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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773589
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Esophagus Achalasia Procedure: Peroral endoscopic myotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Peroral endoscopic myotomy Procedure: Peroral endoscopic myotomy
Peroral endoscopic myotomy




Primary Outcome Measures :
  1. The safety assessment will be based on the reading of all surgical intraoperative complications [ Time Frame: 6 months post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773589


Locations
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France
University Hospital, Strasbourg, france
Strasbourg, France, 67000
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Silvana PERRETTA, MD University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02773589    
Other Study ID Numbers: 5368
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases