Clinical trial NCT02259283: Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia
Official title: Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Achalasia
Keywords: achalasia
per oral endoscopic myotoymy
endoscopy
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: 24 months
measure: Clinical Success
timeFrame: 24 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 24 months
measure: Adverse events
timeFrame: 24 months
measure: Reflux disease
timeFrame: 24 months
measure: Treatment failure
timeFrame: 24 months
measure: Efficacy
timeFrame: 24 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Alessandro Repici, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology. 1992 Dec;103(6):1732-8. doi: 10.1016/0016-5085(92)91428-7.
citation: Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
citation: Swanstrom LL, Kurian A, Dunst CM, Sharata A, Bhayani N, Rieder E. Long-term outcomes of an endoscopic myotomy for achalasia: the POEM procedure. Ann Surg. 2012 Oct;256(4):659-67. doi: 10.1097/SLA.0b013e31826b5212.