A Phase 2 interventional study of Methylprednisolone and Placebo in Caustic Esophageal Injury, Esophageal Stenosis and Pharyngeal Stenosis, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-30.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
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.
50 studies on the registry are indexed under Esophageal Stenosis; 11 are open to participants now.
This study's planned enrollment of 30 is above the median of 24 across 41 interventional studies indexed under Esophageal Stenosis.
Browse Esophageal Stenosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
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
Drug: Methylprednisolone
NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days
Other: Placebo
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
Also known as: 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
Also known as: Control Arm
Indication for esophageal or pharyngeal surgical reconstruction
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.
Time frame: within 12 months post ingestion
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
Time frame: at 1 month
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
Time frame: at 3 months
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
Time frame: at 6 months
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
Time frame: 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
Time frame: at 12 months
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Time frame: at 1 month
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Time frame: at 3 months
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Time frame: at 6 months
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Time frame: at 9 months
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Time frame: at 12 months
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Time frame: at 1 month
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Time frame: at 3 months
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Time frame: at 6 months
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Time frame: at 9 months
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Time frame: at 12 months
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Time frame: at 1 month
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Time frame: at 3 months
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Time frame: at 6 months
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Time frame: at 9 months
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Time frame: at 12 months
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Time frame: at 1 month
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Time frame: at 3 months
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Time frame: at 6 months
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Time frame: at 9 months
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Time frame: at 12 months
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Time frame: at 1 month
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Time frame: at 3 months
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Time frame: at 6 months
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Time frame: at 9 months
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Time frame: at 12 months
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Time frame: at 1 month
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Time frame: at 3 months
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Time frame: at 6 months
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Time frame: at 9 months
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Time frame: at 12 months
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Time frame: at 1 month
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Time frame: at 3 months
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Time frame: at 6 months
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Time frame: at 9 months
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Time frame: at 12 months
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Time frame: at 1 month
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Time frame: at 3 months
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Time frame: at 6 months
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Time frame: at 9 months
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Time frame: at 12 months
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Time frame: at 1 month
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Time frame: at 3 months
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Time frame: at 6 months
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Time frame: at 9 months
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: within 7 days
C-Reactive Protein (CRP)
Inflammation markers
Time frame: at day 0
C-Reactive Protein (CRP)
Inflammation markers
Time frame: at day 2
C-Reactive Protein (CRP)
Inflammation markers
Time frame: at day 5
C-Reactive Protein (CRP)
Inflammation markers
Time frame: at one month
interleukin-1 (IL1)
Inflammation markers
Time frame: at day 0
interleukin-1 (IL1)
Inflammation markers
Time frame: at day 2
interleukin-1 (IL1)
Inflammation markers
Time frame: at day 5
interleukin-1 (IL1)
Inflammation markers
Time frame: at one month
interleukin-6 (IL-6)
Inflammation markers
Time frame: at day 0
interleukin-6 (IL-6)
Inflammation markers
Time frame: at day 2
interleukin-6 (IL-6)
Inflammation markers
Time frame: at day 5
interleukin-6 (IL-6)
Inflammation markers
Time frame: at one month
Tumour Necrosis Factor alpha (TNF alpha)
Inflammation markers
Time frame: at day 0
Tumour Necrosis Factor alpha (TNF alpha)
Inflammation markers
Time frame: at day 2
Tumour Necrosis Factor alpha (TNF alpha)
Inflammation markers
Time frame: at day 5
Tumour Necrosis Factor alpha (TNF alpha)
Inflammation markers
Time frame: at one month
Tissue Growth Factor Beta (TGF beta)
Fibrosis markers
Time frame: at day 0
Tissue Growth Factor Beta (TGF beta)
Fibrosis markers
Time frame: at day 2
Tissue Growth Factor Beta (TGF beta)
Fibrosis markers
Time frame: at day 5
Tissue Growth Factor Beta (TGF beta)
Fibrosis markers
Time frame: at one month
Galectin 3
Fibrosis markers
Time frame: at day 0
Galectin 3
Fibrosis markers
Time frame: at day 2
Galectin 3
Fibrosis markers
Time frame: at day 5
Galectin 3
Fibrosis markers
Time frame: at one month
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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Assistance Publique - Hôpitaux de Paris