Endoscopic Metabolic and Bariatric Therapies

Obesity Clinical Trial

— EMBTs  

Official title:

Endoscopic Metabolic and Bariatric Therapies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05725967
• Other study ID #: 2022P001757
• Status: Enrolling by invitation
• Start date: July 8, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: July 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Obesity
• Abdominal Pain
• Anastomotic Leak
• Bariatric Surgery Candidate
• Body Weight
• Complication of Surgical Procedure
• Complication of Treatment
• Complication,Postoperative
• Fistula
• Fistula, Gastric
• Gastric Fistula
• Gastroparesis
• Leak, Anastomotic
• Obesity
• Obesity Associated Disorder
• Obesity, Abdominal
• Obesity, Morbid
• Postoperative Complications
• Roux-en-y Anastomosis Site
• Stomach Ulcer
• Ulcer, Gastric
• Weight Gain
• Weight Loss

Intervention

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).
• 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.
• 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.
• Intragastric Balloon
An endoscopic bariatric procedure involving the placement of an intragastric balloon.
• 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.
• 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.
• Aspiration Therapy
Placement of an aspiration therapy device for the treatment of obesity.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Christopher C. Thompson, MD, MSc

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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 Au — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight from pre-procedure to 10 years	%TBWL	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in hypertension from pre-procedure to 10 years	Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in hypertension from pre-procedure to 10 years	Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years	Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years	Change of HgA1c (%) by comparing lab values from baseline through 10 years.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years	Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years	Change in LDL measurements by comparing followup lab values (mg/dL) to baseline.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years	Change in HDL measurements by comparing followup lab values (mg/dL) to baseline.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years	Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years	Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years	Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.	Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in rate of adverse events from procedure to 10 years	Change in rate of adverse events post-procedure through 10 years	Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Primary	Change in comorbidity medication dosages from baseline to 10 years	Change of dosage of comorbidity medications compared to baseline	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Secondary	Change in gastric motility from baseline to 10 years	Gastric emptying breath test	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Secondary	Change in PYY gut hormones from baseline to 10 years	PYY lab values will be compared to baseline	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Secondary	Change in GLP1 gut hormones from baseline to 10 years	GLP1 lab values will be compared to baseline	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Secondary	Change in ghrelin hormones from baseline to 10 years	Ghrelin lab values will be compared to baseline	Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Secondary	Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years	Cost-effectiveness analysis of procedure costs from admission to discharge for endoscopic vs. surgical bariatric procedures	Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery