Endoscopic Sleeve Gastroplasty (ESG) for High-Risk Patients, High Body Mass Index (> 50 kg/m2) Patients, and Contraindication to Abdominal Surgery.

BACKGROUND: For high-risk classified patients, patients with superobesity and in cases of contraindication to abdominal surgery, traditional bariatric surgery might lead to potential morbidity and mortality. Endoscopic sleeve gastroplasty (ESG) is a novel and effective bariatric therapy for morbidly obese patients. Our research group initially evaluated the safety, feasibility, and efficacy of ESG for high-risk, high body mass index (BMI) patients, and patients contraindicated to abdominal surgeries. METHODS: Eligible patients characterized as high-risk for bariatric surgery due to high-BMI, severe comorbidities, or impenetrable abdomen were prospectively documented. ESG was performed by using Overstich® (Apollo Endosurgery, Austin, TX, USA). Primary outcomes included technical success, post-procedure adverse events and mortality, and the change of weight and BMI. RESULTS: ESG was successfully performed for all patients (N = 24, mean age was 55.6 (± 9.2) years old, 75% male). Baseline weight and BMI were 157.9 (± 49.1) kg and 49.9 (± 14.4) kg/m2. According to Edmonton Obesity Staging System (EOSS), 8 (33.3%), 14 (58.3%), and 2 (8.3%) patients were respectively classified as EOSS 2, 3, and 4. Mean operation time was 114.7 (± 26.0) min, without intraoperative complication. Weight loss, BMI reduction, %total weight loss (%TWL), and %excess weight loss (%EWL) were 17.5 (± 14.6) kg, 5.6 (± 4.6) kg/m2, 12.2% (± 8.9%), and 29.1% (± 17.9%) at post-ESG 12-month, respectively. One (4.2%) moderate post-procedure adverse event (gastric mucosal bleeding) was observed. CONCLUSIONS: ESG can be used as a safe, feasible, and effective option for the therapy of patients with superobesity, high-risk patients, and patients contraindicated to abdominal surgery. Graphical Abstract.

Duodenal mucosal resurfacing: Multicenter experience implementing a minimally invasive endoscopic procedure for treatment of type 2 diabetes mellitus.

Background and study aims Duodenal mucosal resurfacing (DMR) is an endoscopic procedure which improves insulin resistant metabolic disease, including type 2 diabetes mellitus (T2DM). The aim of this report was to evaluate the feasibility and procedural aspects of DMR and to provide more specific DMR procedural guidance for endoscopists. Patients and methods In this international multicenter, prospective, open-label study, patients on oral anti-diabetic agents for treating T2DM underwent single DMR. DMR entails circumferential submucosal lifting followed by circumferential mucosal hydrothermal ablation using an over-the-guidewire balloon catheter for lifting and ablation. For the first 28 patients a dual catheter system was used. During the study, a new integrated catheter was developed which was used for the latter 18 patients. During DMR, procedure success (complete DMR: duodenal ablation length ≥ 9 cm) and procedure duration were captured. Results Forty-six patients underwent DMR. Using the dual catheter system, a complete DMR was performed in 22 of 28 patients (79 %). In the next eighteen patients who underwent DMR with the integrated catheter, a complete DMR was performed in 15 of 18 patients (83 %). The integrated catheter facilitated the DMR procedure and resulted in a reduction in procedure time. A detailed table and video are provided for future endoscopists. Conclusions In our multicenter study, DMR was found to be feasible in the hands of experienced endoscopists. The integrated DMR catheter was a welcome modification during the study, allowing for easier ablation administration. Further optimization of the technique would be valuable prior to widespread dissemination.

Technical innovation: Intragastric Single Port Sleeve Gastrectomy (IGSG). A feasibility survival study on porcine model.

PURPOSE: To perform technically the laparoscopic sleeve gastrectomy (LSG) using a unique Intragastric Single Port (IGSG) in animal swine model, evidencing an effective and safe procedure, optimizing the conventional technique. METHODS: IGSG was performed in 4 minipigs, using a percutaneous intragastric single port located in the pre-pyloric region. The gastric stapling of the greater curvature started from the pre-pyloric region towards the angle of His by Endo GIA™ system and the specimen was removed through the single port. In the postoperative day 30, the animals were sacrificed and submitted to autopsy. RESULTS: All procedures were performed without conversion, and all survived 30 days. The mean operative time was 42 min. During the perioperative period no complications were observed during invagination and stapling. No postoperative complications occurred. Post-mortem examination showed no leaks or infectious complications. CONCLUSION: Intragastric Single Port is a feasible procedure that may be a suitable alternative technique of sleeve gastrectomy for the treatment of morbid obesity.

Technical innovation: Intragastric Single Port Sleeve Gastrectomy (IGSG). A feasibility survival study on porcine model

Abstract Purpose: To perform technically the laparoscopic sleeve gastrectomy (LSG) using a unique Intragastric Single Port (IGSG) in animal swine model, evidencing an effective and safe procedure, optimizing the conventional technique. Methods: IGSG was performed in 4 minipigs, using a percutaneous intragastric single port located in the pre-pyloric region. The gastric stapling of the greater curvature started from the pre-pyloric region towards the angle of His by Endo GIA™ system and the specimen was removed through the single port. In the postoperative day 30, the animals were sacrificed and submitted to autopsy. Results: All procedures were performed without conversion, and all survived 30 days. The mean operative time was 42 min. During the perioperative period no complications were observed during invagination and stapling. No postoperative complications occurred. Post-mortem examination showed no leaks or infectious complications. Conclusion: Intragastric Single Port is a feasible procedure that may be a suitable alternative technique of sleeve gastrectomy for the treatment of morbid obesity.

Obesity Treatment with Botulinum Toxin-A Is Not Effective: a Systematic Review and Meta-Analysis.

The effectiveness of gastric injections of botulinum toxin-A (BTA) as primary treatment for obesity is not well known since results in literature are discrepant. Hence, we aimed to systematically review and meta-analyze the available data to assess the real effect of BTA therapy. We searched MEDLINE, Embase, Cochrane, SCOPUS, EBSCO, LILACS, and BVS. We considered eligible only randomized controlled trials enrolling obese patients comparing BTA versus saline injections. Our initial search identified 8811 records. Six studies fulfilled eligibility criteria. After critical appraisal, two articles were excluded and we meta-analyzed the remainder. The mean difference for absolute weight loss and BMI reduction were 0.12 [CI 95%, - 1.14, 1.38] and - 0.06 [95% CI, - 0.92, 0.81], respectively. Therefore, we concluded that treatment of obesity with BTA is not effective.

Endobarrier® in Grade I Obese Patients with Long-Standing Type 2 Diabetes: Role of Gastrointestinal Hormones in Glucose Metabolism.

BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of Endobarrier® in grade 1 obese T2DM patients with poor metabolic control and the role of gastro-intestinal hormone changes on the metabolic outcomes. METHODS: Twenty-one patients aged 54.1 ± 9.5 years, diabetes duration 14.8 ± 8.5 years, BMI 33.4 ± 1.9 kg/m2, and HbA1c 9.1 ± 1.3 %, under insulin therapy, were implanted with Endobarrier®. Fasting concentrations of PYY, ghrelin and glucagon, and AUC for GLP-1 after a standard meal test were determined prior to and at months 1 and 12 after implantation. RESULTS: Patients lost 14.9 ± 5.7 % of their total body weight. HbA1c decreased 1.3 % in the first month, but at the end of the study, the reduction was 0.6 %. HbA1c ≤ 7 % was achieved in 26.3 % of patients. No differences in GLP-1 AUC values were found before and after implant. Fasting plasma ghrelin and PYY concentrations increased from month 1 to 12. Conversely, fasting plasma glucagon concentrations decreased at month 1 and increased thereafter. Weight (ß 0.152) and HbA1c decrease at month 1 (ß 0.176) were the only variables predictive of HbA1c values at 12 months (adjusted R 2 for the model 0.693, p = 0.001). Minor adverse events occurred in 14 % of patients and major events in 9.5 %. CONCLUSIONS: Endobarrier® in T2DM patients with grade I obesity and poor metabolic control is associated with significant weight decrease and moderate reduction in HbA1c at month 12. Our data do not support a role for GLP-1 in the metabolic improvement in this subset of patients.

LONG-TERM POSTOPERATIVE ENDOSCOPIC FINDINGS AFTER GASTRIC BYPASS PROCEDURE: a co-occurrence analysis.

BACKGROUND: A multitude of endoscopic findings post-gastric bypass procedures have been previously reported in the literature, but to our knowledge, no present rules exist that could guide clinicians regarding which findings should be actively sought, once an initial finding is identified. OBJECTIVE: To identify co-occurrence patterns among endoscopic findings of patients having undergone past gastric bypass procedure. METHODS: Our registry involves all consecutive patients undergoing an upper endoscopic evaluation after a gastric bypass procedure. We collected information on the presence of the endoscopic findings in post-gastric bypass surgery patients. Co-occurrence evaluation involved the use of intersection, cluster and item factor analyses. RESULTS: A total of 396 endoscopic evaluations were made on 339 patients. Most patients were female (81.1%), with an average BMI of 31.88±6.7 at the time of endoscopy. Esophagitis was the most common isolated finding (35.3%). Endoscopic findings clustered around two groups, (1) the ring-related complications involving ring displacement, ring slips and gastric pouch, while (2) stenosis-related findings involved dilation and stenosis (P<0.01). CONCLUSION: While most endoscopic findings after gastric bypass endoscopic procedures are isolated, ring and stenosis-related clusters should be used as a set of rules by clinicians, as it might enhance their probability of finding co-occurring conditions.

SAFETY AND EFFECTIVENESS OF SINGLE ANASTOMOSIS DUODENAL SWITCH PROCEDURE: PRELIMINARY RESULT FROM A SINGLE INSTITUTION.

Background: Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) was introduced into bariatric surgery by Sanchez-Pernaute et al. as an advancement of the biliopancreatic diversion with duodenal switch. Aim: To evaluate the SADI-S procedure with regard to weight loss, comorbidity resolution, and complication rate in the super obese population. Methods: A retrospective chart review was performed on initial 72 patients who underwent laparoscopic or robot-assisted laparoscopic SADI-S between December 17th, 2013 and July 29th, 2015. Results: A total of 48 female and 21 male patients were included with a mean age of 42.4±10.0 years (range, 22-67). The mean body mass index (BMI) at the time of procedure was 58.4±8.3 kg/m2 (range, 42.3-91.8). Mean length of hospital stay was 4.3±2.6 days (range, 3-24). Thirty-day readmission rate was 4.3% (n=3), due to tachycardia (n=1), deep venous thrombosis (n=1), and viral gastroenteritis (n=1). Thirty-day reoperation rate was 5.8% (n=4) for perforation of the small bowel (n=1), leakage (n=1), duodenal stump leakage (n=1), and diagnostic laparoscopy (n=1). Percentage of excess weight loss (%EWL) was 28.5±8.8 % (range, 13.3-45.0) at three months (n=28), 41.7±11.1 % (range, 19.6-69.6) at six months (n=50), and 61.6±12.0 % (range, 40.1-91.2) at 12 months (n=23) after the procedure. A total of 18 patients (26.1%) presented with type II diabetes mellitus at the time of surgery. Of these patients, 9 (50.0%) had their diabetes resolved, and six (33.3%) had it improved by 6-12 months after SADI-S. Conclusions: SADI-S is a feasible operation with a promising weight loss and diabetes resolution in the super-obese population.

Racional: Anastomose única em bypass duodenoileal com gastrectomia vertical (SADI-S) foi introduzida na cirurgia bariátrica por Sanchez-Pernaute et al. como um avanço da derivação biliopancreática com switch duodenal. Objetivo: Avaliar o procedimento SADI-S no que diz respeito à perda de peso, resolução de comorbidades e taxa de complicações na população de superobesos. Métodos: Estudo retrospectivo com 72 pacientes iniciais que foram submetidos à laparoscopia ou por robô-assistida SADI-S laparoscópica entre 17 de dezembro de 2013 e 29 de Julho de 2015. Resultados: Foram incluídos 48 pacientes do sexo feminino e 21 do masculino com média idade de 42,4±10,0 anos (variação, 22-67). O índice de massa corporal (IMC) no momento do procedimento foi de 58,4±8,3 kg/m2 (42,3-91,8). O tempo médio de permanência hospitalar foi de 4,3±2,6 dias (3-24). A taxa de readmissão em 30 dias foi de 4,3% (n=3), devido à taquicardia (n=1), trombose venosa profunda (n=1), e gastroenterite viral (n=1). A taxa de reoperação em 30 dias foi de 5,8% (n=4) para a perfuração do intestino delgado (n=1), fístula (n=1), deiscência do coto duodenal (n=1), e laparoscopia de diagnóstico (n=1). Percentagem de excesso de perda de peso (% PEP) foi de 28,5±8,8% (13,3-45,0) em três meses (n=28), 41,7±11,1% (19,6-69,6) em seis meses (n=50), e 61,6±12,0% (40,1-91,2) aos 12 meses (n=23) após o procedimento. Um total de 18 pacientes (26,1%) apresentou-se com diabete melito tipo 2, no momento da operação. Desses, nove (50,0%) tiveram seu diabete resolvido, e seis (33,3%) tinham melhorado em 6-12 meses após SADI-S. Conclusão: SADI-S é operação viável com promissora perda de peso e de resolução do diabete melito na população de superobesos.

SAFETY AND EFFECTIVENESS OF SINGLE ANASTOMOSIS DUODENAL SWITCH PROCEDURE: PRELIMINARY RESULT FROM A SINGLE INSTITUTION / SEGURANÇA E EFICÁCIA DE ANASTOMOSE ÚNICA NO SWITCH DUODENAL: RESULTADO PRELIMINAR DE UMA ÚNICA INSTITUIÇÃO

ABSTRACT Background: Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) was introduced into bariatric surgery by Sanchez-Pernaute et al. as an advancement of the biliopancreatic diversion with duodenal switch. Aim: To evaluate the SADI-S procedure with regard to weight loss, comorbidity resolution, and complication rate in the super obese population. Methods: A retrospective chart review was performed on initial 72 patients who underwent laparoscopic or robot-assisted laparoscopic SADI-S between December 17th, 2013 and July 29th, 2015. Results: A total of 48 female and 21 male patients were included with a mean age of 42.4±10.0 years (range, 22-67). The mean body mass index (BMI) at the time of procedure was 58.4±8.3 kg/m2 (range, 42.3-91.8). Mean length of hospital stay was 4.3±2.6 days (range, 3-24). Thirty-day readmission rate was 4.3% (n=3), due to tachycardia (n=1), deep venous thrombosis (n=1), and viral gastroenteritis (n=1). Thirty-day reoperation rate was 5.8% (n=4) for perforation of the small bowel (n=1), leakage (n=1), duodenal stump leakage (n=1), and diagnostic laparoscopy (n=1). Percentage of excess weight loss (%EWL) was 28.5±8.8 % (range, 13.3-45.0) at three months (n=28), 41.7±11.1 % (range, 19.6-69.6) at six months (n=50), and 61.6±12.0 % (range, 40.1-91.2) at 12 months (n=23) after the procedure. A total of 18 patients (26.1%) presented with type II diabetes mellitus at the time of surgery. Of these patients, 9 (50.0%) had their diabetes resolved, and six (33.3%) had it improved by 6-12 months after SADI-S. Conclusions: SADI-S is a feasible operation with a promising weight loss and diabetes resolution in the super-obese population.

RESUMO Racional: Anastomose única em bypass duodenoileal com gastrectomia vertical (SADI-S) foi introduzida na cirurgia bariátrica por Sanchez-Pernaute et al. como um avanço da derivação biliopancreática com switch duodenal. Objetivo: Avaliar o procedimento SADI-S no que diz respeito à perda de peso, resolução de comorbidades e taxa de complicações na população de superobesos. Métodos: Estudo retrospectivo com 72 pacientes iniciais que foram submetidos à laparoscopia ou por robô-assistida SADI-S laparoscópica entre 17 de dezembro de 2013 e 29 de Julho de 2015. Resultados: Foram incluídos 48 pacientes do sexo feminino e 21 do masculino com média idade de 42,4±10,0 anos (variação, 22-67). O índice de massa corporal (IMC) no momento do procedimento foi de 58,4±8,3 kg/m2 (42,3-91,8). O tempo médio de permanência hospitalar foi de 4,3±2,6 dias (3-24). A taxa de readmissão em 30 dias foi de 4,3% (n=3), devido à taquicardia (n=1), trombose venosa profunda (n=1), e gastroenterite viral (n=1). A taxa de reoperação em 30 dias foi de 5,8% (n=4) para a perfuração do intestino delgado (n=1), fístula (n=1), deiscência do coto duodenal (n=1), e laparoscopia de diagnóstico (n=1). Percentagem de excesso de perda de peso (% PEP) foi de 28,5±8,8% (13,3-45,0) em três meses (n=28), 41,7±11,1% (19,6-69,6) em seis meses (n=50), e 61,6±12,0% (40,1-91,2) aos 12 meses (n=23) após o procedimento. Um total de 18 pacientes (26,1%) apresentou-se com diabete melito tipo 2, no momento da operação. Desses, nove (50,0%) tiveram seu diabete resolvido, e seis (33,3%) tinham melhorado em 6-12 meses após SADI-S. Conclusões: SADI-S é operação viável com promissora perda de peso e de resolução do diabete melito na população de superobesos.

Endoscopic sleeve gastroplasty for the treatment of obesity.

BACKGROUND AND STUDY AIMS: Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy. The objective of this study was to evaluate endoscopic sleeve gastroplasty. PATIENTS AND METHODS: This was a prospective, single-center study of 20 patients who underwent flexible endoscopic suturing for endoluminal gastric volume reduction. A multidisciplinary team provided postprocedure care. Patient status and weight were recorded at baseline, and at 1, 3, and 6 months after the procedure. RESULTS: There were no adverse events and all patients were discharged in less than 24 hours. Baseline mean body mass index was 38.5 kg/m(2), and mean age was 45.8 years. Initial body weight (108.5 ±â€Š14.9 kg) was significantly reduced. Following the procedure, the mean body weight reduction was 8.2 ±â€Š2.5 kg at 1 month (% of initial weight loss 7.6 %; P < 0.05), 13.6 ±â€Š4.8 kg at 3 months (12.4 % weight loss; P < 0.05), and 19.3 ±â€Š8.9 kg at 6 months (17.8 % weight loss; P < 0.05). CONCLUSION: Endoscopic sleeve gastroplasty can be effective for the treatment of patients with obesity.

Initial human experience with restrictive duodenal-jejunal bypass liner for treatment of morbid obesity.

BACKGROUND: The duodenal-jejunal bypass liner is an endoscopically placed and removable intestinal liner that creates a duodenal-jejunal bypass, leading to diabetes improvement and weight loss. The aim of the present study was to evaluate the clinical effects and safety of the duodenal-jejunal bypass liner combined with a restrictor orifice (flow restrictor). METHODS: The device was endoscopically implanted in 10 patients (body mass index 40.8 +/- 4.0 kg/m(2)) and removed after 12 weeks. Dilation of the restrictor orifice was performed as clinically indicated with a 6-, 8-, or 10-mm diameter through-the-scope balloon. The measured outcomes included the percentage of excess weight loss, total weight loss, adverse events, and gastric emptying (GE) at baseline, weeks 4 and 12 of implantation, and 3-5 months after device removal. GE was measured by scintigraphy at 1, 2, and 4 hours after implantation. RESULTS: The percentage of excess weight loss and total weight loss at explantation was 40% +/- 3% (range 21-64%) and 16.7 +/- 1.4 kg (range 12.0-26.0), respectively. The 4-hour GE was 98% +/- 1% at baseline, 72% +/- 6% at 4 weeks (P = 0.001 versus baseline), and 84% +/- 5% at 12 weeks (P <.05 versus baseline). After explantation, the rate of GE returned to normal in 7 of 8 subjects, but remained slightly delayed in 1 subject (84% at 4 hours). Episodes of nausea, vomiting, and abdominal pain required endoscopic dilation of the restrictor orifice with a 6-mm through-the-scope balloon in 7 patients and a 10-mm balloon in 1, with no clinically significant adverse events. CONCLUSION: Endoscopic implantation of a combination flow restrictor and duodenal-jejunal bypass liner induced substantial weight loss. The implanted patients exhibited delayed GE that was reversed after device removal.

Pilot clinical study of an endoscopic, removable duodenal-jejunal bypass liner for the treatment of type 2 diabetes.

BACKGROUND: Bariatric surgery is associated with the rapid improvement of type 2 diabetes (T2DM). Here we report an exploratory trial of a completely endoscopic, removable, duodenal-jejunal bypass liner (DJBL) intended to treat T2DM. METHODS: Obese T2DM subjects were randomized to receive a DJBL (n = 12) or sham endoscopy (n = 6) in a 24-week study, extended up to 52 weeks. Measurements included weights, hemoglobin A1c (HbA(1c)), meal tolerance testing, fasting glucose, and seven-point glucose profiles. Subjects' diets were adjusted in the first 2 weeks to obtain similar weight loss during this period. RESULTS: Subjects had baseline HbA(1c) of 9.1 +/- 1.7% and body mass index of 38.9 +/- 6.1 kg/m(2) (+/- SD). In the completer population by week 1, change in fasting glucose in the DJBL arm was -55 +/- 21 mg/dL versus +42 +/- 30 mg/dL in the sham arm (P < or = 0.05; +/- SE); the seven-point glucose profiles were reduced in the DJBL arm but not in the sham arm. Mean postprandial glucose area under the curve was reduced in the DJBL arm by 20% and increased 17% in the sham arm (P = 0.016). At week 12, HbA(1c) change was -1.3 +/- 0.9% in the DJBL arm and -0.7 +/- 0.4% in the sham arm (P > 0.05), and at 24 weeks, values were -2.4 +/- 0.7% in the DJBL arm and -0.8 +/- 0.4% in the sham arm (P > 0.05). Device migrations required endoscopic removal prior to reaching 52 weeks. CONCLUSIONS: The DJBL rapidly normalized glycemic control in obese T2DM subjects, a promising development in the search for novel therapies less invasive than bariatric surgery.