Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach

Achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical technique allowing to cure this pathology. In this study, investigators are using a new endoluminal technique of myotomy, innovative and less invasive, called POEM (PerOral Endoscopic Myotomy). This technique does not require any cutaneous incision.

Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated by the accession of natural orifice transluminal endoscopic surgery (NOTES). In this context, the introduction of the POEM technique seems to be an original approach and a natural evolution to a new generation of surgical endoscopy.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Esophagus achalasia
Confirmed by esophageal manometry
Requiring surgical care
No contraindication to general anesthesia
BMI under 40 kg/m²
Ability to give an informed consent
Candidate to elective Heller's myotomy
Affiliation to a social security system
Signed and informed consent

Exclusion criteria

Advanced esophageal dilatation (sigmoid megaesophagus)
Previous mediastinal or esophageal surgery
Contraindication to esophagogastroduodenoscopy (EGD)
Contraindication to general anesthesia
BMI above 40 kg/m²
Infectious esophagitis (e.g. candidiasis)
Psychiatric context unsuitable with an experimental protocol
Allergy to beta-lactam
Contraindication to endoscopy (esophageal stenosis, suspicion of digestive perforation, state of shock, severe anemia, cardiorespiratory failure or severe metabolic disorders)
Contraindication to monitored pneumoperitoneum (cardiorespiratory failure or severe metabolic disorders)
Inability to give an informed consent (emergency situations, misunderstanding…)
Patient in custody
Patient under guardianship
Pregnancy or breastfeeding

Treatment and study plan

Peroral endoscopic myotomy

Procedure

Peroral endoscopic myotomy

Primary outcomes

The safety assessment will be based on the reading of all surgical intraoperative complications

Time frame: 6 months post surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: May 16, 2016
Registry last updated: Jul 2, 2017

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.

Completed