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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02773589

Enrollment

Registered

2016-05-16

Start date

2014-03-31

Completion date

2017-04-30

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Achalasia

Brief summary

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.

Interventions

PROCEDUREPeroral endoscopic myotomy

Peroral endoscopic myotomy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The safety assessment will be based on the reading of all surgical intraoperative complications	6 months post surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026