Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia (POEM)
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|ClinicalTrials.gov Identifier: NCT02259283|
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : October 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Achalasia||Device: Hybrid Knife||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||September 2014|
Patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will undergo POEM with the hybrid knife.
Device: Hybrid Knife
POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.
- Feasibility [ Time Frame: 24 months ]Percentage of patients with successful POEM
- Clinical Success [ Time Frame: 24 months ]A reduction of 2 or more points in the Eckardt score, that determines a score of 3 or more in 24 months.
- Quality of Life [ Time Frame: 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.
- Adverse events [ Time Frame: 24 months ]Post-operative adverse events (perforation, bleeding, infection, aspiration, etc)
- Reflux disease [ Time Frame: 24 months ]Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry
- Treatment failure [ Time Frame: 24 months ]Percentages of patients in which other interventions for dysphagia are required after the first POEM.
- Efficacy [ Time Frame: 24 months ]Basal and post-treatment pressure of the lower esophageal sphincter, as measured by manometry and esophageal follow-through.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259283
|Endoscopy Unit, Humanitas Research Hospital|
|Rozzano, Milano, Italy, 20089|
|Principal Investigator:||Alessandro Repici, MD||Istituto Clinico Humanitas|