Esophageal Replacement With a Decellularized Human Esophagus Graft

NCT ID: NCT06662370

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2030-01-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Esophagus replacement

Group Type: EXPERIMENTAL

Replacement of the esophagus with a decellularized human esophagus graft

Intervention Type: OTHER

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.

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pierre Cattan, MD PhD

Role: CONTACT

pierre.cattan@aphp.fr

+33142499116 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

+33142499742 ext. +33

Other Identifiers

APHP220793

Identifier Type: -

Identifier Source: org_study_id