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Esophageal Replacement With a Decellularized Human Esophagus Graft
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
The aim of the study is to analyze over a 12 month-period, the safety and the efficacy of a circumferentiel oesophageal replacement of the esophagus by a decelularized human esophagus, in 24 patient with a short esophageal stenosis refractory to endoscopic dilatations.
Official title: Remplacement de l'œsophage Par Une Greffe d'œsophage Humain décellularisé
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-11-01
Completion Date
2030-01-01
Last Updated
2024-10-28
Healthy Volunteers
No
Conditions
Interventions
Replacement of the esophagus with a decellularized human esophagus graft
The Decellularized Human Esophagus (DHE) will be surgically implanted under general anesthesia via right or left thoracotomy or cervicotomy, depending on the location of the stenosis, to replace the esophageal defect created by resection of the stenosis. An omentoplasty is performed laparoscopically beforehand to provide secondary coverage of the graft area. A temporary esophageal stent is placed endoscopically to cover the DHE and the two anastomoses for a period of 3 months, to prevent the development of an anastomotic fistula and stenosis of the graft area.