Clinical trial NCT05725967: Endoscopic Metabolic and Bariatric Therapies
Official title: Endoscopic Metabolic and Bariatric Therapies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obesity
Obesity, Morbid
Obesity Associated Disorder
Bariatric Surgery Candidate
Fistula, Gastric
Roux-en-y Anastomosis Site
Ulcer, Gastric
Abdominal Pain
Abdominal Obesity
Complication of Surgical Procedure
Complication of Treatment
Complication,Postoperative
Weight Gain
Weight Loss
Leak, Anastomotic
Delayed Gastric Emptying Following Procedure
Keywords: 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
pylorus sparing antral myotomy (PSAM)
gastric emptying breath test (GEBT)
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients registered with Mass General Brigham affiliate facilities who have undergone an endoscopic primary obesity procedure, an endoscopic bariatric revision procedure, or a bariatric surgical procedure.

Brief summary: 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.

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

Primary outcomes:
measure: Change in weight from pre-procedure to 10 years
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in hypertension from pre-procedure to 10 years using blood pressure measurements
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in hypertension from pre-procedure to 10 years using medication dosages
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in rate of adverse events from procedure to 10 years
timeFrame: Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in comorbidity medication dosages from baseline to 10 years
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Secondary outcomes:
measure: Change in gastric motility from baseline to 10 years
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in PYY gut hormones from baseline to 10 years
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in GLP1 gut hormones from baseline to 10 years
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Change in ghrelin hormones from baseline to 10 years
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
measure: Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years
timeFrame: Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher C. Thompson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Jirapinyo P, McCarty TR, Dolan RD, Shah R, Thompson CC. Effect of Endoscopic Bariatric and Metabolic Therapies on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2022 Mar;20(3):511-524.e1. doi: 10.1016/j.cgh.2021.03.017. Epub 2021 Mar 13.
citation: Singh S, Bazarbashi AN, Khan A, Chowdhry M, Bilal M, de Moura DTH, Jirapinyo P, Thakkar S, Thompson CC. Primary obesity surgery endoluminal (POSE) for the treatment of obesity: a systematic review and meta-analysis. Surg Endosc. 2022 Jan;36(1):252-266. doi: 10.1007/s00464-020-08267-z. Epub 2021 Feb 1.
citation: Thompson CC, Jirapinyo P, Shah R, Simsek C. Gastroplasty With Endoscopic Myotomy (GEM) for the Treatment of Obesity: Preliminary Efficacy and Physiologic Results. Gastroenterology. 2022 Nov;163(5):1173-1175. doi: 10.1053/j.gastro.2022.07.077. Epub 2022 Aug 10. No abstract available.
citation: Jirapinyo P, Thompson CC. Comparison of distal primary obesity surgery endolumenal techniques for the treatment of obesity (with videos). Gastrointest Endosc. 2022 Sep;96(3):479-486. doi: 10.1016/j.gie.2022.04.1346. Epub 2022 May 11.