Clinical trial NCT03406975: Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)
Official title: Multi-center ESG Randomized Interventional Trial (MERIT-Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypertension
Diabetes Mellitus, Type 2
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Texas
name: Johns Hopkins University
name: Brigham and Women's Hospital
name: Endeavor Health
name: University of Chicago
name: Orlando Health, Inc.
name: Cornell University
name: Avera McKennan Hospital & University Health Center
First posted: 2018-01-23
Enrollment: 208
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endoscopically placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction.

Up to 200 participants at 9 locations in the United States will participate in this study.

The ESG procedure has been performed clinically since 2013 in the United States. The investigators are completing this study to compare how effective the ESG is for achieving long-term weight loss when compared to lifestyle modification only, as well as to evaluate the long-term safety and durability of the procedure and its impact on quality of life. Results of this research may help support having this procedure covered by health insurance plans for future patients.


Eligibility criteria: INCLUSION CRITERIA

1. Age 21-65
2. BMI ≥ 30 and ≤40 kg/m²
3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
4. History of failure with non-surgical weight-loss methods
5. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits
7. Ability to give informed consent
8. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
9. \*\*\*There will be a quota for at least a) 50 patients with hypertension on one or more anti-hypertensive medication, b) 50 patients with type II diabetes mellitus on oral agents only with HgA1c ≤ 9, and thus the cohort of 200 patients will be stratified into three groups (Obesity, Obesity HTH, Obesity DM) and block randomized. No more than 50 participants without comorbidities will be enrolled in the trial.

EXCLUSION CRITERIA

1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
2. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
3. Prior open or laparoscopic bariatric surgery.
4. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
5. Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
6. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
7. A gastric mass or gastric polyps \> 1 cm in size.
8. A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
10. Achalasia or any other severe esophageal motility disorder
11. Severe coagulopathy.
12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C \>= 9.
13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
14. Chronic abdominal pain
15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
16. Hepatic insufficiency or cirrhosis
17. Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
18. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist
19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
20. Patients receiving daily prescribed treatment with high dose aspirin (\> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
22. Patients who are pregnant or breast-feeding.
23. Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly-controlled hypertension, required use of NSAIDs
24. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
25. Subjects who are taking corticosteroids, immunosuppressants, and narcotics
26. Subjects who are taking diet pills
27. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
28. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
29. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
30. Specific diagnosed genetic disorder such as Prader Willi syndrome.
31. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
32. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.

Primary outcomes:
measure: Percentage of Excess Weight Loss (EWL)
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With ≥25% EWL
timeFrame: 12 months
measure: Number of Participants Off Or With Reduction in Antihypertensive Medications
timeFrame: 12 months
measure: Change in Blood Pressure
timeFrame: Baseline, 12 months
measure: Change in Blood Pressure for ESG Intervention From Baseline to 24 Months
timeFrame: Baseline, 24 months
measure: Number of Participants Off or With Reduction in Diabetes Medications
timeFrame: 12 months
measure: Change in HgbA1c
timeFrame: Baseline, 12 months
measure: Change in HgbA1c for ESG Intervention From Baseline to 24 Months
timeFrame: Baseline, 24 months
measure: Percentage of Total Body Weight Loss (TBWL)
timeFrame: 12 months
measure: Number of Participants to Achieve ≥5% TBWL
timeFrame: 12 months
measure: Number of Participants to Achieve ≥10% TBWL
timeFrame: 12 months
measure: Esophagitis at Repeat Endoscopy
timeFrame: 12 months
measure: Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
timeFrame: Baseline, 12 months
measure: Changes in Health Status Survey Scores
timeFrame: Baseline, 12 months
measure: Number of Participants With Major Depression or Severe Major Depression at Baseline
timeFrame: Baseline
measure: Number of Participants With Major Depression or Severe Major Depression at 12 Months
timeFrame: 12 months
measure: Change in Eating Behaviors
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: New York
country: United States
facility: Cornell University
state: New York
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital & University Health Center
state: South Dakota
city: Houston
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Barham K Abu Dayyeh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vargas EJ, Rizk M, Gomez-Villa J, Edwards PK, Jaruvongvanich V, Storm AC, Acosta A, Lake D, Fidler J, Bharucha AE, Camilleri M, Abu Dayyeh BK. Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study. Gut. 2023 Jun;72(6):1073-1080. doi: 10.1136/gutjnl-2022-327816. Epub 2022 Oct 14.
citation: Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.