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

Primary Purpose

Esophagus Achalasia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Peroral endoscopic myotomy
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Achalasia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital, Strasbourg, france

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peroral endoscopic myotomy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2016
Last Updated
June 30, 2017
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02773589
Brief Title
Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach
Official Title
Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Achalasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peroral endoscopic myotomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Peroral endoscopic myotomy
Intervention Description
Peroral endoscopic myotomy
Primary Outcome Measure Information:
Title
The safety assessment will be based on the reading of all surgical intraoperative complications
Time Frame
6 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvana PERRETTA, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Strasbourg, france
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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