Achalasia
Conditions
Keywords
achalasia, per oral endoscopic myotoymy, endoscopy
Brief summary
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.
Interventions
DEVICEHybrid Knife
POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 75 years * Manometric diagnosis of achalasia * Eckardt score more than 3 * Informed consent
Exclusion criteria
* Increased surgical risk for important comorbidities, * Pseudoachalasia * Mega-esophagus (more than 7 cm) and or sigmoid esophagus, * Previous esophageal or gastric surgery (with the exception of gastric perforation) * Inability of completing the questionnarie * Inability to keep a commitment for follow-up * Esophageal diverticulum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 24 months | Percentage of patients with successful POEM |
| Clinical Success | 24 months | A reduction of 2 or more points in the Eckardt score, that determines a score of 3 or more in 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reflux disease | 24 months | Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry |
| Quality of Life | 24 months | 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. |
| Efficacy | 24 months | Basal and post-treatment pressure of the lower esophageal sphincter, as measured by manometry and esophageal follow-through. |
| Treatment failure | 24 months | Percentages of patients in which other interventions for dysphagia are required after the first POEM. |
| Adverse events | 24 months | Post-operative adverse events (perforation, bleeding, infection, aspiration, etc) |
Countries
Italy
Outcome results
None listed