Common Bile Duct Dilation after Bariatric Surgery

AGA Abstracts

Su2042

Homeostatic Model of Insulin Resistance (HOMA-IR). Results: 16 weeks after DJBS implantation, mean body weight decreased significantly (p<0.001) from a baseline of 126.3 ± 16.1 to 117.3 ±16.3kg. Alanine Transaminase (ALT) serum levels normalised (median 34(25-44) to 24 (15-34) U/L; p=0.02) and change in ALT was correlated with total body weight loss (r=0.80; p<0.001) TE demonstrated a trend toward a significant reduction (p=0.06) in median liver stiffness from a median of 7.75 (5.33 - 21.8) to 4.4 (4.18 - 6.88) kPa. The Controlled Attenuation Parameter (CAP) reduced from a median of 348 (316-391) to 309 (260-370) dB/M (p=0.03). Whilst there was no significant improvement in HOMA-IR, change in HOMA-IR was correlated with total body weight loss (r=0.525; p=0.0471). Conclusion: While it is well established that bariatric endoscopic therapies effectively contribute to the weight loss achieved within a multimodal treatment approach, our data demonstrate that during the treatment course, improvement in HOMA-IR is associated with the degree of weight loss achieved. Additionally, the changes in ALT, TE and CAP measures suggest an improvement in hepatic inflammation, steatosis and fibrosis. Further data are required to explore the long-term outcomes for these patients.

AUGMENTATION OF MEAL-RELATED SYMPTOMS FOLLOWING PLACEMENT OF DUODENAL-JEJUNAL BYPASS SLEEVE IS A POTENTIAL MECHANISM OF ACTION INDUCING WEIGHT LOSS Jessica McMaster, Graeme Rich, Arjun Gandhi, Marguerite Kutyla, Caroline Tallis, Graeme Macdonald, Linda Fletcher, Chachay Veronique, Gerald J. Holtmann Background: Endoscopic bariatric interventions such as the Duodenal-Jejunal Bypass Sleeve (DJBS) are emerging to address the obesity epidemic, but the mechanisms of action of these devices have thus far been poorly investigated. The aim of this study was to elucidate the effects of the DJBS on the response to a standardized nutrient challenge test, gastric emptying kinetics (GEK), gastrointestinal symptoms, circulating micronutrient concentrations, and self-reported energy intake to induce weight loss. Methods: With ethics approval and informed consent, a DJBS was inserted in 15 patients with morbid obesity and type 2 diabetes (F:M, 10:5, aged 20-63 years). At baseline and at 1 month, a standardised nutrient challenge test was performed and gastrointestinal symptoms recorded. At baseline and 2 months, patients completed a 13C octanoic acid breath test to assess GEK (expressed as T1/ 2 minutes). In addition, at baseline, 1 and 4 months, gastrointestinal symptoms were assessed utilising the Structured Assessment of Gastrointestinal Symptoms Instrument. Dietary intake and plasma micronutrient concentrations were monitored monthly and every 4 months respectively. Results: The mean baseline BMI of patients was 43.1 ± 6.6 kg/m2. From a baseline of 125.3 ± 16.1 kg, mean body weight significantly decreased within 4 months to 116.3 ± 16.3 kg, (p<0.001). Energy intake was significantly decreased (p<0.001). Selfreported GI symptoms (abdominal pain, fullness, and retrosternal burning) in response to the standardised nutrient challenge increased significantly (p<0.05). In addition, meal-related symptoms (e.g. fullness, bloating, early satiety) significantly increased (p<0.001). However, there was no change in gastric emptying T1/2 minutes, nor changes in plasma levels of vitamins (A, D, E, and folate) and copper, manganese, selenium or zinc. Vitamin B12 concentration decreased (p<0.001), but remained within the normal clinical reference range. Conclusion: The in-situ presence of the DJBS for 16 weeks resulted in significant weight loss. Circulating micronutrient status did not appear to be impacted. The augmented symptom response to the standardised nutrient challenge appears to be linked to meal-related symptoms that were observed during the study period. These symptoms appeared to trigger a reduction in caloric intake that explains the weight loss.

Su2045 COMMON BILE DUCT DILATION AFTER BARIATRIC SURGERY Neal Mehta, Andrew T. Strong, Tyler Stevens, Adeyinka Owoyele, Ahmed Eltelbany, Prabhleen Chahal, Maged Rizk, Carol A. Burke, Rocio Lopez, Bo Hu, Joesph Veniro, John J. Vargo, Matthew Kroh, Amit Bhatt Introduction: Biliary dilation, even if incidentally noted, suggests distal obstruction and prompts further work up such as endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP). Our institution's clinical experience with EUS and ERCP in the symptomatic post-gastric bypass population has revealed a number of patients with radiographically dilated bile ducts, but endoscopically normal papilla without an obvious cause for obstruction. It is unclear if this finding is phenomenological and unrelated, or an effect of bariatric surgery. Additionally, it is unknown whether the type of bariatric surgery, based on technical conduct or efficacy, alter biliary pathophysiology. Thus, we studied whether a change occurs in biliary diameter following roux-en-Y gastric bypass (RYGB) and longitudinal sleeve gastrectomy (LSG). Methods: This is a single center retrospective study assessing biliary diameter before and after RYGB or LSG based on ultrasound, computed tomography or magnetic resonance imaging. All patients undergoing RYGB or LSG from January 2012 to December 2013 who had imaging studies before and greater than 3 months after surgery were included. Those with choledocholithiasis, obstructive jaundice and those without post-operative imaging were excluded. Common bile duct (CBD) diameter was reread by a staff radiologist at the same location in the common bile duct for pre- and postoperative imaging. Baseline clinical factors of age, gender, body mass index, co-morbid illnesses, alcohol use, narcotic use, and smoking history were additionally collected. Results: There were 220 patients who met inclusion criteria (167 RYGB; 53 LSG). The baseline characteristics are shown [Table 1].The average time from surgery to repeat imaging was 24.3 months. After adjusting for pre-operative factors, subjects who underwent an RYGB had an increase in CBD diameter of 1.4mm (95% CI: 0.10 - 0.18), which was greater than the change following LSG 0.7mm (95% CI: 0.01, 0.13) [Table 2]. Conclusions: Bariatric surgery results in common bile duct dilation, with changes more pronounced after gastric bypass. Biliary dilation occurs whether or not patients undergo a cholecystectomy. Further work is necessary to determine the cause and clinical implications of this phenomenon.

Su2043 OBESITY TREATMENT USING NON ADJUSTABLE INTRAGASTRIC BALLOON: A LARGE BRASILIAN MULTICENTRIC STUDY Ricardo J. Fittipaldi-Fernandez, Cristina F. Diestel, Sergio A. Barrichello, Eduardo N. Usuy, joao A. schemberk, Marcella R. Guedes, Marcia S. Torres, antonio F. teixeira 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 a non adjustable IGB. METHODS: A total of 5874 patients were analyzed. A liquid filled IGB 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, and analysis of variance followed by the Tukey post-test. The level of significance was set at p<0.05. RESULTS: The incidence of complications was 7,32 (n=430), as listed below: 299 (5.09%) early IGB removal, 58 (0.98%) absence of weight loss or weight gain. The incidence of gas production inside the balloon was 0.20% (n=12) and the incidence of leakage was 0.54% (n=32); pregnancy was 0.32% (n=19); gastric perforation was 0.06% (n=4); upper digestive bleeding was 0,05% (n=3); Wernick Korsakoff syndrome due to excessive vomiting was 0.01% (n=1), pancreatitis and esophagus perforation was 0.01% each (n=1). Of the 5444 remaining patients, 4081 (74,9%) were women and 1363 (25,1%) were men. Mean age was 38.38 years. The patients showed a significant weight loss, with a significantly lower final BMI (mean: 30.08±5.06 kg/m2) than the initial BMI (mean: 36.94±5.67 kg/m2) (p<0.0001). Mean BMI reduction was 6.85±3.06 kg/m2 (range: 0.25-29.79). Mean percent total body weight loss (TBWL) was 18.42±7.25% and mean percent excess weight loss (EWL) was 65.66±36.24% (range 3.99-336.14). The weight loss in kilograms was 19.13±8.86. The treatment success rate (%EWL>25) was 93.0%, as follow: overweight was 99.0%, grade I obesity was 95.83%, grade II obesity 93.65% and grade III obesity was 86.09%. Percent EWL was higher in the overweight group (131.54%EWL), followed by obesities grades I (76.67%), II (56.01%) and III (45.45%) sequentially (p<0.0001). Percent EWL was also higher in women (69.71%EWL) than in men (53.39%EWL) (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.

Su2044 IMPROVEMENTS OF LIVER AND GLYCAEMIC PARAMETERS AFTER DUODENAL-JEJUNAL BYPASS SLEEVE (DJBS) INSERTION Graeme Rich, Jessica McMaster, Arjun Gandhi, Chachay Veronique, Linda Fletcher, Caroline Tallis, Graeme Macdonald, Gerald J. Holtmann Background: Endoscopic bariatric therapies are increasingly being utilised to achieve significant weight reduction; however, very little is known about effects on metabolic parameters. This study aimed to characterise in obese diabetic patients the effects of an endoscopic bariatric intervention on metabolic and hepatic indices. Methods: After ethics approval and informed consent, 15 patients with morbid obesity and type 2 diabetes (10 females, 5 males, aged 20-63 years) with a mean BMI of 43.1 ± 6.6 kg/m2 had a Duodenal-Jejunal Bypass Sleeve (DJBS) endoscopically inserted. Liver biochemistry and Transient Elastography (TE) data were obtained at baseline and 16 weeks and 24 weeks after insertion. In. addition, glycaemic parameters including fasting insulin and glucose were measured to derive the

AGA Abstracts

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experienced a reduction in fasting glucose (120 to 86 mg/dL for patient 1 and 108 to 89 mg/dL for patient 6). These decreases in glucose were noted within the first month after IGB placement and were maintained over the duration of the study. For all patients, we observed a decrease in average baseline ALT from 34 U/L ±12.1 to 24.8 U/L ±12.8, P= 0.034. A decrease in average systolic and diastolic blood pressure was also noted, but did not reach statistical significance. Early nausea and vomiting were experienced by 80% with late vomiting in 28%. Dehydration, requiring inpatient admission, was seen in one patient (14%). Conclusion This is the first report of IGB use within the VHA. IGB therapy appear to be safe and effective at reducing weight and metabolic comorbidities in veterans in the context of a comprehensive lifestyle program. Further high quality randomized studies are needed to determine the safety and effectiveness of IGBs in metabolic disease.

Figure 1. Change in Body Mass Index (BMI, kg/m2) over time in patients who have completed at least 6 months of IGB therapy and removal of IGB.

Su2049 EXERCISE-DERIVED MYOKINES ALTER THE FATTY ACID PROFILE OF COLORECTAL CANCER CELLS Priyanka Majety, Mart DelaCruz, Lynn Deng, Sanjib Chowdhury, Hemant K. Roy Objective: Exercise is well-established for not only decreasing cancer risk but improving survival with established cancers. Epidemiological data indicates that about 25% reduction in colorectal cancer (CRC) is attributable to exercise (even after controlling for confounders such as obesity and diabetes). Indeed, a recent study of ~1.5 million adults indicates that exercise decreased the risk of CRC (HR, 0.84; 95% CI, 0.77-0.91)[1]. Indeed, the European guidelines suggest that 10% of all CRCs are attributable to lack of exercise[2]. Randomized controlled trials show exercise decreases rectal cell proliferation. These epidemiological studies suggest an important signal regarding novel biological agents. The objective of the study is to determine the beneficial effect of exercise-derived myokine treatment on the fatty acid profile of CRC cells. Methods: We have developed a novel cell culture platform to harness the effect of exercise on cancer. This system employs conditioned media from a myoblast tubules that contract via electrical stimulation. The release of myokines/cytokines was validated by mouse myokine array (Figure 1). We used a well-established human colon cancer cell line HT-29 cells for the study. HT-29 cells were treated with unstimulated (control) and stimulated (test) conditioned media for 48 hours for free and total fatty acid analysis by using HP 6890/5973 Gas Chromatograph and Mass Spectrometer (GC/MS). Results: We observed striking differences in free and total fatty acid profile between the control and test samples (Figure 2). Importantly, several fatty acids were differentially regulated in the test samples following treatment with exercise-stimulated media. Conclusion: This study is the first to report the effect of exercise-derived myokine treatment using an in vitro exercise model in regulating lipid content of the CRC cells. Future studies will focus on identifying specific myokines that might be involved in the lipid regulation of CRC cells. References: 1. Moore, S.C., et al., Association of Leisure-Time Physical Activity With Risk of 26 Types of Cancer in 1.44 Million Adults. JAMA Intern Med, 2016. 176(6): p. 81625. 2. Leitzmann, M., et al., European Code against Cancer 4th Edition: Physical activity and cancer. Cancer Epidemiol, 2015. 39 Suppl 1: p. S46-55.

Statistics presented as Mean ± SD, Median [P25, P75] or N (column %). p-values: a=ANOVA, b=Kruskal-Wallis test, c=Pearson's chi-square test Table 2. Adjusted Change in CBD Diameter

*Adjusting for age, pre-operative CBD diameter, time since surgery, post-operative imaging, and cholecystectomy in the case of all subjects

Su2046 THE IMPACT OF INTRAGASTRIC BALLOONS ON METABOLIC DISEASE IN VETERANS: RESULTS OF A 6-MONTH PILOT STUDY Violeta Popov, Marianna T. Papademetriou, Kenneth Park, Gail Schechter, Michael Poles More than 78% of veterans are overweight or obese. To address this issue, the Veterans Health Administration (VHA) has implemented a comprehensive lifestyle program (MOVE!). Intragastric balloons (IGBs) offer a minimally-invasive weight loss option that is significantly more effective than lifestyle changes alone, but the procedure to place IGBs is currently not reimbursed. We hypothesized that initiating a program that combines lifestyle modifications with IGB therapy would result in significant weight loss and reduce obesity-associated comorbidities among veterans. Methods: Study type: Retrospective review of prospectivelycollected patients' data Setting: New York VA Harbor Healthcare System(Manhattan) Population: Eligible veteran patients age 18-65 with BMI 30-40 kg/m2 Intervention: IGB therapy (Orbera Intragastric Balloon System, Apollo Endosurgery, Austin, TX) for 6 mo, combined with 12 monthly visits with the MOVE! program Primary outcome:Total body weight loss (TBWL, %) and body mass index (BMI, kg/m2) change from baseline (IGB insertion) to 6 mo (IGB removal), and after 12 mo (end of MOVE! Visits) Secondary outcomes: Reduction in metabolic parameters and resolution/improvement of metabolic disease and patient safety Analysis: Average with standard deviation (SD); t test for significance (P<0.05) Results: By December 2016, 8 patients have undergone successful IGB placement and 4 patients have reached the 6-month time-point and IGB removal. For these patients, the average TBWL was 15.4% ± 6%; BMI decreased from baseline of 36 ±3 kg/m2 to 30 ±3.8 kg/m2; P=0.035 (Figure 1). Two patients (Patients 1 (on metformin) and Patient 6 (on metformin and glargine)) had diabetes at baseline with a HgA1C of 7.5% and 7.3%, respectively. After an average of 5.5 months, their HgA1C levels decreased to 4.7% and 5.5%. Patient 1 was able to stop metformin and patient 6 was able to discontinue insulin. Those same patients

Figure 1: Validation using Myokine array

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AGA Abstracts

AGA Abstracts

Table 1. Demographics and Clinical Characteristics