Remplacement de l'œsophage Par Une Greffe d'œsophage Humain décellularisé
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Morbidity/mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Morbidity/mortality
时间窗: At 3 months after surgery
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
Nutritional autonomy
时间窗: At 12 months after esophageal replacement
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
次要结局
- Safety of the procedure(At 12 months after esophageal replacement)
- Presence of complete re-epithelialization, and integration into the native esophagus(At 12 months after surgery)
- Normal bolus transit(At 12 months after surgery)
- Esophageal manometry(At 12 months after surgery)
- Percentage of procedures interrupted for logistical reasons(Up to 14 months)
- Overall survival and Safety of procedure(At 12 months after surgery)
- Impact of procedure on quality of life(At 12 months after surgery)
- Estimating the cost of the procedure for one patient(At 12 months)
- Estimating the cost of the procedure for target population(At 12 months)