that were not associated with a sense of completeness and BMs associated with rescue medication use did not qualitatively increase the amount of mediated LIN pain effect. The results of the 2-way CSBM stratification analysis (Table 1) indicated that improvement in abdominal pain was influenced by the time since last CSBM and the number of recent CSBMs. However, consistent with the predominant direct effect of LIN on abdominal pain shown in the mediation analysis, in each cell of Table 1, the LIN-treated patients had greater abdominal pain relief than PBO-treated patients when controlling for these CSBM factors. Conclusions: The results of these analyses are consistent with the hypothesis that the LIN effect on abdominal pain (over PBO) was predominantly a direct effect and, to a lesser extent, a mediated effect of increasing CSBM frequency. Table 1. Percent Improvement in Abdominal Pain Stratified by Number of Recent CSBMs and Time Since Last CSBM by Treatment Group (LIN/PBO [LIN-PBO difference])
treatment. However, these reports need to be interpreted with caution in tropical countries, in view of morphological differences in the intestinal mucosa, high prevalence of intestinal parasitic infestations and uniqueness in the composition of intestinal microbiota reported in previous studies. AIMS AND OBJECTIVES: To compare the efficacy of oral versus intramuscular vitamin B12 supplementation for the treatment of vitamin B12 deficiency MATERIALS AND METHOD: Consecutive patients with vitamin B12 deficiency (serum vitamin B12 level <200pg/ml) attending a tertiary care hospital in south India from November 2009 to November 2010 were randomized and allocated in a concealed manner into oral (1000μg of vitamin B12 daily for 3 months) and intramuscular (1000μg of vitamin B12 once daily for a week followed by once a week for 8 weeks) treatment groups in 1:1 ratio. Patients aged <18 years, pregnant individuals, those with special conditions mandating parenteral supplementation and those who were already on vitamin B12 supplements were excluded. Sample size was estimated to be 23 in each study arm, assuming equal response of 90% and non inferiority margin of 25% (α = 0.25, 1-β= 80%). The participants were followed up for 3 months after initiation of therapy. The primary outcome was normalization of serum vitamin B12 level ( ≥200pg/ml) at the end of follow up period. Compliance was ensured by pill/ampoule count and verification of injection records. An intention to treat analysis was done in a blinded fashion assuming lack of response for the patients who did not complete the study. The study was approved by the institutional review board and has been registered in the clinical trial registry of India. RESULTS: The flow of study participants is shown in figure 1. Baseline characteristics of the study groups were similar (table 1). 60 patients (44male,16 female) were randomized into oral and intramuscular treatment groups. 27 patients in the intramuscular group and 20 patients in the oral group achieved normalization of serum vitamin B12 level following treatment. The difference in treatment response was not statistically significant (p=0.06). CONCLUSIONS: Oral vitamin B12 supplementation is as effective as intramuscular treatment for vitamin B12 deficiency. Baseline Characteristics
ITT Population, Weeks 13-26, median values presented. For patients with multiple values in a particular cell, the patient's median value was used.
Sa1099 Clinical Studies of Gastrectomy for Gastric Cancer in Patients Over 80 Years Old Kiyoshi Kawaguchi, Keiji Ohta, Nobuo Seo, Masahiro Urayama, Ryo Toya Purpose: We examined the safety and the significance of gastrectomy for gastric cancer in patients over 80 years old. Methods: We retrospectively compared the results between 100 patients over 80 years old who underwent gastrectomy for gastric cancer from 1994 to 2010 and 108 patients (older-group) early 70s old who underwent gastrectomy during same period (younger-group), focusing on clinicopathological findings, preoperative complication, postoperative complication and postoperative prognosis. Results: Comparing older versus younger-group, there was no significant difference in cancer-stage, operative procedure, and the degree of lymph-node dissection. Concerning preoperative complication, the number of patients with cardiac disease and received anticoagulants were significantly higher in older group (29% for older-group vs. 13% for younger-group, p<0.01). Whereas we performed same lymph-node dissection for patients in both groups, there was no significant difference of postoperative surgical site complication. About nonsurgical complication, the rate of postoperative delirium was significantly higher for older-group (34% for older-group vs. 20% for younger-group, p=0.02). But these cases with postoperative delirium were improved in a few days. There was only one operational death of preoperative gastric cancer perforation case in over 80 year old group. Comparing prognosis of different Stage, the overall survival for over 80 was significantly worse in Stage IA (5-year survival: 68% for older-group vs. 95% for younger-group, p<0.01), because the causes of death were other disease in all cases. Disease-specific survival was not different in both groups. In over 80 year old group, there were few patients who seemed to accelerate senile. Conclusions: Although the rate of preoperative complication of older-group was higher than youngergroup, morbidity and mortality were same in both groups except for postoperative delirium. But there was possibility that early gastric cancer patients cannot live out their average life expectancy. And the result of palliative gastrectomy fell short of expectation.
Flow of study participants Sa1101 Fat-Free Nutritional Supplement is More Suitable for Preoperative Conditioning Than Standard Nutrient Due to Rapid Gastric Emptying Takatsugu Yamamoto, Tadahisa Ebato, Koichiro Abe, Hajime Anjiki, Mizue Tamura, Taro Ishii, Yasushi Kuyama Backgrounds: Preoperative conditioning with oral fluid and carbohydrate loading is reported as associated with reduced postoperative insulin resistance and early postoperative recovery. Further benefit may be expected from oral nutritional supplements. However, if contents exist in the stomach at the time of anesthesia, risk for pneumonia rises. It is clinically important to confirm gastric emptying of nutrients with different contents. We conducted the present study to assess the difference of gastric emptying between a nutritional supplement without fat contents and standard nutritional supplement including fat contents. Methods: Eight healthy volunteers who have neither past history of gastrointestinal surgery, medications, nor symptoms were enrolled as participants. After an overnight fast, participants drunk either 200ml of fat-free nutritional supplements (Peptino®, Terumo, Tokyo, Japan; carbohydrates 42.8g, protein 7.2g, 200kcal/200ml), nutrient with fat content (F2α®, Terumo, Tokyo, Japan; carbohydrates 31.0g, fat 4.4g, protein 10g, 200kcal/200ml), or water containing 100mg 13C-acetate within 5 min, and breath samples were collected every 15 min for 2.0 h. The half emptying time (T1/2) were calculated as conventional parameters using Wagner-Nelson method as below. The WN equation is F(t) = (A(breath)(t) + C(t)/ 0.65)/A(breath)(infinity), where F(t) is a fractional dose of the [(13)C] label emptied, C(t) is the [(13)CO(2)] excretion (% dose/h), A(breath)(t) is the area under the C(t) curve (% dose) and A(breath)(infinity) is the ultimate [(13)CO(2)] recovery in breath (% dose). The percentage gastric retention was estimated as 100 x (1 - F(t)), and T1/2 was calculated. Results: Gastric emptying of fat-free nutrients was significantly faster than fat-containing
Sa1100 Randomized Open Label Trial Comparing Efficacy of Oral Versus Intramuscular Vitamin B12 Supplementation for Treatment of Vitamin B12 Deficiency Arun Ramaswamy Saraswathy, Amit Dutta, Ebby G. Simon, Ashok Chacko BACKGROUND: The widely practised treatment of vitamin B12 deficiency is intramuscular vitamin B12 supplementation, which has implications on cost and convenience, in addition to injection related complications. Recent data from western countries suggest that high dose oral vitamin B12 supplementation may be an equally effective alternative to intramuscular
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nutrients (T1/2; 18.2 min vs. 30.8 min, p<0.05) and similar to that of water (T1/2; 18.2 min vs. 14.4 min, n.s ). Conclusion: The present study indicates that gastric emptying of fat-free nutrient is faster than fat-containing nutrients. To use as preoperative conditioning, fat-free nutrients seem safe and suitable.
AGA Abstracts
Sa1102 Refractory Anemia Due to Pyridoxine Deficiency in Patients With Crohn's Disease or Cirrhosis Veena Nannegari, Eugenia Tsai, Peter Ells, Catherine Bartholomew, Richard P. MacDermott, Esteban Mezey, Xinjun Zhu Background/Aims: Pyridoxine or vitamin B6 deficiency is an established cause of sideroblastic anemia through the inhibition of heme synthesis. Reduced levels of this micronutrient has also been implicated in sickle cell anemia and anemia of pregnancy. In 1984, Diehl et al demonstrated an association between low serum alanine transaminase (ALT) and pyridoxine deficiency. The correlation between decreased pyridoxine and serum ALT level can therefore serve as a tool to identify patients with microcytic anemia associated with pyridoxine deficiency. Malabsorption is a prominent cause of pyridoxine deficiency, which is frequent in patients with IBD. Similarly, patients with cirrhosis suffer from defects in vitamin metabolism and thus are also susceptible to pyridoxine deficiency. We conducted a prospective study to identify pyridoxine deficiency in these patients using low ALT values as a marker of B6 deficiency. We theorize that supplementation with pyridoxine will correct the anemia. Methods: Patients with anemia who had either cirrhosis or Crohn's disease at Albany Medical Center and some from Johns Hopkins Hospital were identified. Of the 203 patients with Crohn's disease and 202 patients with cirrhosis, 29 and 33 patients, respectively, met the inclusion criteria and were incorporated into this study. Inclusion criteria were hematocrit < 36 g/dL, mean corpuscular volume (MCV) < 80, total iron < 30 ug/dL, and ALT < 25 IU/ L. Patients with folate deficiency or vitamin B12 deficiency were excluded from the study. Results: All eligible patients were contacted by letters or telephone calls. Preliminary results from the first 8 patients with microcytic anemia refractory to iron supplementation revealed low serum ALT and lower than normal plasma pyridoxine levels. These patients were prescribed 50 mg of oral pyridoxine to be taken daily. A repeat pyridoxine level, complete blood count, and iron studies were redrawn at the end of 2 months of treatment to evaluate for improvement in anemia. Of those 8 patients, six patients have completed treatment with improvement in hematocrit, ALT and pyridoxine levels. The remainig patients from both groups continue to be investigated. Conclusions: Persistent anemia unresponsive to iron supplementation associated with low ALT level may be due to pyridoxine deficiency in malnourished patients with chronic gastrointestinal or liver disease.
Sa1104 Medical Doctors Trained in Biopsychosocial Medicine Improve the Satisfaction of IBS Patients Dan Lucian Dumitrascu, Adriana Baban Background and aim: IBS pts are usually unhappy and show poor response to therapy. Their care requires a comprehensive approach. We looked for the ability of MDs who followed a training in bioppsychosocial medicine (BPS) to care IBS pts compared to MDs not familiarized with the BPS model. Material-methods: We evaluated 120 consecutive IBS pts referred to a tertiary center, diagnosed according to Rome III criteria. They were referred from MDs who followed courses on BPS in a specialized university center (Group A) or who were not trained in BPS (Group B). Pts were evaluated for the symptom intensity and frequency (symptom score 0-16); anxiety (STAI) and QoL (SF-36); satisfaction with the medical care (structured interview, assessment scale 1-10); time offered by MD; knowledge on IBS; adherence (all these evaluated by a structured interview, assessment scale 1-10; 10: highest). Results: the features of the pts in Group A vs. Group B are: N: 48 vs. 72; F/M: 26/22 vs. 32/40; age 41(21) vs. 39(13) yrs, high/not high education level: 26/22 vs. 38/34, symptom score mean(SD): 10(6) vs. 12(8) respectively (all NS). Following data were obtained -all expressed as mean(SD), Group A vs. Group B: STAI I: 41.7(8.5)vs.48(11)(p<0.01); STAI II:40.2(9.9)vs.47.1(8.8)(p<0.01); SF36 each scale p<0.05; satisfaction 7.5(4.1)vs. 5.8(3.3)(p<0.01; time offered by MD: 7.0(4.6)vs. 4.0(3.3)(p<0.05); knowledge of pts. on IBS: 6.6(2.6) vs. 4.7(3.2)(p<0.05); adherence: 5.9(3.7)vs. 3.5(2,7)(p<0.02). Conclusions: MDs trained in BPS are able to better care of their IBS pts, and this is reflected in all the parameters investigated: anxiety, QoL, satisfaction, time offered to pts, pts. education and adherence to therapy.
Sa1103 Sa1105 The use of Irrigation Pumps During Colonoscopy Improves the Quality of the Exam and Decreases the Likelihood of Repeating the Procedure at a Short Interval Rana Sabbagh, Sujan Ravi, Lakshminarayanan Nandagopal, Fadi Antaki
Short Interval From Diagnosis to Rescue Infliximab is Associated With Increased Cumulative Risk of Colectomy in Acute Severe Ulcerative Colitis Zaid Heetun, Kavinderjit S. Nanda, Denise Keegan, Kathryn Byrne, Garret Cullen, Diarmuid P. O'Donoghue, Hugh Mulcahy, Glen A. Doherty
Introduction: Colonoscopy is widely used as a screening and diagnostic test. The quality of bowel preparation (prep) affects exam quality, and influences the interval for repeating the procedure. Irrigation pumps that connect to the auxiliary channel of the colonoscope are widely used but their effectiveness has never been studied. Methods: A retrospective chart review study was conducted of all subjects who had an outpatient colonoscopy performed during a 3-month period when the pumps were not in use at our medical center as well as two other 3-month time periods that served as controls. Exclusion criteria included procedures aborted for any reason other than poor prep, inpatient colonoscopy and procedures repeated because of prior poor prep. Data was collected for each case including the use of irrigation pumps, race, gender, indication for colonoscopy, history of polyps or CRC, number and pathology of polyps, prep quality, aborted procedure as well as any recommendations for a repeat procedure at short interval. Chi-square test, two sided t-test, and multivariate logistic regression were used to analyze the data. Results: Information was collected for 1037 colonoscopies. The irrigation pump was used for 709 colonoscopies. Mean age of the group was 60.23 yrs. Majority were male (93.5%). The study group included 535 (51.6%) African-Americans and 487 (47%) Caucasians. 564 colonoscopies were performed for screening (54.4%), while 473 (45.6%) were performed for diagnostic purposes. 272 (26.2%) of these patients had a prior history of polyps/CRC. A significantly higher proportion of cases had a poor or fair prep when pumps were not in use as compared to the controls (24.4% vs. 10.3%, p<0.01). The number of procedures aborted due to poor prep was not significantly different between the two groups, however a repeat procedure at a short interval was recommended in a significantly higher proportion of cases when pumps were not used (21.3% vs. 6.9%, p<0.01). On multivariate logistic regression analysis, after adjusting for indication, history of polyps or CRC, sex, age, and race, the odds of calling a prep good or excellent was 2.91 (95% CI= 2.04-4.15) times more likely when pumps were used in comparison to when pumps were not used. When adjusted to the same variables, the detection of polyps, adenomas, high-risk polyps and right-sided colon polyps was not significantly different between the two groups. Conclusion: The use of the auxiliary channel irrigation pumps during colonoscopy results in a significantly higher proportion of colonic preparation being rated as good or excellent and although polyp detection rate is not significantly affected, possibly due to the heightened vigilance of the endoscopist, the odds of recommending a repeat procedure at a shorter than usual interval is significantly decreased. Table One
Background Infliximab (IFX) is a monoclonal antibody to TNF-alpha which is licensed for treatment of both Crohn's disease and Ulcerative Colitis (UC). IFX is increasingly well established as rescue therapy for patients with acute severe UC where with inadequate response to intravenous hydrocortisone, but reported success is variable. We aimed to assess the success of rescue therapy with IFX and identify factors predictive of the cumulative risk of colectomy. Methods Patients (n=43) who received IFX as rescue therapy for acute severe UC over a 10 year period were identified from a prospectively maintained database of patients with IBD (n=2,700). The cumulative incidence of colectomy during follow-up was calculated and log rank statistics were calculated as a function of patient characteristics using Stata software (Version 11.0) Results 43 patients with severe UC receiving IFX were identified with a median follow up of 21 months (IQR 6-38 months). Median albumin at time of IFX infusion was 24g/dL (IQR 20-29) and median CRP measured 46mg/dL (IQR 28-77). 13/43 (30%) of patients underwent colectomy within 14 days, rising to 25/43 (58%) at 6 months. This compares with a published cumulative incidence of colectomy with Cyclosporine rescue in our centre of 42% at 6 months. 14 patients (33%) avoided colectomy during follow up; 8 patients remain on maintenance IFX, 5 patients are maintained on other therapy (n=3 with Adalimumab, n=2 with azathioprine), one patient is lost of follow up. One patient died from PCP infection following IFX treatment. The cumulative incidence of colectomy was unrelated to smoking status, extent of disease, family history, CRP or albumin at time of rescue. Only the presence of a short interval between diagnosis of UC and use of rescue therapy (<6 months) was associated with a significantly higher risk of colectomy during follow up (log rank, p=0.004); median time to colectomy being 9 days in the short interval to infliximab group compared to 146 days. Conclusion The observed success of IFX as rescue therapy in UC is less than reported in other series and the incidence of colectomy is higher than that previously reported for CyA rescue by our unit. Risk of colectomy during follow up is increased in patients with a short interval (<6months) between diagnosis of UC and requirement for rescue therapy, suggesting that infliximab rescue therapy is best avoided in this patient group due to poor efficacy. Sa1106 Can Serum Pepsinogen I/II Ratio Predict Multiple Lesions of Early Stage Gastric Neoplasias Before Endoscopic Submucosal Dissection? Hyun-Soo Kim, Ki Won Jo, Ho Yoel Ryu, So Yeon Park, Jin Heon Hong, Hong Jun Park, Il Young Lee, Jae Woo Kim Background/Aim: Although the levels of pepsinogen is useful serologic markers for chronic atrophic gastritis, pepsinogen is also related to other factors such as Helicobacter pylori (H. pylori) infection, age and various gastrointestinal diseases. However it remains unclear whether multiple lesions and progression of gastgric neoplasia are associated with serum
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