Publications by authors named "Manoel P Galvao-Neto"

Aims: Duodenal mucosal resurfacing (DMR) is an endoscopic procedure developed to improve metabolic parameters and restore insulin sensitivity in patients with diabetes. Here we report long-term DMR safety and efficacy from the REVITA-1 study.

Materials And Methods: REVITA-1 was a prospective, single-arm, open-label, multicenter study of DMR feasibility, safety, and efficacy in patients with type 2 diabetes (hemoglobin A1c [HbA1c] of 7.

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Unlabelled: Insulin resistance is a core pathophysiological defect underscoring type 2 diabetes mellitus (T2DM) and non-alcoholic fatty liver disease (NAFLD). Both conditions improve with duodenal exclusion surgery. Duodenal mucosal resurfacing (DMR) is an endoscopic intervention developed to treat metabolic disease which has been shown to improve glycaemia in patients with poorly controlled T2DM.

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Background And Aims: We aimed to develop duodenal mucosal resurfacing (DMR), a minimally invasive upper endoscopic hydrothermal ablation procedure, to treat insulin-resistant metabolic diseases.

Methods: We completed a sham-controlled, rodent proof-of-concept study and longitudinal safety study in pigs to demonstrate feasibility to test DMR in humans. Subsequently, the DMR procedure was implemented in an open-label first-in-human (FIH) study of safety and efficacy in patients with type 2 diabetes (T2D).

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Background: Endoscopic sutured gastroplasty (ESG) has evolved over time. With the advent of full-thickness endoscopic suturing, an efficient technique for ESG was developed and refined.

Methods: This prospective first-in-man trial started in April 2012 and represents the first use of full-thickness endoscopic suturing for primary obesity therapy.

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Background: Several studies conducted in adults suggest that intragastric balloon (IGB) is an effective and safe method for weight loss. Although the prevalence of obesity in adolescents has increased in recent years, the outcomes of IGB treatment in this age group are not known. The aim of this study was to evaluate the safety and efficacy of IGB treatment for weight loss in adolescents followed up for 6 months.

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Background: The Orbera intragastric balloon (IGB) has been approved by the US Food and Drug Administration for use in patients with a body mass index (BMI) between 30 and 40 kg/m and is in wide use worldwide as a primary and bridge obesity management tool. The balloon filling volume (BFV) ranges between 400 and 700 mL of saline. Our objective was to determine whether there is an association between BFV and clinically relevant endpoints, namely weight loss outcomes, balloon tolerability, and adverse events.

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Background: Roux-en-Y gastric bypass (RYGB) is a standard therapy in bariatric surgery. Sleeve gastrectomy and gastric banding, although with good results in the literature, are showing higher rates of treatment failure to reduce obesity-associated morbidity and body weight. Other problems after bariatric may occur, as band erosion, gastroesophageal reflux disease and might be refractory to medication.

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Objective: To assess procedural safety and glycemic indices at 6 months in a first-in-human study of duodenal mucosal resurfacing (DMR), a novel, minimally invasive, upper endoscopic procedure involving hydrothermal ablation of the duodenal mucosa, in patients with type 2 diabetes and HbA ≥7.5% (58 mmol/mol) on one or more oral antidiabetic agents.

Research Design And Methods: Using novel balloon catheters, DMR was conducted on varying lengths of duodenum in anesthetized patients at a single medical center.

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Background: Applications for natural orifice translumenal endoscopic surgery (NOTES) to access the abdominal cavity have increased in recent years. Despite potential advantages of transanal and transcolonic NOTES for colorectal pathology, it has not been widely applied in the clinical setting. This study describes a series of nine patients for whom we performed transanal retrograde ("Down-to-Up") total mesorectal excision for rectal cancer.

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Background: Among the possible complications of bariatric surgery, fistula and partial dehiscence of the gastric suture are well known. Reoperation often is required but results in significant morbidity. Endoscopic treatment of some bariatric complications is feasible and efficient.

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Background: The purpose of this study was to evaluate the effect of the duodenal-jejunal bypass liner (DJBL), a 60-cm, impermeable fluoropolymer liner anchored in the duodenum to create a duodenal-jejunal bypass, on metabolic parameters in obese subjects with type 2 diabetes.

Methods: Twenty-two subjects (mean age, 46.2±10.

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The erosion of a laparoscopic adjustable gastric band (LAGB) can cause pain that is not controlled by analgesics. In such cases, early endoscopic removal may be indicated, but only when gastric penetration is greater than 50%. We report the case of a patient with severe shoulder pain due to a small area of LAGB erosion, which was treated with early endoscopic removal through an incision in the gastric wall.

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Objectives: Natural orifice translumenal endoscopic surgery (NOTES) is evolving as a promising alternative for abdominal surgery. IMTN Registry was designed to prospectively document early results of natural orifice surgery among a large group of clinical cases.

Methods: Sixteen centers from 9 countries were approved to participate in the study, based on study protocol requirements and local institutional review board approval.

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Background: Silastic rings are used in gastric bypass procedures for the treatment of obesity, but ring slippage may lead to gastric pouch outlet stenosis (GPOS). Conventional management has been ring removal through abdominal surgery.

Objective: To describe a novel, safe, minimally invasive, endoscopic technique for the treatment of GPOS caused by ring slippage after gastric bypass.

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Background: The advent of endoscopic surgery has radically changed surgery worldwide.The concept of minimally invasive procedures has spread quickly, allowing less pain and more rapid recovery for patients. The authors have developed a device for a new surgical approach, the so-called single trocar access (SITRACC).

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We describe the case of early band migration that developed into intraabdominal infection treated by natural orifice translumenal endoscopic surgery. A 40-year-old man was seen 4 years after gastric band placement. He complained of epigastric pain and fever.

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Background: No long-term, international, multicenter studies of the effectiveness and safety of the SAGB in morbid obesity have been previously published. The objective of this study was to assess the effectiveness and safety of the Swedish Adjustable Gastric Band (SAGB) at 6 bariatric centers in Australia, Europe, and Brazil, with < or =5 years of follow-up; the effect on patient covariates; and changes in co-morbidity.

Methods: A 2-phase study design was used, involving both retrospective and prospective data.

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Background: The association between medical and dietetic-behavioral treatments of type 2 diabetes mellitus (T2DM) has demonstrated to have variable results. The surgical treatment of T2DM is justifiable after the observation of a successful glycemic control in patients submitted to Roux-en-Y gastric bypass and biliopancreatic diversion. Experiments have shown an important role of the proximal intestine in glycemia decrease and diabetes control.

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Background: We report the first human experience with an endoscopic duodenal-jejunal bypass sleeve (DJBS) in a community hospital.

Methods: The DJBS is a 60-cm sleeve anchored in the duodenum to create a duodenal-jejunal bypass. In a 12-patient prospective, open-label, single-center, 12-week study, the device was endoscopically implanted, left in situ, and retrieved.

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The staplerless Roux-en-Y gastric bypass (RYGBP) is a new option in bariatric surgery. The first to describe it was Himpens (2004) utilizing the LigaSure Atlas (LSA) in a series of 10 patients. The laparoscopic RYGBP is performed utilizing the LSA for the gastric and jejunal partition; after that, an imbricating running suture is performed to ensure stomach and bowel hermetic closure.

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