Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy
NCT05772260
Achalasia, Deglutition Disorders
Seoul, South Korea
View Trial DetailsNCT Number: NCT06044155
observational study, measurement of efficacy in the cohort.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Chu de Bordeaux, Bordeaux, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Through study completion, an average of 1 year
Evaluation of number of an additional procedure because of failure of redoPOEM.
University Hospital, Bordeaux
Other
Efficacy and Safety After Failure of a First POEM
Acronym: redoPOEM
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.
Published trials that share one or more normalized conditions with this study.
NCT05772260
Achalasia, Deglutition Disorders
Seoul, South Korea
View Trial DetailsNCT03063463
Achalasia, Deglutition Disorders
Nashville, Tennessee, United States
View Trial DetailsNCT01793922
Achalasia, Deglutition Disorders
Leuven, Belgium
View Trial DetailsNCT01512719
Achalasia, Deglutition Disorders
Jerusalem, Israel
View Trial Details