Publications (80) View all
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Article: Endoscopic gastrostomy replacement tubes: Long-term randomized trial with five silicone commercial models.
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ABSTRACT: TRIAL DESIGN: No analysis of the long-term performance of percutaneous endoscopic gastrostomy (PEG) replacement tubes was identified. A randomized partially blinded trial was designed hypothesizing that clinically relevant limitations of the tubes would be identified. METHODS: Patients (N = 100, age 58.3 ± 20.7 years, 42.0% males, time with PEG 27.0 ± 22.5 months) were randomized in five parallel intervention groups, each with a tested device (Silmag(®), Bard(®), Freka(®), Kangaroo(®) and Wilson Cook(®)). Eligibility criteria included age 18-90 years, males and females, on home enteral nutrition, and the setting was a large academic hospital. Patients were allocated according to a random numbers list, and independent professionals were responsible for data collection. Primary outcome was tube longevity, calculated by Kaplan-Meier curves and Cox regression analysis. A sample of 18 was calculated based on a 10% effect size and 80% power. RESULTS: Twenty patients were randomized in each group and all were analyzed. There was no morbidity and mortality, however tube dysfunction was common with all models. Fastener sliding occurred in 57.0% and balloon rupture in 32.0%, along with other mishaps. Best tube longevity corresponded to the Wilson Cook model (158.0 ± 10.0 days, P < 0.05), mostly on account of diminished balloon ruptures. CONCLUSIONS: PEG replacement was safe however relatively frequent and affecting longevity, therefore longer-lasting tubes are needed. Specific attention should be given to cap, feeding line, external clamp, tube fastener; tube length, and notably balloon performance, which may be disappointing. Trial NCT01698827, CNPq Investigator Grant 302915/2011-7.Clinical nutrition (Edinburgh, Scotland) 04/2013; · 3.27 Impact Factor -
Article: Endoscopic ultrasound-guided choledochoduodenostomy and duodenal stenting in patients with unresectable periampullary cancer: one-step procedure by using linear echoendoscope.
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ABSTRACT: Abstract Objective. Describe a case series of endoscopic ultrasound (EUS)-guided choledochoduodenostomy (EUS-CD) associated with duodenal self-expandable metal stents (SEMS) placement using solely the linear echoendoscope in seven patients with obstructive jaundice and duodenal obstruction due to unresectable periampullary cancer. Material and methods. EUS-CD in the first portion of the duodenum, associated with duodenal SEMS placement was performed in seven patients with unresectable periampullary cancer with obstructive jaundice and invasive duodenal obstruction. Laboratory tests and clinical follow-up were performed until patient's death. The procedure was performed by an experienced endoscopist under conscious sedation. The puncture position was chosen based on EUS evaluation, at the common bile duct (CBD) above the tumor, through the distal part of the duodenal bulb. After that, the needle was withdrawn and a wire-guided needle knife was used to enlarge the site puncture in the duodenal wall. Then, a partially covered SEMS was passed over the guide, through the choledochoduodenal fistula. Duodenal SEMS placement was performed during the same endoscopic procedure. Results. The procedure was performed in seven patients, ranging between 34 and 86 years. Technical success of EUS-CD, by the stent placement, occurred in 100% of the cases. There were no early complications. Duodenal SEMS placement was effective in 100% of the cases that remained alive after a follow-up of 7 and 30 days. Conclusion. The results suggest therapeutic EUS one-step procedure drainage as an alternative for these patients, with good clinical success, feasible technique and safety.Scandinavian journal of gastroenterology 01/2013; · 2.08 Impact Factor -
Article: A Pilot Study of the Duodenal-Jejunal Bypass Liner in Low Body Mass Index Type 2 Diabetes.
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ABSTRACT: Context:The duodenal-jejunal bypass liner (DJBL) is a device that mimics the intestinal portion of gastric bypass surgery and has been shown to improve glucose metabolism rapidly in obese subjects with type 2 diabetes (T2DM).Objective:To assess the safety of the DJBL and to evaluate its potential to affect glycemic control beneficially in subjects with T2DM who were not morbidly obese.Patients and Design:Adult men and women with T2DM of ≤10 years' duration with hemoglobin A1c (HbA1c) ≥7.5% and ≤10% and having a body mass index ≥26 to ≤50 kg/m(2) were enrolled in this prospective, 52-week, single-center, open-label clinical study.Main Outcome Measures:Adverse events and changes in body weight, fasting plasma glucose (FPG) levels, and HbA1c levels.Results:Sixteen of 20 subjects implanted with the DJBL completed the 1-year study (mean body mass index = 30.0 ± 3.6, mean ± SD). Gastrointestinal disorders were reported by 13 subjects, and metabolic or nutritional disorders occurred in 14 subjects. FPG levels dropped from 207 ± 61 mg/dL at baseline to 139 ± 37 mg/dL at 1 week and remained low throughout the study. Mean body weight also declined, but the change in body weight was not significantly associated with change in FPG at 52 weeks. HbA1c declined from 8.7 ± 0.9% at baseline to 7.5 ± 1.6% at week 52.Conclusions:The improvements in glycemic status were observed at 1 year in moderately obese subjects with T2DM, suggesting that the DJBL may represent an effective adjuvant to standard medical therapy of T2DM in this population.The Journal of clinical endocrinology and metabolism 01/2013; · 6.50 Impact Factor -
Article: Extrahepatic anterograde covered self-expandable metallic stent placement across malignant biliary obstruction passed by endoscopic ultrasound guidance access: a challenging technique.
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ABSTRACT: The authors report the case of a female patient submitted to endoscopic cholangiography intending to drain the biliary tree due to jaundice. The patient had gastrointestinal deviation due to an advanced gastric cancer that evolved with a distal extrahepatic mass. Abdominal CT scan demonstrated a distal mass, extrahepatic biliary dilation and a normal intra-hepatic tree. In this condition and after a multidisciplinary discussion, an endoscopic ultrasound guided extrahepatic access with the deployment of a partially covered self-expandable metallic stent was performed. The patient normalized her bilirubin levels after a successful procedure.Acta gastroenterologica Latinoamericana 09/2012; 42(3):224-9. -
Conference Proceeding: Endoscopic Papillary Large Balloon Dilation Associated With Sphincterotomy for Extraction of Large Bile Duct Stones
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ABSTRACT: Common bile duct stones larger than 15mm are related to a higher rate of failure of endoscopic ductal clearance and need for mechanical lithotripsy. Recently, endoscopic papillary large balloon dilation (EPLBD) associated with endoscopic sphyncterotomy (ES) has been advocated for the management of difficult bile duct stones. Objective Evaluate the efficacy and safety of EPLBD associated with ES for removal of large bile duct stones. Patients and methods retrospective review of prospectively collected data in an academic tertiary referral center, from November 2009 to August 2011. Ampullary dilation was performed with a wire guided hydrostatic balloon (CRE/Boston Scientific) which size ranged from 12 to 20mm. The stone size and the duct diameter directed the choice of the balloon diameter. Balloon was inflated with diluted contrast medium under endoscopic and fluoroscopic control until waist disappearance and/or maximal balloon pressure. After dilation stones were extracted with the aid of standard accessories and techniques. Outcomes and adverse events were recorded. Results A total of 730 patients with common bile duct stones were admitted for ERCP in our institution. 123 (16,8%) patients were submitted to EPLBD after sphincterotomy. The mean age was 56 years (22-98) and 77 were female (63%). The size of the stones ranged from 13 to 30mm. Initial procedure success rate without mechanical lithitripsy was 83% (102/123). In further 4 patients (3,2%) mechanical lithotripsy was used with 75% success rate (3/4). For the remaining 17 patients, mechanical litotripsy was not available and a 10Fr biliary stent was introduced to prevent obstruction and cholangitis. The total adverse events rate was 3,2%. There were 2 cases of perforation with 20mm balloon (1,6%), both treated conservatively, and two cases of mild acute pancreatitis (1,6%). None of the patients presented bleeding that required transfusion or hospitalization. Conclusion EPLBD after sphincterotomy is a safe and effective technique for the management of large bile duct stones and it avoids mechanical lithotripsy in the majority of cases.DDW, San Diego - CA - USA; 05/2012
