Esophageal Replacement With a Decellularized Human Esophagus Graft (ESOGRAFT)

Assistance Publique - Hôpitaux de Paris

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Esophageal Stenosis

Treatments: Other: Replacement of the esophagus with a decellularized human esophagus graft

Study type: Interventional

Funder types: Other

Identifiers

NCT06662370

APHP220793

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 to 65
• Caustic, traumatic, anastomotic, post-operative, radiation-induced or post-endoscopic (mucosal resection, submucosal dissection) benign esophageal stricture refractory to endoscopic dilatation.
• For women: effective contraception for the entire duration of the study (from signature of consent to end of follow-up)
• Affiliated or beneficiary of a social security scheme.
• Free written consent signed by the participant and the investigator.

Exclusion criteria

• Weight loss > 10% of body weight over last 3 months
• Stenosis > 5 cm in length
• Multiple strictures
• Esophageal mouth stenosis
• Anterior surgery close to the operative zone
• Complete anterior omentectomy
• Tumour stenosis or progressive tumour pathology
• Non-stabilized psychiatric disorders
• Participation in another interventional study
• Pregnant or breast-feeding women
• Women of childbearing age without effective contraceptive measures:

All women of childbearing age must have a negative pregnancy test prior to treatment and must agree to maintain highly effective contraception using contraceptive measures from the date of consent until 12 months due to the risks associated with anesthesia during endoscopy

• Uncontrolled sepsis

• Related to the transplant procedure

  • ASA score ≥ 3,
  • Severe respiratory insufficiency (FEV1 < 1 L),
  • Decompensated hepatic cirrhosis or presence of esophageal varices,
  • Chronic renal insufficiency (creatinine > 1.25 N),
  • Myocardial infarction less than 6 months old or progressive heart disease,
  • WHO general condition > 2,
  • Weight loss >20% not recovered after renutrition.

• Contraindication to general anaesthesia, analgesics and antibiotics.

• Conditions requiring long-term immunosuppressive or corticosteroid treatment.

• Patients under curatorship or guardianship

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Esophagus replacement

Experimental group

Treatment:

Other: Replacement of the esophagus with a decellularized human esophagus graft