Clinical trial NCT06662370: Esophageal Replacement With a Decellularized Human Esophagus Graft
Official title: Remplacement de l'œsophage Par Une Greffe d'œsophage Humain décellularisé
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Esophageal Stenosis
Keywords: Tissue engineering
Esophageal replacement
Esophageal stenosis
Caustic injury
Radiotherapy
Anastomotic stenosis
Esophageal stent
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, non-comparative, phase I/II, single-arm, multicenter trial
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Morbidity/mortality
timeFrame: At 3 months after surgery
measure: Nutritional autonomy
timeFrame: At 12 months after esophageal replacement
Secondary outcomes:
measure: Safety of the procedure
timeFrame: At 12 months after esophageal replacement
measure: Presence of complete re-epithelialization, and integration into the native esophagus
timeFrame: At 3 months after surgery
measure: Presence of complete re-epithelialization, and integration into the native esophagus
timeFrame: At 12 months after surgery
measure: Normal bolus transit
timeFrame: At 6 months after surgery
measure: Normal bolus transit
timeFrame: At 12 months after surgery
measure: Esophageal manometry
timeFrame: At 12 months after surgery
measure: Percentage of procedures interrupted for logistical reasons
timeFrame: Up to 14 months
measure: Overall survival and Safety of procedure
timeFrame: At 12 months after surgery
measure: Impact of procedure on quality of life
timeFrame: At 6 months after surgery
measure: Impact of procedure on quality of life
timeFrame: At 12 months after surgery
measure: Impact of procedure on quality of life
timeFrame: At 6 months after surgery
measure: Impact of procedure on quality of life
timeFrame: At 12 months after surgery
measure: Estimating the cost of the procedure for one patient
timeFrame: At 12 months
measure: Estimating the cost of the procedure for target population
timeFrame: At 12 months
Other outcomes:
Locations:
Study officials:
References: