Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esophagus replacement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the procedure | The morbidity and mortality of the procedure will be defined by the occurrence of a complication such as leakage, sepsis, recurrent paralysis, esophageal stricture refractory to dilatation, anastomotic fistula, sepsis, esophageal perforation, cardio-respiratory complication (pneumopathy, pleural effusion, pulmonary embolism, AC/FA, infarction), death, tissue graft disintegration, postoperative tracheobronchial wound or oesotracheal fistula, or upper digestive obstruction after stent removal preventing any attempt to dilate the graft zone), for 12 months from the date of surgery. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
Contraindication to general anaesthesia, analgesics and antibiotics.
Conditions requiring long-term immunosuppressive or corticosteroid treatment.
Patients under curatorship or guardianship
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Cattan, MD PhD | Contact | +33142499116 | +33 | pierre.cattan@aphp.fr |
| Jérôme Lambert, MD PhD | Contact | +33142499742 | +33 | jerome.lambert@u-paris.fr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004940 | Esophageal Stenosis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Open-label, non-comparative, phase I/II, single-arm, multicenter trial
Not provided
Not provided
Not provided
Not provided
|
| At 12 months after esophageal replacement |
| Presence of complete re-epithelialization, and integration into the native esophagus | Assessed by endoscopy | At 3 months after surgery |
| Presence of complete re-epithelialization, and integration into the native esophagus | Assessed by CT scan with gel ingestion and intravenous contrast injection | At 12 months after surgery |
| Normal bolus transit | Assessed by barium deglutition | At 6 months after surgery |
| Normal bolus transit | Assessed by barium deglutition | At 12 months after surgery |
| Esophageal manometry | At 12 months after surgery |
| Percentage of procedures interrupted for logistical reasons | Logistical reasons are defined as :
| Up to 14 months |
| Overall survival and Safety of procedure | Patient survival at 12 months regardless of cause of death | At 12 months after surgery |
| Impact of procedure on quality of life | EORTC QLQ-OG25 module Score varying between 25 and 100, the higher the score the more severe the symptoms | At 6 months after surgery |
| Impact of procedure on quality of life | EORTC QLQ-OG25 module Score varying between 25 and 100, the higher the score the more severe the symptoms | At 12 months after surgery |
| Impact of procedure on quality of life | SF12V2 modules It is a 12 items score varying from to 0 to 100. The higher the score, the better the quality of life | At 6 months after surgery |
| Impact of procedure on quality of life | SF12V2 modules It is a 12 items score varying from to 0 to 100. The higher the score, the better the quality of life | At 12 months after surgery |
| Estimating the cost of the procedure for one patient | -Direct medical costs of the procedure: constitution (tissue engineering), storage and transport of the esophageal stent, hospital stay for graft surgery, emergency room visits, scheduled or unscheduled re-hospitalizations, follow-up in hospital consultations, scheduled or unscheduled outpatient physician visits, outpatient biological procedures, outpatient medical imaging, drug prescriptions, transport and coordination time by the expert team. | At 12 months |
| Estimating the cost of the procedure for target population | -Simulation using trial data of costs for all patients with esophageal transplant indication | At 12 months |