Status:
COMPLETED
Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Achalasia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 endosco...
Eligibility Criteria
Inclusion
- Age 18 to 75 years
- Manometric diagnosis of achalasia
- Eckardt score more than 3
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02259283
Start Date
December 1 2012
End Date
September 1 2014
Last Update
October 8 2014
Active Locations (1)
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1
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy, 20089