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The goal of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects with the need of liver transplantation to reduce their BMI in order to enter the waiting list (BMI (≥35 kg/m2). The main question[s] it aims to answer are:
Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver transplant obese candidates | Experimental | Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic sleeve gastroplasty (ESG) | Procedure | ESG will be performed under general anaesthesia with orotracheal intubation. The Endomina® suturing system (EndoTools Therapeutics S.A., Gosselies, Belgium) mounted on a single channel endoscope will be used. This system allows to obtain full thickness gastric sutures through the gastric wall of the gastric body, leaving the antrum and the gastric fundus free15. The procedure will be performed with the patient in supine position. Carbon dioxide will be blown to stretch the gastric lumen. An initial endoscopic evaluation will be performed immediately to confirm the absence of any contraindication to ESG before suturing. The ESG starts with the reduction of the gastric body, suturing from distal to proximal and starting from the notch of the angulus and ending at the level of the fundus. 4-8 full thickness stitches will be placed, with 2 passes per stitch. |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant list inclusion | number of patients who achieve a BMI < 35 kg/m² within 12 months post-ESG, allowing them to be included in the transplant list | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Marrone | Contact | +390630157779 | giuseppe.marrone@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli IRCCS | Recruiting | Rome | Lazio | 00168 | Italy |
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|
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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