NCT06662370

Esophageal Replacement With a Decellularized Human Esophagus Graft

Remplacement de l'œsophage Par Une Greffe d'œsophage Humain décellularisé

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Stenosis

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2024-10-28
• Last updated: 2024-10-28