Ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.
Obesity is one of the most prevalent diseases worldwide with a major impact on the health care system in many countries. Bariatric surgery is currently the first treatment option in obese patients because it offers lasting results on body weight loss and reduces disease-related comorbidities. In recent years, however, endoscopic sleeve gastroplasty (ESG) has emerged as a safe and effective method in treating obese patients. Considering the lower complication rate compared with bariatric surgery and the greater weight loss compared with medical therapy, ESG finds indication as a treatment in cases of class I and II obesity. In cases of BMI \> 40 or higher, bariatric surgery is actually the best option to achieve lasting weight loss but may be burdened by significant morbidity and mortality related to the surgery itself. Ghrelin is a potent oressigenic hormone produced and secreted mainly by the endocrine cells of the gastric glands at the bottom of the stomach and acts in the brain to regulate food intake. Gastric ghrelin plays a key role in glucose metabolism. Obese patients generally show reduced levels of ghrelin and a high percentage of these patients are insulin-resistant, have high circulating levels of insulin, hyperglycemia or diabetes. Through gene expression data and electron microscopy the activity of GPCs (ghrelin-like cells) could be increased in obese patients and correlates with glycemic levels. A positive correlation has been suggested between ghrelin gene expression, glycemic values and body mass index in obese patients. Taken together, these data indicate that ghrelin overproduction by the stomach may be involved in the weight gain and pathogenesis of type 2 diabetes in obese patients. This study aims to demonstrate how further ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. Indeed, HybridAPC could stimulate fundus stem cells to produce new ghrelin-secreting endocrine cells with normal secretory activity as in lean subjects. Thus normalizing ghrelin signaling to appetite/hunger areas in the brain relayed through the gut brain axis. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
All endoscopic procedures will be performed with the patient in the supine position, under general anesthesia, with endotracheal intubation, in CO2 using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a dual-channel endoscope (GIF-2TH180 or GIF-2TH160; Olympus, Center Valley, PA, USA ). The HybridAPC with submucosal injection and APC will be delivered by ErbeJet®2. ESG will be obtained by placing full-thickness sutures in the body gastric wall, from the angulus to the gastric fundus. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. In the next step HybridAPC to the gastric mucosa of the fundus is applied.
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy
RECRUITINGIncidence of Adverse Events
Safety, Tolerability and Efficacy of HybridAPC for gastric mucosa ablation of the fundus in patients undergoing endoscopic sleeve gastroplasty
Time frame: 18 months
HybridAPC
To assess the additional effect of gastric mucosa ablation in the fundus by HybridAPC upon ESG on total body weight (Kilograms) over time
Time frame: 18 months
Gastric Hormones
assess changes in plasma levels of gastric hormones. Fasting blood samples will be taken at baseline and 1, 6 and 12 months follow up visits and stored at -80℃ until assayed. Hormone measurement will be conducted using enzyme-linked immunosorbent assay (ELISA). Assay validation is performed by the manufacturer, testing the precision of the assay and its sensitivity. Ghrelin levels will be measured by ELISA (Lifespan Biosciences, Seattle, WA) with a sensitivity \< 0.094 ng/ml and an intra- and inter-assay precision \<10% and \<10%, respectively. Leptin levels will be measured by ELISA (Lifespan Biosciences, Seattle, WA) with a sensitivity \< 10 pg/ml and an intra- and inter-assay precision \<6.4% and \<7.4%, respectively. GLP-1 levels will be measured by ELISA (Lifespan Biosciences, Seattle, WA) with a sensitivity \< 0.31 ng/ml and an intra- and inter-assay precision \<9.09% and \<8.33%, respectively.
Time frame: 18 months
Life changes
assess quality of life changes at baseline and 1,6,12 months follow up using the BAROS, SF-36 and IWQOL-Lite-CT questionnaire.
Time frame: 18 months
Comorbidity
Comorbidity improvements after ESG and Hybrid APC: Hypertension improvement was considered upon reaching values of PA \< 130/80 mmHg or if antihypertensive therapy was discontinued while maintaining pressure values \<130/80 mmHg. Hyperinsulinemia improvement was considered if the achieved HOMA score was \< 1.8 at any time during follow-up after ESG. Type 2 diabetes mellitus (DMT2) improvement will be considered if the achieved fasting blood glucose will be on values \< 126 mg/dl in at least 2 different measurements or if the glycated hemoglobin value will be \< 6 % or if medical therapy will discontinue. Obstructive sleep apnea syndrome (OSAS) improvement will be considered if nocturnal pO2 \> 92% or if symptoms will disappear without the use of CPAP.
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Time frame: 18 months