Esophagus Achalasia Clinical Trial
Official title:
Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach
| Verified date | May 2016 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | April 2017 |
| Est. primary completion date | April 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital, Strasbourg, france | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The safety assessment will be based on the reading of all surgical intraoperative complications | 6 months post surgery |