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

June 30, 2017 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67000
        • University Hospital, Strasbourg, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peroral endoscopic myotomy
Procedure: Peroral endoscopic myotomy
Peroral endoscopic myotomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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