Endoscopic Gastric Tubulization

Morbid Obesity Clinical Trial

— Endosleeve  

Official title:

Endoscopic Gastric Tubulization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03554902
• Other study ID #: 16-001-OBS (CPP)
• Secondary ID: 2017-A03599-44
• Status: Recruiting
• Start date: June 8, 2018
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: IHU Strasbourg
• Contact: Silvana Perretta, MD, PhD
• Phone: + 33 3 69 55 05 31
• Email: silvana.perretta[@]ircad.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight loss	Change in weight loss measured in kilograms.	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Primary	Change in excess weight loss	Change in excess weight loss measured in percentage. Excess weight loss = (weight loss at time point / weight loss goal to reach a body mass index of 25 kg/m²) x 100	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Primary	Change in body mass index variation	Change in body mass index variation measured in kg/m².	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Secondary	Number of patients with procedure-related adverse event	Number of patients with procedure-related adverse event within 12 months after procedure.	7 days, 1 - 3 - 6 - 9 and 12 months after procedure
Secondary	Comorbidities improvement	Improvement of sleep apnea, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Secondary	Quality of life improvement	Improvement of quality of life assessed by Moorehead-Ardelt Quality of Life questionnaire II. Score range from -3.0 to 3.0.; Score from -3.0 to -2.1: very poor quality of life; Score from -2.0 to -1.1: poor quality of life; Score from -1.0 to 1.0: fair quality of life; Score from 1.1 to 2.0: good quality of life; Score from 2.1 to 3.0: very good quality of life.	3 - 12 - 18 and 24 months after procedure
Secondary	Gastro-intestinal quality of life improvement	Improvement of quality of life assessed by the Gastro-Intestinal Quality of Life Index questionnaire. A global score > 125 is considered as normal.	3 - 12 - 18 and 24 months after procedure
Secondary	Modification in the feeling of satiety	Satiety assessed by Three Factors Eating Questionnaire - R18. Three dimensions are assessed. The higher the score is, the more important the dimension is.; Restrained eating: score from 6 to 24; Uncontrolled eating: score from 9 to 36; Emotional eating: score from 3 to 12.	1 - 3 - 6 - 12 - 18 and 24 months after procedure
Secondary	Upper GI tract radiologic evaluation	Upper GI control series.	1 day, 6 - 12 and 24 months after procedure
Secondary	Upper GI tract endoscopic evaluation	Upper GI control gastroscopy.	6 - 12 and 24 months after procedure
Secondary	Procedure duration	Time required to perform the endoscopic gastric tubulization.	At time of procedure
Secondary	Number of stitches in place	Number of stitches put in place during the endoscopic gastric tubulization.	At time of procedure