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NCT Number: NCT02259283

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

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.

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hybrid knife

Device

POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique

Acronym: POEM

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2014
Registry last updated
Oct 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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