Status:
UNKNOWN
POEM: Long vs Short Myotomy for Achalasia. RCT
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Achalasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Per-Oral Endoscopic Myotomy (POEM) is increasingly used for the treatment of achalasia. In published series, a 12cm-POEM is usually performed. Surgical myotomy is typically shorter (8cm). The clinical...
Detailed Description
Peroral Endoscopic Myotomy myotomy (POEM) has been recently introduced for treatment of achalasia, based on technical developments from NOTES (natural orifice translumenal surgery). The technique incl...
Eligibility Criteria
Inclusion
- Diagnosis of achalasia (type I and II)
- Age \> 18
- Signed informed consent
- Patient accepts to undergo scheduled follow-up after POEM
- Eckardt score \> 3
- ASA I-II-III
Exclusion
- Prior surgical treatment of achalasia (previous endoscopic balloon dilation or botox injection ARE NOT exclusion criteria)
- Pregnancy or nursing
- Current alcohol or drug addiction.
- Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator make the subject a poor candidate for this study.
- Severe congenital or acquired coagulopathy or INR \> 1.6
- Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
- Hepatic cirrhosis w/ or w/o portal hypertension w/ or w/o esophageal varices
- Eosinophilic esophagitis or Barrett Esophagus
- Esophageal Strictures
Key Trial Info
Start Date :
June 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03450928
Start Date
June 6 2014
End Date
January 1 2022
Last Update
March 1 2018
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli
Roma, RM, Italy, 00168