Dataset Information

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.

SUBMITTER: Lavin-Alconero L

PROVIDER: S-EPMC8556907 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe laparoscopic sleeve gastrectomy (LSG) and the incisionless endoscopic sleeve gastroplasty (ESG) weight loss procedures require further investigation of their efficacy, safety and patient-centered outcomes in the Australian setting.MethodsThe aim was to examine the 6- and 12-month weight loss efficacy, safety, and weight-related quality of life (QoL) of adults with obesity who received the ESG or LSG bariatric procedure with 12+ months of adjuvant multidisciplinary pre- and postprocedural support. Data were from a two-arm prospective cohort study that followed patients from baseline to 12-months postprocedure from a medical center in Queensland. Percent excess weight loss (%EWL) was the primary outcome. Secondary outcomes were body composition (fat mass, fat-free mass, android:gynoid ratio, bone mineral content) via dual energy X-ray absorptiometry, weight-related QoL, lipid, glycemic, and hepatic biochemistry, and adverse events.Results16 ESG (19% attrition; 81.2% female; aged:41.4 (SD: 10.4) years; BMI: 35.5 (SD: 5.2) kg/m2) and 45 LSG (9% attrition; 84.4% female; aged:40.4 (SD: 9.0) years; BMI: 40.7 (SD: 5.6) kg/m2) participants were recruited. At 12-months postprocedure, ESG %EWL was 57% (SD: 32%; p < 0.01) and LSG %EWL was 79% (SD: 24%; p < 0.001). ESG and LSG cohorts improved QoL (19.8% in ESG [p > 0.05]; 48.1% in LSG [p < 0.05]), liver function (AST: - 4.4 U/L in ESG [p < 0.05]; - 2.7 U/L in LSG [p < 0.05]), HbA1c (- 0.5% in ESG [p < 0.05]; - 0.1% in LSG [p < 0.05]) and triglycerides (- 0.6 mmol/L in ESG [p > 0.05]; - 0.4 mmol/L in LSG [P < 0.05]) at 12-months. Both cohorts reduced fat mass (p < 0.05). The ESG maintained but LSG decreased fat-free mass at 6-months (p < 0.05); and both cohorts lost fat-free mass at 12-months (p < 0.05). There were no adverse events directly related to the procedure. The ESG reported 25% mild-moderate adverse events possibly related to the procedure, and the LSG reported 27% mild-severe adverse events possibly related to the procedure.ConclusionsIn this setting, the ESG and LSG were safe and effective weight loss treatments for obese adults alongside multidisciplinary support. Patients who elected the ESG maintained fat-free mass at 6-months but both cohorts lost fat-free mass at 12-months postprocedure. Patients who elected the LSG had large and significant improvements to weight-related quality of life. Further well-powered studies are required to confirm these findings.Trial registrationThis study was registered prospectively at the Australia New Zealand Clinical Trials Registry on 06/03/2018, Registration Number ACTRN12618000337279 .

Project description:ImportanceObesity is a disease with a large socioeconomic burden. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric procedure with wide global adoption. More recently, new weight-loss medications, such as glucagon-like peptide-1 receptor agonists (eg, semaglutide), have attracted increased attention due to their efficacy. However, their cost-effectiveness over an extended period compared with ESG is a critical gap that needs to be better explored for informed health care decision-making.ObjectiveTo assess the cost-effectiveness of semaglutide compared with ESG over 5 years for individuals with class II obesity.Design, setting, and participantsThis economic evaluation study, conducted from September 1, 2022, to May 31, 2023, used a Markov cohort model to compare ESG and semaglutide, with a no-treatment baseline strategy. The study comprised adult patients in the US health care system with class II obesity (body mass index [BMI] of 35-39.9). The base case was a 45-year-old patient with class II obesity (BMI of 37). Patients undergoing ESG were subjected to risks of perioperative mortality and adverse events with resultant costs and decrement in quality of life.InterventionsStrategies included treatment with semaglutide and ESG.Main outcomes and measuresCosts (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $100 000/QALY. A 5-year time horizon with a cycle length of 1 month with a 3% discount rate was used. Probabilities, costs, and quality-of-life estimates of the model were derived from published literature. One-way, 2-way, and probabilistic sensitivity analyses were also performed.ResultsThe model found that ESG was more cost-effective than semaglutide over a 5-year time horizon, with an ICER of -$595 532/QALY. Endoscopic sleeve gastroplasty added 0.06 QALYs and reduced total cost by $33 583 relative to semaglutide. The results remained robust on 1-way and probabilistic sensitivity analyses. Endoscopic sleeve gastroplasty sustained greater weight loss over 5 years vs semaglutide (BMI of 31.7 vs 33.0). To achieve nondominance, the annual price of semaglutide, currently $13 618, would need to be $3591.Conclusions and relevanceThis study suggests that ESG is cost saving compared with semaglutide in the treatment of class II obesity. On price threshold analyses, a 3-fold decrease in the price of semaglutide is needed to achieve nondominance.

Project description:BACKGROUND:Laparoscopic sleeve gastrectomy (LSG) modifies the upper gastrointestinal tract motility. Controversial data currently exist. The aim of the study was to evaluate esophageal motility before and after LSG. PATIENTS AND METHODS:Morbid obese patients scheduled for LSG underwent reflux symptoms evaluation and manometry preoperatively and postoperatively. The preoperative and postoperative results were compared and analyzed. RESULTS:Eighteen patients were enrolled. Heartburn and regurgitation improved in 38.9% and 11.1% of the patients, but deteriorated in 11.1% and 27.8% of the patients, respectively. Lower esophageal sphincter (LES) total length decreased postoperatively (p=0.002). Resting and residual pressures tended to decrease postoperatively (mean difference [95% confidence interval]: -4 [-8.3/0.2] mmHg, p=0.060; -1.4 [-3/0.1] mmHg, p=0.071, respectively). Amplitude pressure decreased from 95.7±37.3 to 69.8±26.3 mmHg at the upper border of LES (p=0.014), and tended to decrease at the distal esophagus from 128.5±30.1 to 112.1±35.4 mmHg (p=0.06) and mid-esophagus from 72.7±34.5 to 49.4±16.7 mmHg (p=0.006). Peristaltic normal swallow percentage increased from 47.2±36.8 to 82.8±28% (p=0.003). Postoperative regurgitation was strongly negatively correlated with LES total length (Spearman's r=-0.670). When groups were compared according to heartburn status, statistical significance was observed between the groups of improvement and deterioration regarding postoperative residual pressure and postoperative relaxation (p<0.002, p<0.002, respectively). With regard to regurgitation status, there was statistically significant difference between groups regarding preoperative amplitude pressure at the upper border of LES (p<0.056). CONCLUSION:Patients developed decreased LES length and weakened LES pressure after LSG. Esophageal body peristalsis was also affected in terms of decreased amplitude pressure, especially at the upper border of LES. Nevertheless, body peristalsis was normalized postoperatively. LSG might not deteriorate heartburn. Regurgitation might increase following LSG due to shortening of LES length, particularly in patients with range of preoperative amplitude pressure at the upper border of LES of 38.9-92.6 mmHg.