Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty: a Single-centre Open-label, Randomized, Controlled Pilot Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG)
研究概览
简要总结
The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:
- Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.
- Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).
The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 65 years
- •BMI between 30 to 45 kg/m2
- •Willingness to participate in the study and ability to comply and understand the study protocol.
排除标准
- •Active gastric gastro-duodenal during the last 6 months
- •Helicobacter pylori infection.
- •Organic or motility disorder of the stomach and / or esophagus
- •Anticoagulant treatment
- •Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
- •Ongoing or active malignancy during the last 5 years.
- •Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification.
- •Drug or alcohol abuse
- •Bulimic or binge eating pattern
- •Continuous glucocorticoid or anti-inflammatory treatment
- •Uncontrolled thyroid disease.
- •Pregnancy, breastfeeding
- •Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
- •Hiatal hernia ≥ 5 cm
- •Known allergy or hypersensitivity to the active substance or any of the other excipients
- •Liver cirrhosis of any Child-Phugh stage or MELD> 15
- •Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation)
- •Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
- •Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
研究组 & 干预措施
Arm A: experimental group
no administration of Esomeprazole or any other proton pump inhibitor after the Endoscopic Sleeve Gastroplasty
干预措施: Esomeprazole (Drug)
Arm B: standard of care group
administration of Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for another 4 weeks after the Endoscopic Sleeve Gastroplasty
干预措施: Esomeprazole (Drug)
结局指标
主要结局
The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG)
时间窗: 6 months
The structural integrity of the ESG will be defined as opened (all stitches loose), partially intact (at least one stitch loose), or intact (all stitches tight).
次要结局
未报告次要终点