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

NCT ID: NCT02773589

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peroral endoscopic myotomy

Group Type: EXPERIMENTAL

Peroral endoscopic myotomy

Intervention Type: PROCEDURE

Peroral endoscopic myotomy

Interventions

Peroral endoscopic myotomy

Peroral endoscopic myotomy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvana PERRETTA, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

University Hospital, Strasbourg, france

Strasbourg, , France

Countries

France

Other Identifiers

5368

Identifier Type: -

Identifier Source: org_study_id