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

Phase 2

Completed

• Conditions: Achalasia
• Interventions: Device: Hybrid Knife

• Registration Number: NCT02259283
• Lead Sponsor: Istituto Clinico Humanitas

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 Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Study First Submitted: 2014-09-29
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-03
• Last Update Submitted: 2014-10-03
• Study First Posted: 2014-10-08
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Achalasia	Hybrid Knife	Patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will undergo POEM with the hybrid knife.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Adverse events	24 months	Post-operative adverse events (perforation, bleeding, infection, aspiration, etc)
Reflux disease	24 months	Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry
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.

Trial Locations

Locations (1)

Endoscopy Unit, Humanitas Research Hospital; 🇮🇹 Rozzano, Milano, Italy