Manufacture of a valve against reflux by endoscopy, in patients who treated megaesophagus by endoscopy

Not Applicable

• Conditions: Achalasia; K21.0

• Registration Number: RBR-5r2rz6c
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-06
• Study Completion: 2021-12-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of endoscopic fundoplication therapy using the EsophyX Z device in patients with achalasia undergoing peroral endoscopic myotomy and who progressed with gastroesophageal reflux disease, following all 10 patients for a period of 12 months. It is expected to find lesser intensity of erosive esophagitis. Quantitative variables will be described using the mean, standard deviation, median and quartiles, and the pre and post fundoplication status will be compared using the t-Student or Mann-Whitney tests. Qualitative variables will be described using absolute and relative frequencies. A significance level of 5% will be used. We will use the SPSS statistical program for statistical analysis

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of endoscopic fundoplication therapy using the EsophyX Z device in patients with achalasia undergoing peroral endoscopic myotomy and who progressed with gastroesophageal reflux disease, following all 10 patients for a period of 12 months. It is expected to find less dependence on the use of proton pump inhibitors. Quantitative variables will be described using the mean, standard deviation, median and quartiles, and the pre and post fundoplication status will be compared using the t-Student or Mann-Whitney tests. Qualitative variables will be described using absolute and relative frequencies. A significance level of 5% will be used. We will use the SPSS statistical program for statistical analysis.