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NOT YET RECRUITING
NCT06662370
PHASE1/PHASE2

Esophageal Replacement With a Decellularized Human Esophagus Graft

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Interventions

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.