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OpenTrials
Completed

NCT Number: NCT06044155

redoPOEM : Failure of a First POEM

observational study, measurement of efficacy in the cohort.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Bordeaux, Bordeaux, France

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About this study

Achalasia is a motor disorder of the esophagus with a prevalence of 1/10000. Multiple treatments have been proposed, including endoscopic dilation, botulinum toxin injection and surgery using the Heller myotomy technique. These techniques are moderately effective and/or carry the risk of per- and post-procedural complications. POEM has been available since 2008, with 80-90% efficacy and 90% safety, and no serious complications have been reported. In the event of failure of a first POEM, a second POEM, known as "redoPOEM", can be proposed. Several studies show efficacy of between 76% and 96% and a safety of between 80% and 86%, with only one serious adverse event reported, and no deaths. However, the studies carried out involved small numbers of patients, generally around 50, the vast majority in Asian countries. The aim of this study was therefore to evaluate the efficacy and safety of redoPOEM reported in patients from several expert centers in Europe.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patient
  • diagnosis of achalasia based on clinical criteria according to Eckardt score, manometry, and radiology when available.
  • failure after POEM (Eckardt score > or equal to 4 in consultation) treated with a new POEM.
  • no active digestive neoplasia.

Exclusion criteria

  • Technical failure of redoPOEM
  • Person not affiliated to a Social Security scheme
  • Language barrier preventing fair collection of non-opposition.

Treatment and study plan

Primary outcomes

  1. Efficacy : score of Eckardt

    Time frame: 3 months after redoPOEM

    Evaluation of Eckardt score at 3 months after redoPOEM strictly less than 4. Each question is rated from 0 to 3. It consists of 4 items with a total score varies from 0 to 12.

Secondary outcomes

  1. Safety : Number of adverse events of grade II

    Time frame: Through study completion, an average of 1 year

    Evaluation of absence of adverse events of grade II or higher according to AGREE classification.

  2. Efficacy : Number of Eckart score strictly below 4

    Time frame: Through study completion, an average of 1 year

    Evaluation of Eckardt score strictly below 4 at last known follow-up after redoPOEM. Each question is rated from 0 to 3. It consists of 4 items with a total score varies from 0 to 12.

  3. Efficacy : Number of new additional procedure

    Time frame: Through study completion, an average of 1 year

    Evaluation of number of an additional procedure because of failure of redoPOEM.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Efficacy and Safety After Failure of a First POEM

Acronym: redoPOEM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Jul 10, 2024

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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