IFSO Bariatric Endoscopy Committee Evidence-Based Review and Position Statement on Endoscopic Sleeve Gastroplasty for Obesity Management.

Endoscopic Sleeve Gastroplasty Meta-analysis Obesity

Journal

Obesity surgery
ISSN: 1708-0428
Titre abrégé: Obes Surg
Pays: United States
ID NLM: 9106714

Informations de publication

Date de publication:
01 Nov 2024
Historique:
received: 08 09 2024
accepted: 16 09 2024
revised: 11 09 2024
medline: 1 11 2024
pubmed: 1 11 2024
entrez: 1 11 2024
Statut: aheadofprint

Résumé

Obesity is a significant global health issue. Metabolic and bariatric surgery (MBS) is the gold standard in the treatment of obesity due to its proven effectiveness and safety in the short and long term. However, MBS is not suitable for all patients. Some individuals are at high surgical risk or refuse surgical treatment, while others do not meet the criteria for MBS despite having obesity-related comorbidities. This gap has driven the development of endoscopic solutions like endoscopic sleeve gastroplasty (ESG), which offers a less invasive alternative that preserves organ function and reduces risks. A recent IFSO International Delphi consensus study highlighted that multidisciplinary experts agree on the utility of ESG for managing obesity in patients with class I and II obesity and for those with class III obesity who do not wish to pursue or qualify for MBS. This IFSO Bariatric Endoscopy Committee position statement aims to augment these consensus statements by providing a comprehensive systematic review of the evidence and delivering an evidence-based position on the value of ESG within the spectrum of obesity management. A comprehensive systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and Cochrane guidelines. Systematic Review: The systematic review included 44 articles encompassing 15,714 patients receiving ESG. The studies varied from large case series to cohort studies and a randomized controlled trial (RCT). The mean baseline BMI was 37.56 kg/m2. The review focused on weight loss outcomes and safety data. Time point Mean %EWL Mean %TBWL 6 months 48.04 15.66 12 months 53.09 17.56 18 months 57.98 16.25 24 months 46.57 15.2 36 months 53.18 14.07 60 months 45.3 15.9 These results demonstrate significant weight loss following ESG. The pooled serious adverse event (SAE) rate was 1.25%. This low rate of SAEs indicates that ESG is a relatively safe procedure. The quality of evidence from the included observational studies was assessed as very low, primarily due to the inherent limitations associated with observational study designs, such as potential biases and lack of randomization. In contrast, the quality of evidence from the single randomized controlled trial was rated as MODERATE, reflecting a more robust study design that provides a higher level of evidence despite some limitations. The IFSO Bariatric Endoscopy Committee, after conducting a comprehensive systematic review and meta-analysis, endorses endoscopic sleeve gastroplasty (ESG) as an effective and valuable treatment for obesity. ESG is particularly beneficial for patients with class I and II obesity, as well as for those with class III obesity who are not suitable candidates for metabolic bariatric surgery. ESG provides significant weight loss outcomes and demonstrates a favorable safety profile with a low rate of serious adverse events. Despite the limitations of the included observational studies, the randomized controlled trial included in the analysis reinforces the efficacy and safety of ESG and provides an evidence-based foundation for the position statement. Thus, the IFSO position statement supports and provides an evidence base for the role of ESG within the broader spectrum of obesity management.

Sections du résumé

BACKGROUND BACKGROUND
Obesity is a significant global health issue. Metabolic and bariatric surgery (MBS) is the gold standard in the treatment of obesity due to its proven effectiveness and safety in the short and long term. However, MBS is not suitable for all patients. Some individuals are at high surgical risk or refuse surgical treatment, while others do not meet the criteria for MBS despite having obesity-related comorbidities. This gap has driven the development of endoscopic solutions like endoscopic sleeve gastroplasty (ESG), which offers a less invasive alternative that preserves organ function and reduces risks. A recent IFSO International Delphi consensus study highlighted that multidisciplinary experts agree on the utility of ESG for managing obesity in patients with class I and II obesity and for those with class III obesity who do not wish to pursue or qualify for MBS. This IFSO Bariatric Endoscopy Committee position statement aims to augment these consensus statements by providing a comprehensive systematic review of the evidence and delivering an evidence-based position on the value of ESG within the spectrum of obesity management.
METHODS METHODS
A comprehensive systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and Cochrane guidelines.
RESULTS RESULTS
Systematic Review: The systematic review included 44 articles encompassing 15,714 patients receiving ESG. The studies varied from large case series to cohort studies and a randomized controlled trial (RCT). The mean baseline BMI was 37.56 kg/m2. The review focused on weight loss outcomes and safety data.
META-ANALYSIS METHODS
Time point Mean %EWL Mean %TBWL 6 months 48.04 15.66 12 months 53.09 17.56 18 months 57.98 16.25 24 months 46.57 15.2 36 months 53.18 14.07 60 months 45.3 15.9 These results demonstrate significant weight loss following ESG.
SAFETY RESULTS
The pooled serious adverse event (SAE) rate was 1.25%. This low rate of SAEs indicates that ESG is a relatively safe procedure.
QUALITY OF EVIDENCE METHODS
The quality of evidence from the included observational studies was assessed as very low, primarily due to the inherent limitations associated with observational study designs, such as potential biases and lack of randomization. In contrast, the quality of evidence from the single randomized controlled trial was rated as MODERATE, reflecting a more robust study design that provides a higher level of evidence despite some limitations.
CONCLUSIONS CONCLUSIONS
The IFSO Bariatric Endoscopy Committee, after conducting a comprehensive systematic review and meta-analysis, endorses endoscopic sleeve gastroplasty (ESG) as an effective and valuable treatment for obesity. ESG is particularly beneficial for patients with class I and II obesity, as well as for those with class III obesity who are not suitable candidates for metabolic bariatric surgery. ESG provides significant weight loss outcomes and demonstrates a favorable safety profile with a low rate of serious adverse events. Despite the limitations of the included observational studies, the randomized controlled trial included in the analysis reinforces the efficacy and safety of ESG and provides an evidence-based foundation for the position statement. Thus, the IFSO position statement supports and provides an evidence base for the role of ESG within the broader spectrum of obesity management.

Identifiants

pubmed: 39482444
doi: 10.1007/s11695-024-07510-z
pii: 10.1007/s11695-024-07510-z
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

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Auteurs

Barham K Abu Dayyeh (BKA)

Mayo Clinic, Rochester, USA. abudayyeh.barham@mayo.edu.
Gastroenterology and Advanced Endoscopy, Cedars-Sinai Health System, Los Angeles, USA. abudayyeh.barham@mayo.edu.

Christine Stier (C)

University Medical Centre Mannheim, Mannheim, Germany.

Aayed Alqahtani (A)

King Abdulaziz University, Jeddah, Saudi Arabia.

Reem Sharaiha (R)

Cornell University, Ithaca, USA.

Mohit Bandhari (M)

Sri Aurobindo Medical College and PG Institute, Indore, India.

Silvana Perretta (S)

IRCAD, Strasbourg, France.

Sigh Pichamol Jirapinyo (SP)

Brigham and Women's Hospital, Boston, USA.

Gerhard Prager (G)

Medical University of Vienna, Vienna, Austria.

Ricardo V Cohen (RV)

The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, San Paolo, Brazil.

Classifications MeSH