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Original research
Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial
  1. Vincent Huberty1,
  2. Ivo Boskoski2,
  3. Vincenzo Bove2,
  4. Pauline Van Ouytsel1,
  5. Guido Costamagna2,
  6. Marc A Barthet3,
  7. Jacques Devière1
  1. 1Department of Gastroenterology, Hepatopancreatology and Digestive Oncology. Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, Belgium
  2. 2Digestive Endoscopy Unit, Digestive Endoscopy Unit. Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
  3. 3Gastroenterology, Hopital Nord, Marseille, France
  1. Correspondence to Dr Vincent Huberty, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology. Erasme Hospital, Université Libre de Bruxelles, Bruxelles 1070, Belgium; Vincent.Huberty{at}erasme.ulb.ac.be

Abstract

Objective Endoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).

Design Eligible patients (body mass index 30–40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.

Results Of the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.

Conclusions This study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.

Trial registration number NCT03255005.

  • therapeutic endoscopy
  • obesity
  • clinical trials
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Footnotes

  • MAB and JD are joint senior authors.

  • Twitter @ivoboskoski

  • Collaborators Hassane Njimi; Sandy Field

  • Contributors VH: writing the protocol, conducting the study, data analysis and interpretation, writing the manuscript, reviewing the manuscript IB: writing the protocol, conducting the study, writing the manuscript VB: conducting the study, data collection, critical revision of the manuscript. PVO: conducting the study, data collection and analysis, writing and critical revision of the manuscript. GC: critical revision of the manuscript. MAB: writing the protocol, conducting the study, data analysis and interpretation, writing the manuscript, critical revision of the manuscript. JD: writing the protocol, conducting the study, data analysis and interpretation, writing the manuscript, critical revision of the manuscript.

  • Funding This study is an academic study conducted in two centers. Endo Tools Therapeutics SA provided the instruments free of charge and a grant covering data management expenses to each center. Vincent Huberty and Jacques Deviere are shareholders of Endo Tools Therapeutics SA, which was initially a start-up of the Université Libre de Bruxelles where they are appointed.

  • Competing interests This study is an academic study conducted in two centers. Endo Tools Therapeutics SA provided the instruments free of charge and a grant covering data management expenses to each center. Vincent Huberty and Jacques Deviere are shareholders of Endo Tools Therapeutics SA, which was initially a start-up of the Université Libre de Bruxelles where they are appointed.

  • Patient consent for publication Not required.

  • Ethics approval The protocol was approved by the Ethics Committees at each institution.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request. Full anonymised database is available on request for meta-analysis or comparison trials. ICF, protocol and SAP are available on request.The request should be asked at vincent.huberty@erasme.ulb.ac.be.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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