Bariatric-metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES). a multicentre, open-label, randomised trial

Background: Observational studies suggest that bariatric-metabolic surgery might greatly improve non-alcoholic steatohepatitis (NASH). However, the efficacy of surgery on NASH has not yet been compared with the effects of lifestyle interventions and medical therapy in a randomised trial. Methods: We did a multicentre, open-label, randomised trial at three major hospitals in Rome, Italy. We included participants aged 25-70 years with obesity (BMI 30-55 kg/m2), with or without type 2 diabetes, with histologically confirmed NASH. We randomly assigned (1:1:1) participants to lifestyle modification plus best medical care, Roux-en-Y gastric bypass, or sleeve gastrectomy. The primary endpoint of the study was histological resolution of NASH without worsening of fibrosis at 1-year follow-up. This study is registered at ClinicalTrials.gov, NCT03524365. Findings: Between April 15, 2019, and June 21, 2021, we biopsy screened 431 participants; of these, 103 (24%) did not have histological NASH and 40 (9%) declined to participate. We randomly assigned 288 (67%) participants with biopsy-proven NASH to lifestyle modification plus best medical care (n=96 [33%]), Roux-en-Y gastric bypass (n=96 [33%]), or sleeve gastrectomy (n=96 [33%]). In the intention-to-treat analysis, the percentage of participants who met the primary endpoint was significantly higher in the Roux-en-Y gastric bypass group (54 [56%]) and sleeve gastrectomy group (55 [57%]) compared with lifestyle modification (15 [16%]; p<0·0001). The calculated probability of NASH resolution was 3·60 times greater (95% CI 2·19-5·92; p<0·0001) in the Roux-en-Y gastric bypass group and 3·67 times greater (2·23-6·02; p<0·0001) in the sleeve gastrectomy group compared with in the lifestyle modification group. In the per protocol analysis (236 [82%] participants who completed the trial), the primary endpoint was met in 54 (70%) of 77 participants in the Roux-en-Y gastric bypass group and 55 (70%) of 79 participants in the sleeve gastrectomy group, compared with 15 (19%) of 80 in the lifestyle modification group (p<0·0001). No deaths or life-threatening complications were reported in this study. Severe adverse events occurred in ten (6%) participants who had bariatric-metabolic surgery, but these participants did not require re-operations and severe adverse events were resolved with medical or endoscopic management. Interpretation: Bariatric-metabolic surgery is more effective than lifestyle interventions and optimised medical therapy in the treatment of NASH. Funding: Fondazione Policlinico Universitario A Gemelli, Policlinico Universitario Umberto I and S Camillo Hospital, Rome, Italy

Young GI angle: Tips from improving your endoscopic technique.

The dream of every gastrointestinal (GI) fellow who is training in endoscopy is to become an expert endoscopist in all endoscopic techniques. In the past two decades, there has been an ‘endoscopic revolution’, with many new procedures that are becoming more and more complex and therapeutic. Today’s GI fellows are not limited to performing simple upper and lower GI procedures, but instead have an increasing interest in the dissection of large lesions, treatment of achalasia, palliation of malignancies of the GI tract, treatment of bilio-pancreatic disorders, endoscopic suturing and many other procedures. As all procedures are becoming more complex, training represents an increasingly important endeavour. [...

Endoscopic techniques for gastric neuroendocrine tumors: An update

Gastric neuroendocrine neoplasms (gNENs) are a rare type of gastric neoplasm, even if their frequency is increasing according to the latest epidemiologic revisions of the main registries worldwide. They are divided into three main subtypes, with different pathogeneses, biological behaviors, and clinical characteristics. GNEN heterogeneity poses challenges, therefore these neoplasms require different management strategies. Update the knowledge on the endoscopic treatment options to manage g-NENs. This manuscript is a narrative review of the literature. In recent years, many advances have been made not only in the knowledge of both the pathogenesis and the molecular profiling of gNENs but also in the endoscopic expertise towards innovative treatment options, which proved to be less aggressive without losing the capability of being radical. The endoscopic approach is increasingly applied in the field of gastrointestinal (GI) luminal neoplasms, and this is true not only for adenocarcinomas but also for gNENs. In particular, different techniques have been described for the endoscopic removal of suspected lesions, ranging from classical polypectomy (cold or hot snare) to endoscopic mucosal resection (both with "en bloc" or piecemeal technique), endoscopic submucosal dissection, and endoscopic full-thickness resection. GNENs comprise different subtypes of neoplasms with distinct management and prognosis. New endoscopic techniques offer a wide variety of approaches for GI localized neoplasms, which demonstrated to be appropriate and effective also in the case of gNENs. Correct evaluation of size, site, morphology, and clinical context allows the choice of tailored therapy in order to guarantee a definitive treatment

Food and Drug Administration and disposable duodenoscopes: A bolt from the blue for the rich or a godsend for the poor?

N/

The Boškoski-Costamagna ERCP Trainer: From dream to reality

We read with interest the article by Jovanovic et al. on the initial validation of a new mechanical endoscopic retrograde cholangiopancreatography (ERCP) training model [1]. Five trainees and five endoscopists, with and without ERCP experience, were involved in the evaluation of the model. The conclusion was that the model is a useful tool for ERCP training, particularly in improving the position of the scope, handling the wheels and the elevator, targeting the papilla, selectively cannulating the biliary and pancreatic ducts, extracting stones, and placing plastic and metal stents. ERCP is a complex procedure. Teaching the procedure is demanding, as it is difficult to explain the complexity of movements needed to maintain a correct and stable position in front of the papilla. In ERCP it is always a matter of keeping the right axis; if the axis is wrong, the chance of deep cannulation decreases dramatically. The basic issue is therefore how to teach movements to achieve a proper axis. A simple mechanical model to guide fellows on how to reach the correct position in front of the papilla, before they receive training on patients, was therefore imagined. The idea of this ERCP training model (the Boškoski-Costamagna ERCP Trainer; Cook Medical, Limerick, Ireland) arose at the end of 2010. The very first prototype was designed and then built using wires, parts from used accessories, plastic tubes, and sutures ([Fig. 1]). This prototype already had bile and pancreatic ducts, and could be assembled to present different grades of ERCP difficulty. A working team was then created, endorsed by the European Endoscopy Training Center in Rome, with the goal of implementing and further developing the prototype. ERCP training modules were organized, and feedback was collected in order to improve the model. Zoom ImageZoom Image Fig. 1 The Boškoski-Costamagna ERCP Trainer. a The original model (invented by Dr. Ivo Boškoski). b The original model with a duodenoscope. The ERCP simulator was immediately regarded as a useful tool by the trainees. Fellows learned how to move in front of the papilla in order to attain a proper axis and to achieve deep cannulation. Fellows became familiar with movements that are usually difficult to teach and to learn, without losing time in orientation in front of the papilla and without any risk. On the basis of these positive comments, the prototype was then further developed, produced, and distributed. The current version of the ERCP Trainer ([Fig. 2]) is light enough to be transported easily, may simulate different patient positions (prone, oblique, supine), and comes with several easily exchangeable modules featuring variations of the papillary anatomy and biliopancreatic junction. Zoom ImageZoom Image Fig. 2 The second-generation Boškoski-Costamagna ERCP Trainer, which is currently available. It was, indeed, with surprise that we read about this initial validation and the good results reported in the article by Jovanovic et al. These authors used the first generation of the Boškoski-Costamagna ERCP Trainer. The second generation of the ERCP Trainer is currently available, and a third, which will have more advanced features including fluoroscopy, is in development. Although our personal experience and that of Jovanovic et al. are encouraging, further trials are needed. For this purpose, a large multicenter study has been designed in order to identify the role of the training model and to prove the relevance of the ERCP Trainer in training programs

Needle-knife electrocautery: "give me a lever and I will move the world"

Needle-knife electrocautery: "give me a lever and I will move the world