EMBTs: Endoscopic Metabolic and Bariatric Therapies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Primary Obesity Endoscopic Procedures Primary endoscopic procedures for treatment of obesity. |
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).
Other Names:
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.
Other Names:
Device: Intragastric Balloon
An endoscopic bariatric procedure involving the placement of an intragastric balloon.
Other Names:
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.
Other Names:
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.
Other Names:
Device: Aspiration Therapy
Placement of an aspiration therapy device for the treatment of obesity.
Other Names:
|
| Endoscopic Revision of Bariatric Surgical Procedures Endoscopic revision of post-bariatric surgical complications. |
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
| Bariatric Surgery Procedures Bariatric surgical procedures. |
Procedure: Bariatric Surgery Procedures
Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [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 hypertension from pre-procedure to 10 years [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 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 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 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 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 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.
- 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 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 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
Secondary Outcome Measures
- 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 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
- 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
Eligibility Criteria
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:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Christopher C. Thompson, MD, MSc
Investigators
- Principal Investigator: Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
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. Epub 2022 Jul 28.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2022P001757