Endoscopic Metabolic and Bariatric Therapies

• Conditions: Obesity; Complication of Treatment; Bariatric Surgery Candidate; Fistula, Gastric; Roux-en-y Anastomosis Site; Complication of Surgical Procedure; Weight Gain; Obesity Associated Disorder; Abdominal Pain; Weight Loss

• Registration Number: NCT05725967
• Lead Sponsor: Christopher C. Thompson, MD, MSc

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.

Study Timeline

• Study Start: 2022-07-08
• Study First Submitted: 2022-12-29
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Primary Completion: 2026-07-08
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change of HgA1c (%) by comparing lab values from baseline through 10 years.
Change in hypertension from pre-procedure to 10 years using medication dosages	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.
Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years.
Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.
Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.
Change in comorbidity medication dosages from baseline to 10 years	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change of dosage of comorbidity medications compared to baseline
Change in weight from pre-procedure to 10 years	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	%TBWL
Change in hypertension from pre-procedure to 10 years using blood pressure measurements	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.
Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline.
Change in rate of adverse events from procedure to 10 years	Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change in rate of adverse events post-procedure through 10 years
Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change in LDL measurements by comparing followup lab values (mg/dL) to baseline.
Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change in HDL measurements by comparing followup lab values (mg/dL) to baseline.
Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.	Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

Secondary Outcome Measures

Name	Time	Method
Change in gastric motility from baseline to 10 years	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.	Gastric emptying breath test
Change in GLP1 gut hormones from baseline to 10 years	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.	GLP1 lab values will be compared to baseline
Change in ghrelin hormones from baseline to 10 years	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.	Ghrelin lab values will be compared to baseline
Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years	Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery	Cost-effectiveness analysis of procedure costs from admission to discharge for endoscopic vs. surgical bariatric procedures
Change in PYY gut hormones from baseline to 10 years	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.	PYY lab values will be compared to baseline

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States