Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is performed, and has advantage over surgery because it is performed endoscopically, thus is less invasive. One potential disadvantage in respect to surgery may be that it may determine higher rates of post-operative reflux. The purpose of this study is to prospectively assess the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3 and 12 months. This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will be included for the POEM procedure. This study will last about 2 years. The aim is the feasibility, security and success rate of POEM for achalasia. Patients will be followed for at least one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy
Feasibility
Percentage of patients with successful POEM
Time frame: 24 months
Clinical Success
A reduction of 2 or more points in the Eckardt score, that determines a score of 3 or more in 24 months.
Time frame: 24 months
Quality of Life
Quality of life as measured by questionnaires (SF36 and l'EORTC QLQ-OES24) that will be administered to the patients at 3 and 12 months.
Time frame: 24 months
Adverse events
Post-operative adverse events (perforation, bleeding, infection, aspiration, etc)
Time frame: 24 months
Reflux disease
Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry
Time frame: 24 months
Treatment failure
Percentages of patients in which other interventions for dysphagia are required after the first POEM.
Time frame: 24 months
Efficacy
Basal and post-treatment pressure of the lower esophageal sphincter, as measured by manometry and esophageal follow-through.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.