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Enrolling by invitation NCT05725967

Endoscopic Metabolic and Bariatric Therapies

— Observational Obesity Obesity, Morbid Obesity Associated Disorder Bariatric Surgery Candidate

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: Primary Obesity Endoscopic Procedures, Endoscopic Revision of Bariatric Surgical Procedures, Bariatric Surgery Procedures, Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction.
Who it may be relevant to
Registry conditions: Obesity, Obesity, Morbid, Obesity Associated Disorder, Bariatric Surgery Candidate. Basic parameters: 18 years — 80 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
United States
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

This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

Detailed description

The Investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.

Interventions

  • Procedure Primary Obesity Endoscopic Procedures
    Any primary endoscopic procedure for treatment of obesity including endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), Aspiration therapy, pylorus sparing antral myotomy (PSAM), primary obesity surgery endoluminal (POSE), gastroplasty with endoscopic myotomy (GEM).
  • Procedure Endoscopic Revision of Bariatric Surgical Procedures
    Any endoscopic revision procedure in a post-bariatric surgical patient, including transoral outlet reduction (TORe), restorative obesity surgery endoluminal (ROSE), argon plasma coagulation of the outlet (APC), endoscopic suturing.
  • Procedure Bariatric Surgery Procedures
    Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)
  • Device Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction
    Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.
  • Device Intragastric Balloon
    An endoscopic bariatric procedure involving the placement of an intragastric balloon.
  • Device Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal
    Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.
  • Device Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy
    Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.
  • Device Aspiration Therapy
    Placement of an aspiration therapy device for the treatment of obesity.

Primary outcome measures

  • Change in weight from pre-procedure to 10 years [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in hypertension from pre-procedure to 10 years using blood pressure measurements [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in hypertension from pre-procedure to 10 years using medication dosages [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
Secondary outcome measures (5)
  • Change in gastric motility from baseline to 10 years [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in PYY gut hormones from baseline to 10 years [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in GLP1 gut hormones from baseline to 10 years [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Change in ghrelin hormones from baseline to 10 years [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.]
  • Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years [Time frame: Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery]

Eligibility criteria

Inclusion criteria

  • patients from Mass General Brigham
  • any patient having an endoscopic primary obesity procedure
  • any patient having an endoscopic post-bariatric surgical revision procedure
  • any patient having a bariatric surgical procedure

Exclusion criteria

  • patients without past surgical and medical history medical records in the Mass General Brigham system
  • patients unwilling to allow for medical record review at Mass General Brigham

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

United States · 1 center
  • Brigham and Women's Hospital — Boston

Publications

  • 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. Ep PMID 35908555
  • Jirapinyo P, Thompson CC. Endoscopic gastric plication for the treatment of weight regain after Roux-en-Y gastric bypass (with video). Gastrointest Endosc. 2022 Jul;96(1):51-56. doi: 10.1016/j.gie.2022.02.051. Epub 2022 Mar 5. PMID 35259393
  • de Moura DTH, Hirsch BS, Boghossian MB, de Medeiros FS, McCarty TR, Thompson CC, de Moura EGH. Low-cost modified endoscopic vacuum therapy using a triple-lumen tube allows nutrition and drainage for treatment of an early post-bariatric surgery leak. Endoscopy. 2022 Jul;54(7):E376-E377. doi: 10.1055/a-1540-5870. Epub 2021 Aug 9. No abstract available. PMID 34374043
  • de Moura DTH, de Freitas Junior JR, de Souza GMV, de Oliveira GHP, McCarty TR, Thompson CC, de Moura EGH. Endoscopic management of acute leak after sleeve gastrectomy: principles and techniques. Endoscopy. 2022 Jul;54(7):E327-E328. doi: 10.1055/a-1525-1661. Epub 2021 Jul 9. No abstract available. PMID 34243196
  • Sanchez-Luna SA, Thompson CC, De Moura EGH, de Medeiros FS, De Moura DTH. Modified endoscopic vacuum therapy: Are we ready for prime time? Gastrointest Endosc. 2022 Jun;95(6):1281-1282. doi: 10.1016/j.gie.2021.12.049. No abstract available. PMID 35589208
  • Bazarbashi AN, Dolan RD, McCarty TR, Jirapinyo P, Thompson CC. Endoscopic revision of gastrojejunal anastomosis for the treatment of dumping syndrome in patients with Roux-en-Y gastric bypass: a systematic review and meta-analysis. Surg Endosc. 2022 Jun;36(6):4099-4107. doi: 10.1007/s00464-021-08731-4. Epub 2021 Oct 20. PMID 34669046
  • Jirapinyo P, Thompson CC. Primary Bariatric Procedures. Dig Dis Sci. 2022 May;67(5):1674-1687. doi: 10.1007/s10620-022-07393-z. Epub 2022 Mar 29. PMID 35348970
  • Argueta PP, Salazar M, Vargo JJ, Chahal P, Rodriguez JJ, Simons-Linares CR, Thompson CC. Thirty-Day Readmission After Bariatric Surgery: Causes, Effects on Outcomes, and Predictors. Dig Dis Sci. 2022 Mar;67(3):834-843. doi: 10.1007/s10620-021-06934-2. Epub 2021 Jun 24. PMID 34169433

Identifiers

NCT: NCT05725967 · 2022P001757

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗