Obesity, Mild
Conditions
Keywords
obesity, endoscopic bariatric and metabolic therapy, bariatric surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREendoscopic 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.
Sponsors
Liu Yan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Total Weight Loss (%TWL) measured by calibrated digital scale | Baseline and 3 months post-procedure | Body weight recorded using a calibrated digital scale (kg). %TWL calculated as (baselineweight-follow-upweight)÷baselineweight × 100%. Measurements obtained under fasting conditions, light clothing, no shoes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety score (100-mm Visual Analog Scale, VAS) after standardized liquid meal | Baseline and 3 months | Satiety assessed using a 100-mm VAS (0 = not at all, 100 = extremely) at 0, 15, 30, 60 minutes after a 400-kcal standardized liquid meal; area under the curve (AUC) computed. |
| Gastric fundus volume (magnetic resonance imaging, MRI) | Baseline and 3 months | Fundic volume quantified by MRI volumetry during a standardized water-challenge protocol; primary read by a blinded radiologist; volume reported in mL and Δ from baseline. |
| Percent Excess Weight Loss (%EWL) measured by calibrated digital scale | Baseline and 3 months | %EWL calculated as (baselineweight-follow-upweight)÷(baselineweight-idealweightatBMI25kg/m ) × 100%. |
| Insulin resistance (HOMA-IR) | Baseline and 3 months | HOMA-IR calculated from fasting glucose (mmol/L) and insulin (µU/mL): insulin × glucose ÷ 22.5. |
| Procedure-related adverse events (ASGE lexicon severity grading) | Day 0 to Month 3 | All adverse events captured and coded using the ASGE lexicon with severity grade and relatedness adjudicated by the safety monitor. |
| Fasting plasma ghrelin and leptin (ELISA) | Baseline and 3 months | Morning fasting venous samples analyzed by validated ELISA; concentrations reported in pg/mL (ghrelin) and ng/mL (leptin). |
Countries
China
Outcome results
None listed