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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT02773589
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
37
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Peroral endoscopic myotomy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Apr 1, 2017
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peroral endoscopic myotomy

Procedure: Peroral endoscopic myotomy
Peroral endoscopic myotomy

Outcome Measures

Primary Outcome Measures

  1. The safety assessment will be based on the reading of all surgical intraoperative complications [6 months post surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital, Strasbourg, france Strasbourg France 67000

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Silvana PERRETTA, MD, University Hospital, Strasbourg, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02773589
Other Study ID Numbers:
  • 5368
First Posted:
May 16, 2016
Last Update Posted:
Jul 2, 2017
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Esophageal Achalasia

Study Results

No Results Posted as of Jul 2, 2017