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

NCT02773589 | Completed

• 1 other identifier: 5368
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Achalasia

Outcome Measures

Primary Outcomes (1)

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

  6 months post surgery

Study Arms (1)

Peroral endoscopic myotomy

EXPERIMENTAL

Procedure: Peroral endoscopic myotomy

Interventions

Peroral endoscopic myotomy PROCEDURE

Peroral endoscopic myotomy

Peroral endoscopic myotomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Silvana PERRETTA, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 16, 2016
• Study Start: March 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)