Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management for the Prevention of Refractory Stenosis of the Esophagus and Pharynx- The CORTICAU Study
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 主要终点
- Indication for esophageal or pharyngeal surgical reconstruction
研究概览
简要总结
The management of patients who have ingested a caustic product has changed since 2007. Whereas previously the lesion assessment and surgical indication were based on endoscopic data, the therapeutic algorithm is currently based solely on the results of a CT scan with contrast injection, performed 6 hours after ingestion. This examination makes it possible to reliably assess the viability of the esophageal and gastric walls and thus to indicate digestive resection. The therapeutic consequences of this new treatment are important because, by expanding the indications for conservative treatment after severe ingestion, it brings a significant gain in terms of survival, morbidity and functional outcome. In the absence of emergency digestive resection, however, the functional prognosis is often overshadowed by the formation of esophageal stenosis in the months following ingestion. Patients then require endoscopic dilation treatment. In the event of failure or impossibility of dilation, which defines refractory stenosis, esophageal reconstruction is necessary. In case of sequential pharyngeal stenosis following ingestion, esophageal and pharyngeal reconstruction is indicated as a first-line treatment, since these stenosis do not respond to endoscopic dilations. The expansion of the indications for conservative treatment after severe ingestion using CT scans has led to an increase in the incidence of after-effect stenosis.
We aim to develop a therapeutic approach that will prevent the development of refractory and pharyngeal esophageal stenosis. Indeed, there is currently no strategy that has proven effective in this regard in adults. The value of corticosteroid therapy for the prevention of caustic stenosis has only been evaluated in children and remains controversial.
The main objective is to evaluate the effect of early systemic corticosteroid therapy on the risk of refractory esophageal or pharyngeal stenosis within one year of ingestion of a caustic substance in a population of patients at high risk of stenosis, defined according to tomodensitometric criteria (grade IIb: severe lesions, absence of transparietal necrosis), and for whom there is no indication of urgent digestive resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
single-blinded trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Indication of resection or surgical exploration in emergency
- •History of caustic ingestion
- •Corticosteroids taken at a dose greater than 20 mg prednisone within 7 days before randomization
- •Contraindication to corticosteroid therapy:
- •Any infectious condition that required antibiotic treatment within 7 days of randomization
- •Any vaccine living within 7 days of randomization
- •Hypersensitivity to one of the components
- •Pregnancy in progress
- •Breastfeeding in progress
- •Co-intoxication involving vital prognosis and requiring, according to the patient's doctor, intensive care management
- •Patient under guardianship or curatorship
研究组 & 干预措施
Methylprednisolone
Dose: 500mg/day for the first two days then 2mg/kg per day for three days. Dilution in 0.9% NaCl, 100 ml as a single slow intravenous administration over 60 minutes Total processing time of 5 days
干预措施: Methylprednisolone (Drug)
Placebo (no corticosteroid treatment)
NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days
干预措施: Placebo (Other)
结局指标
主要结局
Indication for esophageal or pharyngeal surgical reconstruction
时间窗: within 12 months post ingestion
The primary outcome is the indication for esophageal or pharyngeal surgical reconstruction due to: 1. The occurrence of one or more esophageal stenosis refractory to endoscopic dilation within 12 months of ingestion, as defined by: * The need for more than 5 sessions of esophageal endoscopic dilation * Non-expandable stenosis or esophageal obstruction; * An esophageal perforation that occurs during dilation, which contraindicates the continuation of dilation. 2. The occurrence of pharyngeal stenosis, defined by the need to perform pharyngoplasty.
次要结局
- Digestive perforations(at 12 months)
- Delay in the occurrence of refractory stenosis or pharyngeal stenosis(at 9 months)
- Delay in the occurrence of refractory esophagal stenosis or pharyngeal stenosis(at 12 months)
- Distance of the stenosis(at 12 months)
- Number of stenosis(at 12 months)
- Length of stenosis(at 12 months)
- Estimated diameter of stenosis(at 12 months)
- Endoluminal inflammation(at 12 months)
- Number of dilation sessions(at 12 months)
- Intervals between iterative dilations(at 12 months)
- Extent of pharyngeal stenosis(at 12 months)
- Proportion of unanticipated adverse reactions(at 12 months)
- Proportion of adverse reactions related to corticosteroid therapy(within 7 days)
- C-Reactive Protein (CRP)(at one month)
- Tissue Growth Factor Beta (TGF beta)(at one month)
- interleukin-6 (IL-6)(at one month)
- Tumour Necrosis Factor alpha (TNF alpha)(at one month)
- interleukin-1 (IL1)(at one month)
- Galectin 3(at one month)