Transoral fundoplication without incision using the EsophyX Z ® device to control gastroesophageal reflux disease after peroral endoscopic myotomy (POEM), in patients with achalasia: a pilot study

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo0 个研究点开始时间: 2021年5月6日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Age greater than or equal to 18 years; Patients with an established diagnosis of achalasia (primary or secondary), confirmed by an esophageal manometry test and who has undergone endoscopic treatment (POEM) and subsequently evolved with GERD, confirmed through a 24-hour esophageal pH-metry examination, in addition to clinical symptoms (heartburn, regurgitation) with or without endoscopic findings of erosive esophagitis; 24h PHmetry (performed after POEM) showing pathological reflux (defined as the total% of time - acid exposure time, pH <4.0) is> 6% or a DeMeester score> 14.7, according to the one established in the Lyon Consensus20; The individual who agrees to participate in the study and signs the free and informed consent form

•Pregnancy; Body mass index (BMI) = 30 kg / m2; Hiatal hernia> 2 cm; Surgical myotomy with prior fundoplication; Persistent dysphagia, weight loss or oesophageal bleeding; Barrett's esophagus; Any active medical condition that prevents the study from being completed; Coagulopathy or chronic use of anticoagulants; Esophageal or gastric varices; esophageal ulcers; Delay in gastric emptying; Neoplasms, esophageal, gastric or duodenal strictures, or any other important anatomical alteration of the upper digestive tract that may make the procedure impossible; When you are not receiving anti-reflux medication, the base score of the GERD-HRQL form is less than or equal to 12

发起方

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo