Endoscopic sleeve gastrectomy vs traditional bariatric surgery: A paradigm shift in managing metabolic dysfunction-associated steatohepatitis and cirrhosis?

Table 3 Overview of current clinical trials and registries

Trial/registry1	Design and population	Primary focus	Key findings/status	Notes	Ref.
NASH-APOLLO, NCT03426111	RCT, Spain; 40 patients with biopsy-confirmed MASH. ESG + lifestyle vs sham endoscopy + lifestyle	Weight loss and histological changes	ESG improved weight, liver stiffness, and steatosis; histologic gains only with > 10% TBWL	First RCT of ESG in MASH with histologic endpoints	[55]
TESLA-NASH, NCT04060368	RCT; 30 patients with MASH. ESG vs LSG	Histological resolution of MASH, all-cause mortality and liver-related outcomes in obese subjects with MASH	Ongoing	First head-to-head ESG vs LSG in MASLD/MASH	[85]
University of West Virginia NCT05507151	Single-arm prospective pilot; 30 patients with MASLD or MASH. Excludes cirrhosis/portal hypertension	ESG safety profile, quality of life assessment, anthropometric, metabolic, and biochemical changes in obese subjects with MASH	Ongoing	Focus on early-stage disease; reflects cautious ESG use in advanced liver disease	[84]
Mass general brigham, NCT04820036	Prospective study; 20 patients with MASH and advanced fibrosis. Includes EUS-guided liver biopsy and portal pressure monitoring	Effect of ESG on fibrosis and hemodynamics, insulin resistance, quality of life assessment	Ongoing	Unique data on portal pressure and advanced disease	[86]
BRAVES, NCT03524365	RCT; 288 participants with biopsy-proven MASH. Compared LSG and RYGB vs intensive medical therapy in MASH	Histological improvement and weight loss	LSG/RYGB superior to medical therapy in MASH resolution	Not ESG-specific, but remains benchmark for surgical outcomes in MASH	[40]
Surgical registries	MBSAQIP, Scandinavian Obesity Registry	Liver-related and metabolic outcomes post-bariatric surgery	Contributing real-world data on long-term outcomes	No ESG-specific global registry exists

¹NCT numbers correspond to ClinicalTrials.gov identifiers.

ESG: Endoscopic sleeve gastroplasty; EUS: Endoscopic ultrasound; LSG: Laparoscopic sleeve gastrectomy; MASH: Metabolic dysfunction-associated steatohepatitis; MASLD: Metabolic dysfunction-associated steatotic liver disease; MBSAQIP: Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program; RCT: Randomized controlled trial; RYGB: Roux-en-Y gastric bypass; TBWL: Total body weight loss.