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

Not Applicable

Completed

• Conditions: Esophagus Achalasia
• Interventions: Procedure: Peroral endoscopic myotomy

• Registration Number: NCT02773589
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Status Verified: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-16
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peroral endoscopic myotomy	Peroral endoscopic myotomy	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital, Strasbourg, france; 🇫🇷 Strasbourg, France