Efficacy and safety of endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy in obese subjects with Non-Alcoholic SteatoHepatitis (NASH): study protocol for a randomized controlled trial (TESLA-NASH study)

Abstract

Background Non-alcoholic steatohepatitis (NASH) is frequently associated with obesity, and its standard treatment is weight loss with diet and exercise; a dy% weight reduction has been associated with improvement in liver histological and analytical abnormalities. However, less than 25% of subjects achieve this goal. Laparoscopic sleeve gastrectomy (LSG) represents the most common procedure of bariatric surgery, providing effective weight loss and improvement in comorbidities such as NASH, but it is associated with several postoperative complications. Endoscopic bariatric techniques are currently on the rise as a new tool in the fight against obesity, offering patients an alternative to more invasive surgery. However, their efficacy and safety compared with LSG is unclear. Methods The TESLA-NASH study is a randomized, controlled, open-label, unicentric clinical trial with a medical device. The aim of this study is to evaluate and compare the efficacy and safety of endoscopic sleeve gastroplasty (ESG) versus laparoscopic sleeve gastrectomy (LSG) in liver histology improvement of patients with obesity +/− metabolic syndrome and NASH. A total of 30 patients will be randomized 1:1 to the experimental or control group. Discussion LSG is an effective treatment for weight reduction and for the remission of hepatic alterations. However, LSG is associated with acute and chronic postoperative complications. Bariatric endoscopic techniques promise less invasive and more cost-effective approaches to the treatment of obesity and metabolic comorbidities. ESG represents one of the most promising novel endoscopic interventions and it is mainly proposed for patients with mild-to-moderate obesity, but there are still no guidelines that specify its applicability criteria. This clinical trial will help us apply different tactics to the treatment of obesity and NASH. Trial registration ClinicalTrials.gov NCT04060368. Registered on Nov 15, 2019.

Atherosclerosis and Non-Alcoholic Fatty Liver Disease

“…Although NAFLD is frequently associated with obesity, and its standard treatment is weight loss with diet, exercise, and medical treatments, some patients do not achieve this goal. 114 So, another option as laparoscopic sleeve gastrectomy (LSG) represents the most common bariatric surgery procedure, providing effective weight loss and improvement in comorbidities such as NAFLD. LSG is an effective treatment for weight reduction and for the remission of hepatic alterations.…”

“…However, LSG is associated with acute and chronic postoperative complications. 114 Bariatric endoscopic techniques promise less invasive and more cost-effective approaches to the treatment of obesity and metabolic comorbidities. 114…”

“…114 Bariatric endoscopic techniques promise less invasive and more cost-effective approaches to the treatment of obesity and metabolic comorbidities. 114…”

Pathophysiological Mechanisms in Non-Alcoholic Fatty Liver Disease: From Drivers to Targets

“…On the other hand, a recent and prospective study with 180 patients who underwent hepatic biopsy before bariatric surgery, and both at 1 and 5 years afterwards, observed NASH resolution and fibrosis improvement in 84% and 70% of the patients, respectively, at the longest time [ 187 ]. These data suggest a great impact of bariatric surgery in hepatic histology improvement, although it is not considered a first-line therapy due to the associated high risk [ 188 ]. Currently, some endoscopic techniques which are not only less invasive, but also comprise less complications and costs, are being developed, accomplishing similar gastric restriction than that obtained with surgery.…”

“…However, none of these methods are currently accepted as treatment for NASH. Despite this, there are some ongoing clinical trials on this field (NCT03426111 and NCT04060368) that may change the management of patients with NASH and obesity [ 188 ]. Preliminary results suggest that endoscopic sleeve gastroplasty could emerge as an effective and safe procedure, since therapeutic body weight reduction (i.e., >10%), improvement of biochemical parameters, and NAS score decrease were achieved [ 34 , 189 ].…”