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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02259283
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, 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.


Condition or disease Intervention/treatment Phase
Achalasia Device: Hybrid Knife Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique
Study Start Date : December 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Achalasia
Patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will undergo POEM with the hybrid knife.
Device: Hybrid Knife
POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 24 months ]
    Percentage of patients with successful POEM

  2. Clinical Success [ Time Frame: 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 :
  1. Quality of Life [ Time Frame: 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.

  2. Adverse events [ Time Frame: 24 months ]
    Post-operative adverse events (perforation, bleeding, infection, aspiration, etc)

  3. Reflux disease [ Time Frame: 24 months ]
    Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry

  4. Treatment failure [ Time Frame: 24 months ]
    Percentages of patients in which other interventions for dysphagia are required after the first POEM.

  5. Efficacy [ Time Frame: 24 months ]
    Basal and post-treatment pressure of the lower esophageal sphincter, as measured by manometry and esophageal follow-through.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259283


Locations
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Italy
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Alessandro Repici, MD Istituto Clinico Humanitas
Publications:
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Responsible Party: Michele Tedeschi, Chief of Clinical research Project, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02259283    
Other Study ID Numbers: POEM-ICH
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: October 2014
Keywords provided by Michele Tedeschi, Istituto Clinico Humanitas:
achalasia
per oral endoscopic myotoymy
endoscopy
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases