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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Experimental | 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 |
|
| Placebo (no corticosteroid treatment) | Placebo Comparator | NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Indication for esophageal or pharyngeal surgical reconstruction | The primary outcome is the indication for esophageal or pharyngeal surgical reconstruction due to:
| within 12 months post ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Delay in the occurrence of refractory stenosis or pharyngeal stenosis | Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis | at 1 month |
| Delay in the occurrence of refractory stenosis or pharyngeal stenosis |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helene CORTE | Contact | 01.42.49.49.49 | helene.corte@aphp.fr | |
| Marie-Quitterie PICAT | Contact | 01.42.49.97.42 | marie-quitterie.picat@aphp.fr |
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| ID | Term |
|---|---|
| D004940 | Esophageal Stenosis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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Prospective Phase II, Bayesian, single-blinded, monocentric, randomized, prospective clinical trial
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single-blinded trial
|
| Placebo | Other | NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days |
|
|
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
| at 3 months |
| Delay in the occurrence of refractory stenosis or pharyngeal stenosis | Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis | at 6 months |
| Delay in the occurrence of refractory stenosis or pharyngeal stenosis | Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis | at 9 months |
| Delay in the occurrence of refractory esophagal stenosis or pharyngeal stenosis | Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis | at 12 months |
| Distance of the stenosis | Distance between the stenosis and the dental arches (cm) | at 1 month |
| Distance of the stenosis | Distance between the stenosis and the dental arches (cm) | at 3 months |
| Distance of the stenosis | Distance between the stenosis and the dental arches (cm) | at 6 months |
| Distance of the stenosis | Distance between the stenosis and the dental arches (cm) | at 9 months |
| Distance of the stenosis | Distance between the stenosis and the dental arches (cm) | at 12 months |
| Number of stenosis | Number of stenosis will be evaluated by endoscopy | at 1 month |
| Number of stenosis | Number of stenosis will be evaluated by endoscopy | at 3 months |
| Number of stenosis | Number of stenosis will be evaluated by endoscopy | at 6 months |
| Number of stenosis | Number of stenosis will be evaluated by endoscopy | at 9 months |
| Number of stenosis | Number of stenosis will be evaluated by endoscopy | at 12 months |
| Length of stenosis | Length of each stenosis will be evaluated by endoscopy | at 1 month |
| Length of stenosis | Length of each stenosis will be evaluated by endoscopy | at 3 months |
| Length of stenosis | Length of each stenosis will be evaluated by endoscopy | at 6 months |
| Length of stenosis | Length of each stenosis will be evaluated by endoscopy | at 9 months |
| Length of stenosis | Length of each stenosis will be evaluated by endoscopy | at 12 months |
| Estimated diameter of stenosis | Diameter of each stenosis will be evaluated by endoscopy | at 1 month |
| Estimated diameter of stenosis | Diameter of each stenosis will be evaluated by endoscopy | at 3 months |
| Estimated diameter of stenosis | Diameter of each stenosis will be evaluated by endoscopy | at 6 months |
| Estimated diameter of stenosis | Diameter of each stenosis will be evaluated by endoscopy | at 9 months |
| Estimated diameter of stenosis | Diameter of each stenosis will be evaluated by endoscopy | at 12 months |
| Endoluminal inflammation | Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe) | at 1 month |
| Endoluminal inflammation | Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe) | at 3 months |
| Endoluminal inflammation | Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe) | at 6 months |
| Endoluminal inflammation | Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe) | at 9 months |
| Endoluminal inflammation | Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe) | at 12 months |
| Number of dilation sessions | Number of dilation sessions evaluated by endoscopy | at 1 month |
| Number of dilation sessions | Number of dilation sessions evaluated by endoscopy | at 3 months |
| Number of dilation sessions | Number of dilation sessions evaluated by endoscopy | at 6 months |
| Number of dilation sessions | Number of dilation sessions evaluated by endoscopy | at 9 months |
| Number of dilation sessions | Number of dilation sessions evaluated by endoscopy | at 12 months |
| Intervals between iterative dilations | Time between endoscopic dilatations if necessary iterative dilation | at 1 month |
| Intervals between iterative dilations | Time between endoscopic dilatations if necessary iterative dilation | at 3 months |
| Intervals between iterative dilations | Time between endoscopic dilatations if necessary iterative dilation | at 6 months |
| Intervals between iterative dilations | Time between endoscopic dilatations if necessary iterative dilation | at 9 months |
| Intervals between iterative dilations | Time between endoscopic dilatations if necessary iterative dilation | at 12 months |
| Digestive perforations | Proportion of digestive perforations secondary to endoscopic dilation | at 1 month |
| Digestive perforations | Proportion of digestive perforations secondary to endoscopic dilation | at 3 months |
| Digestive perforations | Proportion of digestive perforations secondary to endoscopic dilation | at 6 months |
| Digestive perforations | Proportion of digestive perforations secondary to endoscopic dilation | at 9 months |
| Digestive perforations | Proportion of digestive perforations secondary to endoscopic dilation | at 12 months |
| Extent of pharyngeal stenosis | Laryngeal stenosis associated with pharyngeal stenosis | at 1 month |
| Extent of pharyngeal stenosis | Laryngeal stenosis associated with pharyngeal stenosis | at 3 months |
| Extent of pharyngeal stenosis | Laryngeal stenosis associated with pharyngeal stenosis | at 6 months |
| Extent of pharyngeal stenosis | Laryngeal stenosis associated with pharyngeal stenosis | at 9 months |
| Extent of pharyngeal stenosis | Laryngeal stenosis associated with pharyngeal stenosis | at 12 months |
| Proportion of unanticipated adverse reactions | Unanticipated adverse reactions will be defined by the occurrence of death,cardiac arrest whatever the cause,unplanned admission to intensive care unit (ICU) or extended stay > 24 ICU | at day 0 |
| Proportion of unanticipated adverse reactions | Unanticipated adverse reactions will be defined by the occurrence of death,cardiac arrest whatever the cause,unplanned admission to intensive care unit (ICU) or extended stay > 24 ICU | at day 2 |
| Proportion of unanticipated adverse reactions | Unanticipated adverse reactions will be defined by the occurrence of death,cardiac arrest whatever the cause,unplanned admission to intensive care unit (ICU) or extended stay > 24 ICU | at day 5 |
| Proportion of unanticipated adverse reactions | Unanticipated adverse reactions will be defined by the occurrence of death,cardiac arrest whatever the cause,unplanned admission to intensive care unit (ICU) or extended stay > 24 ICU | at day 7 |
| Proportion of unanticipated adverse reactions | Unanticipated adverse reactions will be defined by the occurrence of death,cardiac arrest whatever the cause,unplanned admission to intensive care unit (ICU) or extended stay > 24 ICU | at one month |
| Proportion of unanticipated adverse reactions | Unanticipated adverse reactions will be defined by the occurrence of death,cardiac arrest whatever the cause,unplanned admission to intensive care unit (ICU) or extended stay > 24 ICU | at 3 months |
| Proportion of unanticipated adverse reactions | Unanticipated adverse reactions will be defined by the occurrence of death,cardiac arrest whatever the cause,unplanned admission to intensive care unit (ICU) or extended stay > 24 ICU | at 6 months |
| Proportion of unanticipated adverse reactions | Unanticipated adverse reactions will be defined by the occurrence of death,cardiac arrest whatever the cause,unplanned admission to intensive care unit (ICU) or extended stay > 24 ICU | at 9 months |
| Proportion of unanticipated adverse reactions | Unanticipated adverse reactions will be defined by the occurrence of death,cardiac arrest whatever the cause,unplanned admission to intensive care unit (ICU) or extended stay > 24 ICU | at 12 months |
| Proportion of adverse reactions related to corticosteroid therapy | Adverse reactions related to corticosteroid therapy will be defined by the occurrence of infections needing antibiotic therapy or spontaneous digestive perforation or digestive bleeding or cardiac arrhythmias de novo or pulmonary edema requiring treatment (increased oxygen requirements and/or Diuretic and/or Vasodilator and/or non-invasive ventilation and/or invasive ventilation) or respiratory complications (High blood pressure requiring treatment - Metabolic alkalosis- Hypokalemia<3.0mmol/l - Delirium- Decompensation of a psychiatric pathology) | within 7 days |
| C-Reactive Protein (CRP) | Inflammation markers | at day 0 |
| C-Reactive Protein (CRP) | Inflammation markers | at day 2 |
| C-Reactive Protein (CRP) | Inflammation markers | at day 5 |
| C-Reactive Protein (CRP) | Inflammation markers | at one month |
| interleukin-1 (IL1) | Inflammation markers | at day 0 |
| interleukin-1 (IL1) | Inflammation markers | at day 2 |
| interleukin-1 (IL1) | Inflammation markers | at day 5 |
| interleukin-1 (IL1) | Inflammation markers | at one month |
| interleukin-6 (IL-6) | Inflammation markers | at day 0 |
| interleukin-6 (IL-6) | Inflammation markers | at day 2 |
| interleukin-6 (IL-6) | Inflammation markers | at day 5 |
| interleukin-6 (IL-6) | Inflammation markers | at one month |
| Tumour Necrosis Factor alpha (TNF alpha) | Inflammation markers | at day 0 |
| Tumour Necrosis Factor alpha (TNF alpha) | Inflammation markers | at day 2 |
| Tumour Necrosis Factor alpha (TNF alpha) | Inflammation markers | at day 5 |
| Tumour Necrosis Factor alpha (TNF alpha) | Inflammation markers | at one month |
| Tissue Growth Factor Beta (TGF beta) | Fibrosis markers | at day 0 |
| Tissue Growth Factor Beta (TGF beta) | Fibrosis markers | at day 2 |
| Tissue Growth Factor Beta (TGF beta) | Fibrosis markers | at day 5 |
| Tissue Growth Factor Beta (TGF beta) | Fibrosis markers | at one month |
| Galectin 3 | Fibrosis markers | at day 0 |
| Galectin 3 | Fibrosis markers | at day 2 |
| Galectin 3 | Fibrosis markers | at day 5 |
| Galectin 3 | Fibrosis markers | at one month |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |