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550 Long-Term Effect of Intragastric Balloon in the Management of Obesity
Abstracts
Science through Nov 1, 2016. Published randomized controlled trials (RCTs) and cohort studies that assessed outcomes of DJBL in obese T2DM patients. Authors were contacted if additional data was needed. Data were pooled using a fixed-effects model or random-effects for high heterogeneity. Main Outcomes: Change in hemoglobin A1c (HbA1c) at DJBL explant. Secondary outcomes were change in weight and gut hormones (GIP, GLP-1, PYY, ghrelin) at explant and change in HbA1c 6 month post-explant. Outcomes were reported using difference in means and Hedge’s g. P-value <0.05 was significant. Results: Of 593 potential eligible studies, 18 were included. 7 studies provided additional data. Primary Outcome: 14 of the 18 studies (nZ431) reported the effect of DJBL on glycemic control in obese T2DM patients. Mean baseline characteristics were: age 36-54 years, BMI 30.0-48.9 kg/m2, and HbA1c 6.7%-9.2%, with 75%-100% on metformin, and 0%-63% on insulin. Average duration of implant was 8.44.0 months, with HbA1c decrease of 1.30.2% (p<0.0001) (I2Z61) at removal (Figure 1). Subgroup analysis of RCTs in this population included 5 RCTs (nZ124: 70 DJBL; 54 control (lifestyle modification +/- sham)). DJBL had greater decrease in HbA1c by 0.90.2% (p<0.0001) (I2Z0) at 4.21.6 months. Secondary Outcomes: In studies including T2DM patients with obesity, 4 (nZ188) reported HbA1c post-explant. In the 2 with 6 month data, HbA1c remained lower than baseline by 1.00.1% (p<0.0001). 10 studies (nZ395) reported weight loss and 6 (nZ105) reported hormone data. At 9.23.1 months, patients lost 12.61.3 kg (p<0.0001) (I2Z79), BMI decreased by 4.20.7 kg/m2 (p<0.0001) (I2Z96), %TBWL was 14.26.2% and % EWL was 43.126.9%. GIP significantly decreased at 7.84.3 months. GLP-1, PYY and ghrelin did not change (Table 1). Meta-regression: Initial HbA1c was a significant negative predictor for HbA1c improvement (bZ-0.79, pZ0.002). BMI and duration of implant were not predictors. Conclusion: DJBL improves glycemic control in T2DM patients with obesity with the treatment effect persisting at least 6 months after removal. DJBL also appears to induce significant weight loss in this population. In addition, GIP decreases after DJBL suggesting a robust foregut mechanism.
Table 1. Changes in hemoglobin A1c, weight, BMI and gut hormones after DJBL implantation Primary Outcome Change in HbA1c (%) Secondary Outcomes Change in weight (kg) Change in BMI (kg/m2) Change in GIP (Hedge’s g) Change in GLP-1 (Hedge’s g) Change in PYY (Hedge’s g) Change in ghrelin (Hedge’s g)
IGB has gained popularity recently, however, there is a lack of studies addressing the use of IGB and its effect on weight control in the long-term. This is the first study that aimed to assess the weight regain in a large cohort of patients treated with IGB, with a time span from two to five years after the removal of the device. Methods: All obese patients treated with IGB in a specialized obesity center, and that underwent balloon removal from June 2009 to June 2013 were invited to participate in the study. Exclusion criteria: pregnancy or bariatric surgery after balloon removal, impossibility to contact, and refusal to participate. Patients that agreed to participate were interviewed by a trained investigator in person and answered a questionnaire survey and had their body weight measured. Interviews started on July 2015 and ended on July 2016. Medical records of recruited patients were reviewed and the body weight at the moment of IGB introduction and removal registered. Patients were stratified by segment timeframe from balloon removal and interview date (2,3,4 and 5 years) and all intervening factors related to weight control, as well as behavior habits were analyzed and compared with logistic multivariate analysis. Results: 224 patients were enrolled in the research (182 females, 81.3%). Weight regain after balloon removal was observed in 148 patients (66%). Mean weight regain following balloon removal was 4,664,91kg after 2 years, 8,666,96kg after 3 years, 9,998,44kg after 4 years and 19,9612,24kg after 5 years. The following variables did not affect weight regain: “initial weight” at beginning of treatment and “final weight” at the end of treatment, “weight loss” during treatment. Multivariate logistic analysis demonstrated that the following features were significantly associated with weight regain: lack of psychological support during or after treatment (ODDS: 1,13; pZ0,02; IC95%: 0,55-1,89); lack of nutrition counseling (ODDS: 3,36; p<0,01; IC95%: 1,42-7,94), and sedentary lifestyle (ODDS: 3,86; pZ0,03; IC95%: 1, 13-12,67). Conclusion: IGB has a suboptimal long-term effect on body weight control after 2 to 5 years of balloon removal, with weight regain observed in up to two thirds of patients (66%). The following variables adversely affect long-term body weight control after IGB removal: lack of psychological support and nutrition counseling and sedentary lifestyle. A multidisciplinary team approach is of paramount importance to assist obese patients treated with IGB in order to effectively maintain long-term body weight control.
Changes from Baseline Levels
p-value
I2
Percentage of weight regained in relation to weight loss during treatment
-1.31 [-1.64,-0.98]
<0.0001
61
% of weight regained*
-12.64 [-15.17,-10.10] -4.21 [-5.52,-2.91] -0.36 [-0.57,-0.15] 0.33 [-0.09,0.75] 0.56 [-0.32,1.44] 0.68 [-0.18,1.54]
<0.0001 <0.0001 0.001 0.125 0.215 0.121
79 96 26 77 80 86
<10% Between Between Between Between Between Between
10 20 30 40 50 90
and and and and and and
19% 29% 39% 49% 59% 99%
2 years
3 years
4 years
5 years
20 (2) 70 (7) 10 (1) 0 0 0 0
15,6 (13) 62,7 (52) 14,5 (12) 2,4 (2) 1,2 (1) 2,4 (2) 1,23 (1)
18,5 (10) 59,3 (32) 14,8 (8) 1,9 (1) 5,6 (3) 0 0
33,3 (1) 66,7 (2) 0 0 0 0 0
*Percentage of weight regained Z (Difference between weight at the beginning of treatment and weight at final of treatment, *100)/ weight regain.
Analysis of weight evolution along the time segment Weight Regain
Figure 1. Meta-analysis of changes in HbA1c after DJBL implantation. Mean HbA1c decreased by 1.30.2% (p2 Z 61).
550 Long-Term Effect of Intragastric Balloon in the Management of Obesity Bruno Sander*1, Vitor N. Arantes2, Luiz Alberti2, Manoel Galvao Neto3, Eduardo Grecco4, Thiago F. Souza4 1 Bariatric Endoscopy, Sander Medical Center, Belo Horizonte, Minas Gerais, Brazil; 2Alfa Institute - Endoscopy and Gastroenterology, UFMG, Belo Horizonte, Minas Gerais, Brazil; 3Bariatric Endoscopy, Gastro Obeso Center, São Paulo, São Paulo, Brazil; 4Endoscopy - Surgery, Hospital Mário Covas, São Paulo, São Paulo, Brazil Introduction and Aims: Obesity is a global disease and its management includes pharmacological therapy, nonabsorptive surgery and, Intragastric Balloon (IGB). Any form of therapy, including surgery, is flawed by weight regain in the long-term.
www.giejournal.org
Weight Loss
Time Segment
n
Medium
dp
n
Medium
dp
2 3 4 5
10 83 54 3
4,66 8,66 9,99 19,96
4,91 6,96 8,44 12,24
18 31 23 2
4,46 4,25 4,64 4,01
5,33 5,13 5,65 2,75
years years years years*
Test ANOVA: Weight regain : pZ0,15; Weight loss : pZ0,98 *Excluded group in the analysis (n insufficient) It has been analysed the relation between weight regain and the weight loss during treatment. It was observed among patients who presented weight regain (150) , that a great part of individuals (62%) regained between 10% and 19% of lost weight during treatment .
551 Septotomy to Treatment of Late and Chronic Fistula After Sleeve Gastrectomy and Duodenal Switch: A Novel Endoscopic Approach Josemberg M. Campos*1, Flávio C. Ferreira1, Manoel Galvao Neto2, Lyz B. Silva1, Helga C. Alhinho1, Eduardo S. Godoy1, Delgis A. Martinez1, Milton I. Tube1, Fernanda B. Andrade1, Joana C. Silva1, Maira D. Souza1
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB83
Science through Nov 1, 2016. Published randomized controlled trials (RCTs) and cohort studies that assessed outcomes of DJBL in obese T2DM patients. Authors were contacted if additional data was needed. Data were pooled using a fixed-effects model or random-effects for high heterogeneity. Main Outcomes: Change in hemoglobin A1c (HbA1c) at DJBL explant. Secondary outcomes were change in weight and gut hormones (GIP, GLP-1, PYY, ghrelin) at explant and change in HbA1c 6 month post-explant. Outcomes were reported using difference in means and Hedge’s g. P-value <0.05 was significant. Results: Of 593 potential eligible studies, 18 were included. 7 studies provided additional data. Primary Outcome: 14 of the 18 studies (nZ431) reported the effect of DJBL on glycemic control in obese T2DM patients. Mean baseline characteristics were: age 36-54 years, BMI 30.0-48.9 kg/m2, and HbA1c 6.7%-9.2%, with 75%-100% on metformin, and 0%-63% on insulin. Average duration of implant was 8.44.0 months, with HbA1c decrease of 1.30.2% (p<0.0001) (I2Z61) at removal (Figure 1). Subgroup analysis of RCTs in this population included 5 RCTs (nZ124: 70 DJBL; 54 control (lifestyle modification +/- sham)). DJBL had greater decrease in HbA1c by 0.90.2% (p<0.0001) (I2Z0) at 4.21.6 months. Secondary Outcomes: In studies including T2DM patients with obesity, 4 (nZ188) reported HbA1c post-explant. In the 2 with 6 month data, HbA1c remained lower than baseline by 1.00.1% (p<0.0001). 10 studies (nZ395) reported weight loss and 6 (nZ105) reported hormone data. At 9.23.1 months, patients lost 12.61.3 kg (p<0.0001) (I2Z79), BMI decreased by 4.20.7 kg/m2 (p<0.0001) (I2Z96), %TBWL was 14.26.2% and % EWL was 43.126.9%. GIP significantly decreased at 7.84.3 months. GLP-1, PYY and ghrelin did not change (Table 1). Meta-regression: Initial HbA1c was a significant negative predictor for HbA1c improvement (bZ-0.79, pZ0.002). BMI and duration of implant were not predictors. Conclusion: DJBL improves glycemic control in T2DM patients with obesity with the treatment effect persisting at least 6 months after removal. DJBL also appears to induce significant weight loss in this population. In addition, GIP decreases after DJBL suggesting a robust foregut mechanism.
Table 1. Changes in hemoglobin A1c, weight, BMI and gut hormones after DJBL implantation Primary Outcome Change in HbA1c (%) Secondary Outcomes Change in weight (kg) Change in BMI (kg/m2) Change in GIP (Hedge’s g) Change in GLP-1 (Hedge’s g) Change in PYY (Hedge’s g) Change in ghrelin (Hedge’s g)
IGB has gained popularity recently, however, there is a lack of studies addressing the use of IGB and its effect on weight control in the long-term. This is the first study that aimed to assess the weight regain in a large cohort of patients treated with IGB, with a time span from two to five years after the removal of the device. Methods: All obese patients treated with IGB in a specialized obesity center, and that underwent balloon removal from June 2009 to June 2013 were invited to participate in the study. Exclusion criteria: pregnancy or bariatric surgery after balloon removal, impossibility to contact, and refusal to participate. Patients that agreed to participate were interviewed by a trained investigator in person and answered a questionnaire survey and had their body weight measured. Interviews started on July 2015 and ended on July 2016. Medical records of recruited patients were reviewed and the body weight at the moment of IGB introduction and removal registered. Patients were stratified by segment timeframe from balloon removal and interview date (2,3,4 and 5 years) and all intervening factors related to weight control, as well as behavior habits were analyzed and compared with logistic multivariate analysis. Results: 224 patients were enrolled in the research (182 females, 81.3%). Weight regain after balloon removal was observed in 148 patients (66%). Mean weight regain following balloon removal was 4,664,91kg after 2 years, 8,666,96kg after 3 years, 9,998,44kg after 4 years and 19,9612,24kg after 5 years. The following variables did not affect weight regain: “initial weight” at beginning of treatment and “final weight” at the end of treatment, “weight loss” during treatment. Multivariate logistic analysis demonstrated that the following features were significantly associated with weight regain: lack of psychological support during or after treatment (ODDS: 1,13; pZ0,02; IC95%: 0,55-1,89); lack of nutrition counseling (ODDS: 3,36; p<0,01; IC95%: 1,42-7,94), and sedentary lifestyle (ODDS: 3,86; pZ0,03; IC95%: 1, 13-12,67). Conclusion: IGB has a suboptimal long-term effect on body weight control after 2 to 5 years of balloon removal, with weight regain observed in up to two thirds of patients (66%). The following variables adversely affect long-term body weight control after IGB removal: lack of psychological support and nutrition counseling and sedentary lifestyle. A multidisciplinary team approach is of paramount importance to assist obese patients treated with IGB in order to effectively maintain long-term body weight control.
Changes from Baseline Levels
p-value
I2
Percentage of weight regained in relation to weight loss during treatment
-1.31 [-1.64,-0.98]
<0.0001
61
% of weight regained*
-12.64 [-15.17,-10.10] -4.21 [-5.52,-2.91] -0.36 [-0.57,-0.15] 0.33 [-0.09,0.75] 0.56 [-0.32,1.44] 0.68 [-0.18,1.54]
<0.0001 <0.0001 0.001 0.125 0.215 0.121
79 96 26 77 80 86
<10% Between Between Between Between Between Between
10 20 30 40 50 90
and and and and and and
19% 29% 39% 49% 59% 99%
2 years
3 years
4 years
5 years
20 (2) 70 (7) 10 (1) 0 0 0 0
15,6 (13) 62,7 (52) 14,5 (12) 2,4 (2) 1,2 (1) 2,4 (2) 1,23 (1)
18,5 (10) 59,3 (32) 14,8 (8) 1,9 (1) 5,6 (3) 0 0
33,3 (1) 66,7 (2) 0 0 0 0 0
*Percentage of weight regained Z (Difference between weight at the beginning of treatment and weight at final of treatment, *100)/ weight regain.
Analysis of weight evolution along the time segment Weight Regain
Figure 1. Meta-analysis of changes in HbA1c after DJBL implantation. Mean HbA1c decreased by 1.30.2% (p2 Z 61).
550 Long-Term Effect of Intragastric Balloon in the Management of Obesity Bruno Sander*1, Vitor N. Arantes2, Luiz Alberti2, Manoel Galvao Neto3, Eduardo Grecco4, Thiago F. Souza4 1 Bariatric Endoscopy, Sander Medical Center, Belo Horizonte, Minas Gerais, Brazil; 2Alfa Institute - Endoscopy and Gastroenterology, UFMG, Belo Horizonte, Minas Gerais, Brazil; 3Bariatric Endoscopy, Gastro Obeso Center, São Paulo, São Paulo, Brazil; 4Endoscopy - Surgery, Hospital Mário Covas, São Paulo, São Paulo, Brazil Introduction and Aims: Obesity is a global disease and its management includes pharmacological therapy, nonabsorptive surgery and, Intragastric Balloon (IGB). Any form of therapy, including surgery, is flawed by weight regain in the long-term.
www.giejournal.org
Weight Loss
Time Segment
n
Medium
dp
n
Medium
dp
2 3 4 5
10 83 54 3
4,66 8,66 9,99 19,96
4,91 6,96 8,44 12,24
18 31 23 2
4,46 4,25 4,64 4,01
5,33 5,13 5,65 2,75
years years years years*
Test ANOVA: Weight regain : pZ0,15; Weight loss : pZ0,98 *Excluded group in the analysis (n insufficient) It has been analysed the relation between weight regain and the weight loss during treatment. It was observed among patients who presented weight regain (150) , that a great part of individuals (62%) regained between 10% and 19% of lost weight during treatment .
551 Septotomy to Treatment of Late and Chronic Fistula After Sleeve Gastrectomy and Duodenal Switch: A Novel Endoscopic Approach Josemberg M. Campos*1, Flávio C. Ferreira1, Manoel Galvao Neto2, Lyz B. Silva1, Helga C. Alhinho1, Eduardo S. Godoy1, Delgis A. Martinez1, Milton I. Tube1, Fernanda B. Andrade1, Joana C. Silva1, Maira D. Souza1
Volume 85, No. 5S : 2017 GASTROINTESTINAL ENDOSCOPY AB83