An interventional study of Laparoscopic sleeve gastrectomy and Endoscopic sleeve gastroplasty in Obesity (Disorder) and Metabolic Disorders, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
Obesity is a chronic disease with a rapidly increasing prevalence, expected to affect up to 25% of the French population by 2030, and is associated with significant morbidity, mortality, and healthcare burden. Bariatric surgery, including sleeve gastrectomy and gastric bypass, remains the standard treatment for severe obesity but is irreversible and carries procedural risks.
Less invasive alternatives have emerged, including pharmacological treatments (GLP-1 receptor agonists and multi-agonists) and endoscopic approaches such as endoscopic sleeve gastroplasty (ESG), which have shown efficacy in weight loss and metabolic improvement, although drug therapies are limited by weight regain after discontinuation.
Sleeve gastrectomy, the most frequently performed bariatric procedure in France, induces weight loss through gastric restriction and hormonal changes, including decreased ghrelin and increased GLP-1 and PYY, along with accelerated gastric emptying.
ESG is a minimally invasive endoscopic technique with mechanisms that remain incompletely understood, likely involving gastric restriction, altered gastric emptying, and hormonal and microbiome-related effects.
Bariatric outcomes are driven by complex interactions between gastric anatomy, motility, hormonal regulation, and the gut microbiome. An integrated evaluation of these parameters is needed to better understand response variability after intervention.
A total of 40 patients will be enrolled (20 per group).
Obesity is a chronic disease with increasing prevalence, projected to affect up to 25% of the French population by 2030, and is associated with significant morbidity, mortality, and healthcare burden. Bariatric surgery, including sleeve gastrectomy and gastric bypass, remains the reference treatment for severe obesity but is irreversible and associated with procedural risks.
Less invasive alternatives have emerged, including pharmacological treatments (GLP-1 receptor agonists and multi-agonists) and endoscopic procedures such as endoscopic sleeve gastroplasty (ESG). These approaches have demonstrated efficacy in weight loss and metabolic improvement, although pharmacological treatments are limited by weight regain after discontinuation and reduced long-term adherence.
Sleeve gastrectomy, the most commonly performed bariatric procedure in France, induces weight loss through gastric restriction, hormonal changes (including reduced ghrelin and increased GLP-1 and PYY), and accelerated gastric emptying. In contrast, ESG is a minimally invasive endoscopic technique with mechanisms that remain incompletely understood, with emerging data suggesting delayed gastric emptying.
Beyond mechanical restriction, the metabolic effects of bariatric interventions involve complex interactions between gastric anatomy, motility, gut hormones, and the microbiome. Gastric emptying, a key determinant of satiety and hormonal response, differs between procedures and may contribute to variability in weight loss outcomes. Hormonal adaptations and microbiome changes after ESG remain insufficiently characterized.
This study adopts an integrative approach combining gastric volumetry, gastric emptying assessment, hormonal profiling, and microbiome analysis to better understand mechanisms of response and inter-individual variability after bariatric interventions.
A total of 40 patients will be enrolled (20 per group), with treatment allocation determined by a multidisciplinary team. Participants will undergo serial assessments including blood sampling, standardized meal test hormone measurements, CT-based gastric volumetry, and gastric emptying scintigraphy. Endoscopic biopsies will be performed at 12 months in the ESG group, while gastroscopy in the surgical group will be performed only if clinically indicated.
The study aims to improve mechanistic understanding of bariatric interventions, identify predictors of response, and support personalized therapeutic strategies in obesity management.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindication to general anesthesia, including:
Intervention assigned during a multidisciplinary team meeting (MDT).
Procedure: Laparoscopic sleeve gastrectomy
Intervention assigned during a multidisciplinary team meeting (MDT).
Procedure: Endoscopic sleeve gastroplasty
Participants undergo laparoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.
Participants undergo endoscopic sleeve gastrectomy with 12-month follow-up including clinical, metabolic, imaging, hormonal and microbiota assessments.
Gastric emptying evolution after endoscopic sleeve gastroplasty versus surgical sleeve
Assessment of gastric emptying using scintigraphic measurement to compare physiological changes induced by endoscopic sleeve gastroplasty versus surgical sleeve.
Time frame: Baseline to 12 months post-intervention
Gastric microbiota diversity assessed by 16S rRNA sequencing
Gastric microbiota diversity assessed from gastric biopsies using 16S rRNA gene sequencing and expressed using the Shannon diversity index.
Time frame: Baseline to 12 months
Total Body Weight Loss (TBWL)
Total Body Weight Loss expressed as percentage (%) of initial body weight.
Time frame: Baseline, 1, 3, 6 and 12 months
Postprandial GLP-1 plasma concentration after standardized meal test
GLP-1 plasma concentrations measured at T0, T30, T90 and T180 following a standardized meal test. Results expressed in pmol/L.
Time frame: Baseline, 1, 3, 6 and 12 months
Correlation between gastric emptying and GLP-1 plasma levels
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and GLP-1 plasma concentrations measured after a standardized meal test.
Time frame: Baseline to 12 months
Correlation between gastric emptying and PYY plasma levels
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and PYY plasma concentrations measured after a standardized meal test.
Time frame: Baseline to 12 months
Correlation between gastric emptying and GIP plasma levels
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and GIP plasma concentrations measured after a standardized meal test.
Time frame: Baseline to 12 months
Correlation between gastric emptying and ghrelin plasma levels
Correlation between gastric emptying assessed by scintigraphy (gastric half-emptying time in minutes) and ghrelin plasma concentrations measured after a standardized meal test
Time frame: Baseline to 12 months
Gastric volume assessed by CT-based volumetry
Measurement of gastric volume using CT scan (gastroscanner) with volumetric reconstruction. Results expressed in milliliters (mL).
Time frame: Baseline, 1 month and 12 months
Effect of gastric emptying time on total body weight loss
Total body weight loss (%), analyzed according to gastric half-emptying time (minutes) assessed by gastric scintigraphy using linear regression.
Time frame: Baseline to 12 months
Effect of postprandial GLP-1 plasma concentration on total body weight loss
Total body weight loss (%), analyzed according to plasma GLP-1 concentration (pmol/L) measured after a standardized meal test using biochemical assay and linear regression.
Time frame: Baseline to 12 months
Effect of gastric volume on total body weight loss
Total body weight loss (%), analyzed according to gastric volume (mL) measured by computed tomography (CT scan) using linear regression.
Time frame: Baseline to 12 months
Effect of gastric microbiota diversity on total body weight loss
Total body weight loss (%), analyzed according to gastric microbiota diversity assessed using the Shannon diversity index derived from 16S rRNA gene sequencing using linear regression.
Time frame: Baseline to 12 months
Safety and tolerability of endosleeve versus surgical sleeve
Incidence of adverse events including digestive, hemorrhagic, infectious, anesthetic and nutritional complications, rehospitalization and mortality.
Time frame: From intervention to 12 months
Plan to share: No
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Assistance Publique - Hôpitaux de Paris