EGPSS for Weight Management in an in Vivo Human Model

Официальное название

A Novel Endoscopic Gastric Purse-string Suture Device for Weight Management in an in Vivo Human Model

Обзор

ndoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management. Mucosal ablation of the gastric fundus has been reported to limit fundic expansion and promote satiety; however, ablation can cause perforation, infection, bleeding, and other complications. To restrain fundic expansion while minimizing surgical trauma and preserving reversibility, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce gastric volume. This procedure may be suitable for short-term weight management. Safety and feasibility were demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

Подробное описание

The global prevalence of obesity has increased over the past five decades. Endoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management and have emerged as promising alternatives for treating obesity and related metabolic disorders (including type 2 diabetes and nonalcoholic fatty liver disease). Christopher et al. reported that ablation of the gastric fundus mucosa induces mucosal fibrosis; the resulting fibrotic tissue impedes fundic expansion and promotes satiety. However, fundic mucosal ablation may cause extensive and irreversible injury, increasing the risks of perforation, infection, bleeding, and other complications. A minimally invasive endoscopic therapy that inhibits fundic expansion while minimizing surgical trauma and preserving reversibility is therefore desirable.

Based on this rationale, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce the volume of the gastric fundus. EGPSS employs a specially designed endoclip in combination with an endoloop to appose the fundic mucosa and restrict fundic expansion. This procedure may be suitable for short-term weight management. Safety and feasibility have been demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

Вмешательства

• Процедура endoscopic gastric purse-string suturing
  A dual-tail endoloop will be introduced into the stomach with endoscopic forceps, and will be secured to the gastric wall using endoscopic clips. An endoscope hook was used to tighten both tails of the endoloop until all the clips converged.

Первичные конечные точки

• Percent Total Weight Loss (%TWL) measured by calibrated digital scale [Срок оценки: Baseline and 3 months post-procedure]

Вторичные конечные точки (6)

• Percent Excess Weight Loss (%EWL) measured by calibrated digital scale [Срок оценки: Baseline and 3 months]
• Satiety score (100-mm Visual Analog Scale, VAS) after standardized liquid meal [Срок оценки: Baseline and 3 months]
• Gastric fundus volume (magnetic resonance imaging, MRI) [Срок оценки: Baseline and 3 months]
• Fasting plasma ghrelin and leptin (ELISA) [Срок оценки: Baseline and 3 months]
• Insulin resistance (HOMA-IR) [Срок оценки: Baseline and 3 months]
• Procedure-related adverse events (ASGE lexicon severity grading) [Срок оценки: Day 0 to Month 3]

Критерии участия

Критерии включения

• Patients with a body mass index (BMI) of 24-35 kg / m²;
• Patients accepted Lifestyle modifications, pharmacological interventions for weight loss which were unsuccessful or experienced a weight rebound;
• Patients willing to loss weight;
• Obese patients with metabolic disorders.

Критерии исключения

• Women who are planning to conceive, pregnant, or breastfeeding;
• Patients who are suffering from severe organ failure requiring hospitalization;
• Patients who have undergone gastrectomy;
• Patients allergic to anesthetics.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The fifth Medical Center of Chinese PLA General Hospital — Пекин

Публикации

• Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8. PMID 30814686
• Maselli DB, Donnangelo LL, Coan B, McGowan CE. How to establish an endoscopic bariatric practice. World J Gastrointest Endosc. 2024 Apr 16;16(4):178-186. doi: 10.4253/wjge.v16.i4.178. PMID 38680199
• Simons M, Sharaiha RZ. Updates in metabolic bariatric endoscopy. Dig Endosc. 2024 Feb;36(2):107-115. doi: 10.1111/den.14633. Epub 2023 Aug 9. PMID 37405807
• Vargas EJ, Rizk M, Gomez-Villa J, Edwards PK, Jaruvongvanich V, Storm AC, Acosta A, Lake D, Fidler J, Bharucha AE, Camilleri M, Abu Dayyeh BK. Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study. Gut. 2023 Jun;72(6):1073-1080. doi: 10.1136/gutjnl-2022-327816. Epub 2022 Oct 14. PMID 36241388

Идентификаторы

NCT: NCT07186959 · EGPSS for weight management

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗