Endoscopic Metabolic and Bariatric Therapies

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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).
• Процедура 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.
• Процедура Bariatric Surgery Procedures
  Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)
• Устройство 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.
• Устройство Intragastric Balloon
  An endoscopic bariatric procedure involving the placement of an intragastric balloon.
• Устройство 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.
• Устройство 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.
• Устройство Aspiration Therapy
  Placement of an aspiration therapy device for the treatment of obesity.

Первичные конечные точки

• Change in weight from pre-procedure to 10 years [Срок оценки: 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 [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]
• Change in hypertension from pre-procedure to 10 years using medication dosages [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.]

Вторичные конечные точки (5)

• Change in gastric motility from baseline to 10 years [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.]
• Change in PYY gut hormones from baseline to 10 years [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.]
• Change in GLP1 gut hormones from baseline to 10 years [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.]
• Change in ghrelin hormones from baseline to 10 years [Срок оценки: 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 [Срок оценки: Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Публикации

• 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

Идентификаторы

NCT: NCT05725967 · 2022P001757

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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