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)

Lucía Lavín-Alconero, Tatiana Fernández-Lanas, Paula Iruzubieta-Coz, Maria Teresa Arias-Loste, Juan Carlos Rodriguez-Duque, Coral Rivas, Maria Luisa Cagigal, Coral Montalbán, Antonio Lopez Useros, Ana Álvarez-Cancelo, Mar García-Saiz, Javier Crespo-García, Lucía Lavín-Alconero, Tatiana Fernández-Lanas, Paula Iruzubieta-Coz, Maria Teresa Arias-Loste, Juan Carlos Rodriguez-Duque, Coral Rivas, Maria Luisa Cagigal, Coral Montalbán, Antonio Lopez Useros, Ana Álvarez-Cancelo, Mar García-Saiz, Javier Crespo-García

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.

Keywords: Bariatric endoscopy; Bariatric surgery; Endoscopic sleeve gastroplasty; Laparoscopic sleeve gastrectomy; NAFLD; NASH; Obesity.

Conflict of interest statement

Javier Crespo reports grants and research support from Gilead Sciences, AbbVie, MSD, Shionogi, and Intercept Pharmaceuticals (all outside the submitted work) and is a speaker for Gilead Sciences and AbbVie. The other authors declare that they have no competing interests.

© 2021. The Author(s).

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