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

Istituto Clinico Humanitas

Status and phase

Completed

Phase 2

Conditions

Achalasia

Treatments

Device: Hybrid Knife

Study type

Interventional

Funder types

Other

Identifiers

NCT02259283

POEM-ICH

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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