Clinical Trial: Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique

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.

Detailed Summary:
Sponsor: Istituto Clinico Humanitas

Current Primary Outcome:

• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.

Original Secondary Outcome: Same as current

Information By: Istituto Clinico Humanitas

Dates:
Date Received: September 29, 2014
Date Started: December 2012
Date Completion:
Last Updated: October 3, 2014
Last Verified: October 2014