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Recruiting NCT03554902

Endoscopic Gastric Tubulization

— Observational Morbid Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic gastric tubulization.
Who it may be relevant to
Registry conditions: Morbid Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016. The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

Detailed description

Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Despite its advantages (long term weight loss, comorbidities related to obesity improvement…), bariatric surgery is risky. In fact, complications putting the patient into a life-threatening condition can occur. Endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care.

Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications.

One of the major benefit of this technique is its reversibility. A new surgical or endoscopic procedure is possible at a later stage.

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

Interventions

  • Procedure Endoscopic gastric tubulization
    Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).

Primary outcome measures

  • Change in weight loss [Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure]
  • Change in excess weight loss [Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure]
  • Change in body mass index variation [Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure]
Secondary outcome measures (9)
  • Number of patients with procedure-related adverse event [Time frame: 7 days, 1 - 3 - 6 - 9 and 12 months after procedure]
  • Comorbidities improvement [Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure]
  • Quality of life improvement [Time frame: 3 - 12 - 18 and 24 months after procedure]
  • Gastro-intestinal quality of life improvement [Time frame: 3 - 12 - 18 and 24 months after procedure]
  • Modification in the feeling of satiety [Time frame: 1 - 3 - 6 - 12 - 18 and 24 months after procedure]
  • Upper GI tract radiologic evaluation [Time frame: 1 day, 6 - 12 and 24 months after procedure]
  • Upper GI tract endoscopic evaluation [Time frame: 6 - 12 and 24 months after procedure]
  • Procedure duration [Time frame: At time of procedure]
  • Number of stitches in place [Time frame: At time of procedure]

Eligibility criteria

Inclusion criteria

  • Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil — Strasbourg

Publications

  • Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7. PMID 25380508
  • Lopez-Nava G, Galvao MP, Bautista-Castano I, Jimenez-Banos A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7. PMID 26003549
  • Lopez-Nava G, Galvao M, Bautista-Castano I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15. PMID 26878054
  • Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7. PMID 25380510
  • Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24. PMID 23711556

Identifiers

NCT: NCT03554902 · 16-001-OBS (CPP) · 2017-A03599-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗