Esophageal Replacement With a Decellularized Human Esophagus Graft

NCT06662370 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: APHP220793
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Keywords

Tissue engineering; Esophageal replacement; Esophageal stenosis; Caustic injury; Radiotherapy; Anastomotic stenosis; Esophageal stent

Outcome Measures

Primary Outcomes (2)

• Morbidity/mortality

  Safety criterion : morbidity/mortality defined by : Refractory stenosis, leaking, sepsis, stent migration, death, complete rupture of anastomoses, uncontrolled mediastinal sepsis requiring removal of the substitute and/or esophagectomy, delamination of the tissue graft, tracheobronchial wound intra-operatively or oesotracheal fistula postoperatively, upper digestive obstruction after stent removal preventing any attempt to dilate the graft zone, or upper digestive obstruction after stent removal preventing any attempt to dilate the graft zone

  At 3 months after surgery

• Nutritional autonomy

  Efficacy criterion: nutritional autonomy at 12 months after esophageal replacement defined as stable weight with exclusive oral nutrition and without esophageal stenting for at least 3 months, and without persistent symptomatic scar stenosis after 5 endoscopic dilatation sessions

  At 12 months after esophageal replacement

Secondary Outcomes (14)

• Safety of the procedure

  At 12 months after esophageal replacement

• Presence of complete re-epithelialization, and integration into the native esophagus

  At 3 months after surgery

• Presence of complete re-epithelialization, and integration into the native esophagus

  At 12 months after surgery

• Normal bolus transit

  At 6 months after surgery

• Normal bolus transit

  At 12 months after surgery

Study Arms (1)

Esophagus replacement

EXPERIMENTAL

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

Interventions

Replacement of the esophagus with a decellularized human esophagus graft 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.

Esophagus replacement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Pierre Cattan, MD PhD

CONTACT

+33142499116; pierre.cattan@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, non-comparative, phase I/II, single-arm, multicenter trial

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: October 28, 2024

Record last verified: 2024-10