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EndoBarrier®: a Safe and Effective Novel Treatment for Obesity and Type 2 Diabetes?
Patel, N, Mohanaruban, A, Ashrafian, H, Le Roux, C, Byrne, J, Mason, J, Hopkins, J, Kelly, J, Teare, J
Obesity surgery. 2018;(7):1980-1989
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Abstract
BACKGROUND AND AIMS Obesity associated with diabetes mellitus is a significant worldwide problem associated with considerable health care costs. Whilst surgical intervention is effective, it is invasive, costly and associated with complications. This study aims to evaluate the safety and efficacy of the EndoBarrier®, a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients. MATERIALS AND METHODS This was a multi-centre, non-randomised trial recruiting obese patients with type 2 diabetes from three sites in the UK. Eligible participants had a BMI of 30-50 kg/m2 and HbA1c levels of 7.5-10%. The study comprised a 12-month period with the EndoBarrier® inserted and a 6-month follow-up period after it had been explanted. The primary study outcomes were weight, BMI, HbA1c levels and fasting insulin and glucose levels. RESULTS Forty-five patients were recruited and 31 patients (69%) completed the 12-month study period. Significant reductions in weight (95%CI 0.62-29.38; p < 0.05) and BMI (95%CI 1.1-8.7; p < 0.005) were documented 12 months after device insertion. The mean HbA1c was significantly reduced (95%CI 0.1-1.6; p < 0.05) after the device insertion period and reductions in metabolic parameters (fasting insulin and glucose levels) were also documented during the study. Adverse events were also assessed in all patients, the vast majority of which were reported as mild. CONCLUSIONS The EndoBarrier® appears to be a safe and effective treatment strategy in overweight patients with poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery.
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Endoscopic Therapies for Gastroparesis.
Su, A, Conklin, JL, Sedarat, A
Current gastroenterology reports. 2018;(6):25
Abstract
PURPOSE OF REVIEW Gastroparesis remains a difficult-to-treat disease with limited therapeutic options. Though patients often have a common syndrome of stereotypic symptoms, the underlying pathophysiology is heterogeneous, often leading to variable treatment responses. Due to limitations in medical and surgical therapies, endoscopic options have been increasingly explored. These options can be broadly categorized into pyloric-directed therapy, non-pyloric-directed therapy, and nutritional support. In this review, we will highlight current and emerging endoscopic options, such as gastric per-oral endoscopic myotomy (G-POEM). RECENT FINDINGS Early retrospective studies on G-POEM offer encouraging results up to one year out, with an acceptable safety profile. Other pyloric-directed therapies, such as pyloric dilation and stenting, have also been explored. While emerging endoscopic therapeutic options are encouraging, efficacy will likely depend on a better characterization of underlying pathophysiology and improved patient selection. Future prospective, controlled studies are needed.
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Performance of the over-the-scope clip system in the endoscopic closure of iatrogenic gastrointestinal perforations and post-surgical leaks and fistulas.
Iabichino, G, Eusebi, LH, Palamara, MA, Arena, M, Pellicano, R, Consolo, P, Fagoonee, S, Amato, L, Opocher, E, Barabino, M, et al
Minerva gastroenterologica e dietologica. 2018;(1):75-83
Abstract
The increased invasiveness of endoscopic procedures and complex surgical interventions has resulted in an increased number of gastrointestinal iatrogenic defects, such as perforations, leak and fistulas. The conventional treatment for these gastrointestinal defects is surgery, with considerable risks especially in emergency situations and in patients with comorbidities. The Ovesco over-the-scope clip (OTSC) system (Ovesco Endoscopy AG, Tübingen, Germany) and more recently, the Padlock Clip™ (Aponos Medical, Kingston, NH, USA) have shown promising results in the treatment of gastrointestinal defects. Several case reports and case series have demonstrated the efficacy of the OTSC system for the closure of full-thickness defects. Clinical success is best achieved in patients undergoing closure of a perforation or a leak. Closure of fistulas remains a clinical challenge since fibrosis or necrotic and inflamed tissue surrounding lesions may cause clip failure. Over-the-scope clips are a less invasive endoscopic option for managing patients with gastrointestinal defects before a more invasive surgical approach is attempted. Moreover, a failed attempt of OTSC deployment does not preclude subsequent surgical treatment.
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Decreasing Use of Percutaneous Endoscopic Gastrostomy Tube Feeding in Japan.
Komiya, K, Usagawa, Y, Kadota, JI, Ikegami, N
Journal of the American Geriatrics Society. 2018;(7):1388-1391
Abstract
OBJECTIVES To identify trends in percutaneous endoscopic gastrostomy (PEG) tube placement and intravenous hyperalimentation (IVH) in nonhospital settings (as a potential alternative to tube feeding for nutrition) and to summarize published reports concerning the decision-making process for PEG placement. DESIGN National survey and systematic review. SETTING Japan. PARTICIPANTS All Japanese people. MEASUREMENTS Data on numbers of individuals with a PEG tube and IVH were obtained from the website of the Japanese Ministry of Health, Labour, and Welfare and published reports concerning the decision-making process for PEG placement in Japan were summarized. RESULTS The number of PEG tube placements peaked in 2007 and has been decreasing since Japan experienced the Great East Japan Earthquake in 2011. A further decline was seen in 2015 after the Japanese Ministry of Health, Labour and Welfare revised the fee schedule in 2014. More than half of individuals who had tubes were aged 80 and older during the years observed. In contrast, the number of individuals receiving IVH was lowest in the same year as PEG tube placement peaked and has been increasing ever since. Four studies reported that the decision-making process included consideration of not only the underlying disease, but also the individual's age and social barriers and the physician's personal philosophy. CONCLUSION The number of PEG tube placements has been decreasing since its peak in 2007, and the number of individuals receiving IVH has been increasing. Many factors influence the decision-making process for PEG tube placement. Physicians in Japan may be realizing that there is little evidence to support the use of tube feeding in frail elderly adults.
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Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial.
Monrroy, H, Vargas, JI, Glasinovic, E, Candia, R, Azúa, E, Gálvez, C, Rojas, C, Cabrera, N, Vidaurre, J, Álvarez, N, et al
Gastrointestinal endoscopy. 2018;(4):986-993
Abstract
BACKGROUND AND AIM Upper GI endoscopy (UGE) is essential for the diagnosis of gastrointestinal diseases. Mucus and bubbles may decrease mucosal visibility. The use of mucolytics could improve visualization. Our aim was to determine whether premedication with simethicone or simethicone plus N-acetylcysteine is effective in improving visibility during UGE. METHODS This was a randomized, double-blinded, placebo-controlled trial with 2 control groups: no intervention and water 100 mL (W); and 3 intervention groups: simethicone 200 mg (S); S + N-acetylcysteine (NAC) 500 mg (S+NAC500); and S + NAC 1000 mg (S+NAC1000). The solution was ingested 20 minutes before UGE. Gastric visibility was evaluated in 4 segments with a previously described scale. A score of less than 7 points was defined as adequate visibility (AV). Water volume was used to improve visibility, and adverse reactions were evaluated as a secondary outcome. Multiple group comparison was performed using non-parametric one-way analysis of variance (ANOVA). RESULTS Two hundred thirty patients were included in the study, 68% female, mean age 49 years. The most common indication for UGE was epigastric pain/dyspepsia (33%). AV was more frequent in the S+NAC500 and S+NAC1000 groups (65% and 67%) compared with no intervention (44%, P = .044) and water (41%, P = .022). The gastric total visibility scale (TVS) was significantly better in the S+NAC500 and S+NAC1000 groups compared with water (P = .03 and P = .008). Simethicone was not different from no intervention and water. S+NAC1000 required less water volume to improve visibility. No adverse reactions from the study drugs were observed. CONCLUSIONS Premedication with S+NAC500 and S+NAC1000 improves visibility during UGE. The use of simethicone did not show improvements in gastric visibility. TVS was worse in patients using water alone. (Clinical trial registration number: NCT 01653171.).
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Endoscopic Dilation of Bariatric RNY Anastomotic Strictures: a Systematic Review and Meta-analysis.
Baumann, AJ, Mramba, LK, Hawkins, RB, Carpenter, AM, Fleisher, MS, Ayzengart, AL, Estores, DS
Obesity surgery. 2018;(12):4053-4063
Abstract
Gastrojejunostomy anastomotic strictures are a complication of Roux-en-Y gastric bypass surgery without an established treatment guideline. A systematic review and meta-analysis were performed to determine the safety and efficacy of endoscopic dilation in their management. PubMed, Web of Science, and Cochrane Central (1994-2017) were searched. Data was analyzed with random effects meta-analysis and mixed effects meta-regression. Twenty-one observational studies (896 patients) were included. The stricture rate for laparoscopic patients was 6% (95% CI, 5-9%). Only 38% (95% CI, 30-47%) required greater than one dilation. Symptom improvement occurred in 97% (95% CI, 94-98%). The complication rate was 4% (95% CI, 3-6%). Endoscopic dilation of GJA strictures is safe, effective, and sustaining. This study can guide endoscopists in the treatment of a common bariatric surgical complication.
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Percutaneous sonographically assisted endoscopic gastrostomy for difficult cases with interposed organs.
Moriwaki, Y, Otani, J, Okuda, J, Zotani, H, Kasuga, S
Nutrition (Burbank, Los Angeles County, Calif.). 2018;:100-104
Abstract
OBJECTIVES The aim of this retrospective observational study was to clarify the usefulness and safety of percutaneous sonographically assisted endoscopic gastrostomy or duodenostomy (PSEGD) using the introduction method. METHODS The information for the sequential 22 patients who could not undergo standard percutaneous endoscopic gastrostomy (PEG) and underwent PSEGD for 3 y was extracted and was reviewed. In standard PEG, we performed pushing out of the stomach from the mediastinum and full distention to adhere the gastric wall to the peritoneal wall without interposing of the intraperitoneal tissues by air inflation and a turning-over procedure of the endoscope, four-point square fixation of the stomach to the peritoneal wall by using a Funada-style gastric wall fixation kit under diaphanoscopy, extracorporeal thumb pushing, and in difficult cases extracorporeal ultrasound guidance, and if necessary confirmation of fixation of the gastric wall to the peritoneal wall and placement of the PEG tube without any interposed tissues by using ultrasound. RESULTS Twenty-one patients (95.5%) successfully underwent PSEGD. Early complications (more than grade 2 in Clavien-Dindo classification) just after the procedure occurred in one case (active oozing). We did not encounter a case with mispuncture of the intraperitoneal organs and tissues. Delayed complications occurring within 1 mo were pneumonia in five patients, including death in three cases; bleeding from puncture site in two patients; and atrial fibrilation in one patient. CONCLUSION PSEGD using the introduction method is a useful procedure for difficult patients in whom intraperitoneal organ or tissue is suspected to be interposed between the abdominal wall and stomach.
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Percutaneous endoscopic gastrostomy, body weight loss and survival in amyotrophic lateral sclerosis: a population-based registry study.
Fasano, A, Fini, N, Ferraro, D, Ferri, L, Vinceti, M, , , Mandrioli, J
Amyotrophic lateral sclerosis & frontotemporal degeneration. 2017;(3-4):233-242
Abstract
OBJECTIVE To assess the role of percutaneous endoscopic gastrostomy (PEG) insertion, and its timing, on ALS survival, and to study prognostic factors of survival before and after PEG placement in a population-based setting. METHODS In this observational population-based, registry study, we enrolled patients with newly- diagnosed ALS, according to the El Escorial revised criteria, who were resident in the Emilia Romagna Region, and who developed severe dysphagia needing enteral nutritional support. The primary outcome measure was tracheostomy-free survival after PEG recommendation. RESULTS There were 210 patients needing PEG, out of an incident cohort of 545 patients from the Emilia Romagna Registry for ALS, who were diagnosed between 2009 and 2013. One hundred and ninety-three patients were included in the study, and 17 were excluded because they were already tracheostomized at the time of PEG placement. Of the 193 patients included in the study, 152 underwent PEG, whereas 41 did not undergo the procedure. Patients who did not undergo PEG, among the eligible ones, had the same tracheostomy-free survival from onset as patients who did (25 vs. 32 months, p = 0.21). Tracheostomy-free survival from PEG recommendation was greater in patients who underwent PEG placement than in patients who did not (6 vs. 2 months, p = 0.008). Median tracheostomy-free survival from PEG insertion was eight months (95% CI5-12); 30 days after PEG placement, survival was 89.60%. At Cox multivariable analysis, the hazard of death or tracheostomy after PEG insertion was significantly influenced by the difference between BMI at the time of the PEG procedure and BMI at diagnosis (HR 1.05, 95% CI 1.02-1.08; p = 0.002). The hazard of death or tracheostomy was not affected by the timing of PEG insertion. CONCLUSIONS The present study, although it has some limitations, suggests a gain of tracheostomy-free survival from the time of PEG recommendation for patients who undergo PEG placement, and, among patients who undergo PEG, a greater survival if PEG is inserted before a significant weight loss occurs, and if nutritional support avoids further weight loss. Should this association between prevention of weight loss and better clinical outcome be confirmed by further studies, it would have important implications for disease management.
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Novel Nonsurgical Endoscopic Approaches for the Treatment of Obesity.
Hurt, RT, Frazier, TH, Mundi, MS
Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition. 2017;(4):493-501
Abstract
Globally, obesity is a leading cause of preventable death and is associated with >60 comorbid medical conditions, including 10 types of cancer that are strongly associated with body mass index. There are a number of traditional obesity treatments-for example, lifestyle management (eg, decreased caloric intake and increased expenditure), pharmacotherapy, and bariatric surgery. Recently, endoscopic approaches have emerged as a viable alternative for weight loss. Endoscopically placed intragastric balloons were introduced in the early 1980s for the treatment of medically complicated obesity but, unfortunately, had high rates of complications, such as premature deflation leading to obstruction. Despite these shortcomings, these devices have experienced a renewal, with a second generation of improved devices being approved for clinical use in 2015. In addition to the intragastric balloons, there are a number of other endoscopic approaches to weight loss that are either Food and Drug Administration approved or undergoing evaluation (aspiration therapy, duodenal jejunal bypass sleeve). The current review examines the literature available and discusses the practical clinical considerations involved.
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Premedication with simethicone and N-acetylcysteine in improving visibility during upper endoscopy: a double-blind randomized trial.
Elvas, L, Areia, M, Brito, D, Alves, S, Saraiva, S, Cadime, AT
Endoscopy. 2017;(2):139-145
Abstract
Background and study aim Upper endoscopy is the most common method for the diagnosis of upper gastrointestinal tract diseases. The aim of this study was to determine whether premedication with simethicone or N-acetylcysteine improves mucosal visualization during upper endoscopy. Patients and methods This was a randomized, double-blind, placebo-controlled study of 297 patients scheduled for upper endoscopy who were premedicated 15 - 30 minutes before the procedure with: 100 mL of water (placebo, group A); water plus 100 mg simethicone (group B); water plus 100 mg simethicone plus 600 mg N-acetylcysteine (group C). The primary outcome measure was the quality of mucosal visualization (score: excellent, adequate or inadequate). Results The addition of simethicone (group B) or simethicone plus N-acetylcysteine to the water (group C) improved the visualization scores of endoscopies compared with water alone (group A). In particular, groups B and C produced a significantly higher percentage of endoscopies with excellent visualization for the esophagus (91.1 % and 86.7 %, respectively, vs. 71.4 % in group A; P < 0.001) and stomach (76.2 % and 74.5 % vs. 38.8 % in group A; P < 0.001). For the duodenum, the use of simethicone also showed an increase in the endoscopies with excellent visualization compared with water alone (85.1 % vs. 73.5 %; P = 0.042). There were no significant differences in scores between groups B and C or between gastric scores in patients with previous subtotal gastrectomy (B and C vs. A): 60.0 % and 42.1 % vs. 28.6 % (P = 0.14). The rate of reported lesions was higher in group B but without statistical significance. Conclusions Premedication with simethicone resulted in better mucosal visibility. Such premedication might improve diagnostic yield, and should be considered for standard practice. Trial registered at ClinicalTrials.gov (NCT02357303).