<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03760354</url>
  </required_header>
  <id_info>
    <org_study_id>P160803-J</org_study_id>
    <nct_id>NCT03760354</nct_id>
  </id_info>
  <brief_title>Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management</brief_title>
  <acronym>CORTICAU</acronym>
  <official_title>Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management for the Prevention of Refractory Stenosis of the Esophagus and Pharynx- The CORTICAU Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The management of patients who have ingested a caustic product has changed since 2007.&#xD;
      Whereas previously the lesion assessment and surgical indication were based on endoscopic&#xD;
      data, the therapeutic algorithm is currently based solely on the results of a CT scan with&#xD;
      contrast injection, performed 6 hours after ingestion. This examination makes it possible to&#xD;
      reliably assess the viability of the esophageal and gastric walls and thus to indicate&#xD;
      digestive resection. The therapeutic consequences of this new treatment are important&#xD;
      because, by expanding the indications for conservative treatment after severe ingestion, it&#xD;
      brings a significant gain in terms of survival, morbidity and functional outcome. In the&#xD;
      absence of emergency digestive resection, however, the functional prognosis is often&#xD;
      overshadowed by the formation of esophageal stenosis in the months following ingestion.&#xD;
      Patients then require endoscopic dilation treatment. In the event of failure or impossibility&#xD;
      of dilation, which defines refractory stenosis, esophageal reconstruction is necessary. In&#xD;
      case of sequential pharyngeal stenosis following ingestion, esophageal and pharyngeal&#xD;
      reconstruction is indicated as a first-line treatment, since these stenosis do not respond to&#xD;
      endoscopic dilations. The expansion of the indications for conservative treatment after&#xD;
      severe ingestion using CT scans has led to an increase in the incidence of after-effect&#xD;
      stenosis.&#xD;
&#xD;
      We aim to develop a therapeutic approach that will prevent the development of refractory and&#xD;
      pharyngeal esophageal stenosis. Indeed, there is currently no strategy that has proven&#xD;
      effective in this regard in adults. The value of corticosteroid therapy for the prevention of&#xD;
      caustic stenosis has only been evaluated in children and remains controversial.&#xD;
&#xD;
      The main objective is to evaluate the effect of early systemic corticosteroid therapy on the&#xD;
      risk of refractory esophageal or pharyngeal stenosis within one year of ingestion of a&#xD;
      caustic substance in a population of patients at high risk of stenosis, defined according to&#xD;
      tomodensitometric criteria (grade IIb: severe lesions, absence of transparietal necrosis),&#xD;
      and for whom there is no indication of urgent digestive resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">February 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 15, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective Phase II, Bayesian, single-blinded, monocentric, randomized, prospective clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>single-blinded trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Indication for esophageal or pharyngeal surgical reconstruction</measure>
    <time_frame>within 12 months post ingestion</time_frame>
    <description>The primary outcome is the indication for esophageal or pharyngeal surgical reconstruction due to:&#xD;
The occurrence of one or more esophageal stenosis refractory to endoscopic dilation within 12 months of ingestion, as defined by:&#xD;
The need for more than 5 sessions of esophageal endoscopic dilation&#xD;
Non-expandable stenosis or esophageal obstruction;&#xD;
An esophageal perforation that occurs during dilation, which contraindicates the continuation of dilation.&#xD;
The occurrence of pharyngeal stenosis, defined by the need to perform pharyngoplasty.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delay in the occurrence of refractory stenosis or pharyngeal stenosis</measure>
    <time_frame>at 1 month</time_frame>
    <description>Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay in the occurrence of refractory stenosis or pharyngeal stenosis</measure>
    <time_frame>at 3 months</time_frame>
    <description>Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay in the occurrence of refractory stenosis or pharyngeal stenosis</measure>
    <time_frame>at 6 months</time_frame>
    <description>Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay in the occurrence of refractory stenosis or pharyngeal stenosis</measure>
    <time_frame>at 9 months</time_frame>
    <description>Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay in the occurrence of refractory esophagal stenosis or pharyngeal stenosis</measure>
    <time_frame>at 12 months</time_frame>
    <description>Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance of the stenosis</measure>
    <time_frame>at 1 month</time_frame>
    <description>Distance between the stenosis and the dental arches (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance of the stenosis</measure>
    <time_frame>at 3 months</time_frame>
    <description>Distance between the stenosis and the dental arches (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance of the stenosis</measure>
    <time_frame>at 6 months</time_frame>
    <description>Distance between the stenosis and the dental arches (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance of the stenosis</measure>
    <time_frame>at 9 months</time_frame>
    <description>Distance between the stenosis and the dental arches (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance of the stenosis</measure>
    <time_frame>at 12 months</time_frame>
    <description>Distance between the stenosis and the dental arches (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of stenosis</measure>
    <time_frame>at 1 month</time_frame>
    <description>Number of stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of stenosis</measure>
    <time_frame>at 3 months</time_frame>
    <description>Number of stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of stenosis</measure>
    <time_frame>at 6 months</time_frame>
    <description>Number of stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of stenosis</measure>
    <time_frame>at 9 months</time_frame>
    <description>Number of stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of stenosis</measure>
    <time_frame>at 12 months</time_frame>
    <description>Number of stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stenosis</measure>
    <time_frame>at 1 month</time_frame>
    <description>Length of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stenosis</measure>
    <time_frame>at 3 months</time_frame>
    <description>Length of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stenosis</measure>
    <time_frame>at 6 months</time_frame>
    <description>Length of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stenosis</measure>
    <time_frame>at 9 months</time_frame>
    <description>Length of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stenosis</measure>
    <time_frame>at 12 months</time_frame>
    <description>Length of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated diameter of stenosis</measure>
    <time_frame>at 1 month</time_frame>
    <description>Diameter of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated diameter of stenosis</measure>
    <time_frame>at 3 months</time_frame>
    <description>Diameter of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated diameter of stenosis</measure>
    <time_frame>at 6 months</time_frame>
    <description>Diameter of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated diameter of stenosis</measure>
    <time_frame>at 9 months</time_frame>
    <description>Diameter of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated diameter of stenosis</measure>
    <time_frame>at 12 months</time_frame>
    <description>Diameter of each stenosis will be evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoluminal inflammation</measure>
    <time_frame>at 1 month</time_frame>
    <description>Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoluminal inflammation</measure>
    <time_frame>at 3 months</time_frame>
    <description>Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoluminal inflammation</measure>
    <time_frame>at 6 months</time_frame>
    <description>Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoluminal inflammation</measure>
    <time_frame>at 9 months</time_frame>
    <description>Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoluminal inflammation</measure>
    <time_frame>at 12 months</time_frame>
    <description>Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of dilation sessions</measure>
    <time_frame>at 1 month</time_frame>
    <description>Number of dilation sessions evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of dilation sessions</measure>
    <time_frame>at 3 months</time_frame>
    <description>Number of dilation sessions evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of dilation sessions</measure>
    <time_frame>at 6 months</time_frame>
    <description>Number of dilation sessions evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of dilation sessions</measure>
    <time_frame>at 9 months</time_frame>
    <description>Number of dilation sessions evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of dilation sessions</measure>
    <time_frame>at 12 months</time_frame>
    <description>Number of dilation sessions evaluated by endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervals between iterative dilations</measure>
    <time_frame>at 1 month</time_frame>
    <description>Time between endoscopic dilatations if necessary iterative dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervals between iterative dilations</measure>
    <time_frame>at 3 months</time_frame>
    <description>Time between endoscopic dilatations if necessary iterative dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervals between iterative dilations</measure>
    <time_frame>at 6 months</time_frame>
    <description>Time between endoscopic dilatations if necessary iterative dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervals between iterative dilations</measure>
    <time_frame>at 9 months</time_frame>
    <description>Time between endoscopic dilatations if necessary iterative dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervals between iterative dilations</measure>
    <time_frame>at 12 months</time_frame>
    <description>Time between endoscopic dilatations if necessary iterative dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digestive perforations</measure>
    <time_frame>at 1 month</time_frame>
    <description>Proportion of digestive perforations secondary to endoscopic dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digestive perforations</measure>
    <time_frame>at 3 months</time_frame>
    <description>Proportion of digestive perforations secondary to endoscopic dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digestive perforations</measure>
    <time_frame>at 6 months</time_frame>
    <description>Proportion of digestive perforations secondary to endoscopic dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digestive perforations</measure>
    <time_frame>at 9 months</time_frame>
    <description>Proportion of digestive perforations secondary to endoscopic dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digestive perforations</measure>
    <time_frame>at 12 months</time_frame>
    <description>Proportion of digestive perforations secondary to endoscopic dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of pharyngeal stenosis</measure>
    <time_frame>at 1 month</time_frame>
    <description>Laryngeal stenosis associated with pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of pharyngeal stenosis</measure>
    <time_frame>at 3 months</time_frame>
    <description>Laryngeal stenosis associated with pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of pharyngeal stenosis</measure>
    <time_frame>at 6 months</time_frame>
    <description>Laryngeal stenosis associated with pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of pharyngeal stenosis</measure>
    <time_frame>at 9 months</time_frame>
    <description>Laryngeal stenosis associated with pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of pharyngeal stenosis</measure>
    <time_frame>at 12 months</time_frame>
    <description>Laryngeal stenosis associated with pharyngeal stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of unanticipated adverse reactions</measure>
    <time_frame>at day 0</time_frame>
    <description>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 &gt; 24 ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of unanticipated adverse reactions</measure>
    <time_frame>at day 2</time_frame>
    <description>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 &gt; 24 ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of unanticipated adverse reactions</measure>
    <time_frame>at day 5</time_frame>
    <description>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 &gt; 24 ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of unanticipated adverse reactions</measure>
    <time_frame>at day 7</time_frame>
    <description>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 &gt; 24 ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of unanticipated adverse reactions</measure>
    <time_frame>at one month</time_frame>
    <description>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 &gt; 24 ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of unanticipated adverse reactions</measure>
    <time_frame>at 3 months</time_frame>
    <description>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 &gt; 24 ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of unanticipated adverse reactions</measure>
    <time_frame>at 6 months</time_frame>
    <description>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 &gt; 24 ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of unanticipated adverse reactions</measure>
    <time_frame>at 9 months</time_frame>
    <description>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 &gt; 24 ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of unanticipated adverse reactions</measure>
    <time_frame>at 12 months</time_frame>
    <description>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 &gt; 24 ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of adverse reactions related to corticosteroid therapy</measure>
    <time_frame>within 7 days</time_frame>
    <description>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&lt;3.0mmol/l - Delirium- Decompensation of a psychiatric pathology)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Reactive Protein (CRP)</measure>
    <time_frame>at day 0</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Reactive Protein (CRP)</measure>
    <time_frame>at day 2</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Reactive Protein (CRP)</measure>
    <time_frame>at day 5</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Reactive Protein (CRP)</measure>
    <time_frame>at one month</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-1 (IL1)</measure>
    <time_frame>at day 0</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-1 (IL1)</measure>
    <time_frame>at day 2</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-1 (IL1)</measure>
    <time_frame>at day 5</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-1 (IL1)</measure>
    <time_frame>at one month</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-6 (IL-6)</measure>
    <time_frame>at day 0</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-6 (IL-6)</measure>
    <time_frame>at day 2</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-6 (IL-6)</measure>
    <time_frame>at day 5</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-6 (IL-6)</measure>
    <time_frame>at one month</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumour Necrosis Factor alpha (TNF alpha)</measure>
    <time_frame>at day 0</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumour Necrosis Factor alpha (TNF alpha)</measure>
    <time_frame>at day 2</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumour Necrosis Factor alpha (TNF alpha)</measure>
    <time_frame>at day 5</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumour Necrosis Factor alpha (TNF alpha)</measure>
    <time_frame>at one month</time_frame>
    <description>Inflammation markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue Growth Factor Beta (TGF beta)</measure>
    <time_frame>at day 0</time_frame>
    <description>Fibrosis markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue Growth Factor Beta (TGF beta)</measure>
    <time_frame>at day 2</time_frame>
    <description>Fibrosis markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue Growth Factor Beta (TGF beta)</measure>
    <time_frame>at day 5</time_frame>
    <description>Fibrosis markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue Growth Factor Beta (TGF beta)</measure>
    <time_frame>at one month</time_frame>
    <description>Fibrosis markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Galectin 3</measure>
    <time_frame>at day 0</time_frame>
    <description>Fibrosis markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Galectin 3</measure>
    <time_frame>at day 2</time_frame>
    <description>Fibrosis markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Galectin 3</measure>
    <time_frame>at day 5</time_frame>
    <description>Fibrosis markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Galectin 3</measure>
    <time_frame>at one month</time_frame>
    <description>Fibrosis markers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Caustic Esophageal Injury</condition>
  <condition>Esophageal Stenosis</condition>
  <condition>Pharyngeal Stenosis</condition>
  <arm_group>
    <arm_group_label>Methylprednisolone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (no corticosteroid treatment)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>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</description>
    <arm_group_label>Methylprednisolone</arm_group_label>
    <other_name>Corticosteroid treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days</description>
    <arm_group_label>Placebo (no corticosteroid treatment)</arm_group_label>
    <other_name>Control Arm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Recent caustic product ingestion (time between taking the product and initiating the&#xD;
             evaluated treatment or placebo between 6 and 24 hours after ingestion)&#xD;
&#xD;
          -  Predictive CT criteria for high-risk esophageal stenosis (grade IIb) in its most&#xD;
             pathological part&#xD;
&#xD;
          -  Written, signed consent (trusted person if necessary, in case of impossibility of&#xD;
             collection)&#xD;
&#xD;
          -  Beneficiary of a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indication of resection or surgical exploration in emergency&#xD;
&#xD;
          -  History of caustic ingestion&#xD;
&#xD;
          -  Corticosteroids taken at a dose greater than 20 mg prednisone within 7 days before&#xD;
             randomization&#xD;
&#xD;
          -  Contraindication to corticosteroid therapy:&#xD;
&#xD;
          -  Any infectious condition that required antibiotic treatment within 7 days of&#xD;
             randomization&#xD;
&#xD;
          -  Any vaccine living within 7 days of randomization&#xD;
&#xD;
          -  Hypersensitivity to one of the components&#xD;
&#xD;
          -  Pregnancy in progress&#xD;
&#xD;
          -  Breastfeeding in progress&#xD;
&#xD;
          -  Co-intoxication involving vital prognosis and requiring, according to the patient's&#xD;
             doctor, intensive care management&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Helene CORTE</last_name>
    <phone>01.42.49.49.49</phone>
    <email>helene.corte@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie-Quitterie PICAT</last_name>
    <phone>01.42.49.97.42</phone>
    <email>marie-quitterie.picat@aphp.fr</email>
  </overall_contact_backup>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caustic</keyword>
  <keyword>Esophageal Stenosis</keyword>
  <keyword>Pharyngeal Stenosis</keyword>
  <keyword>Corticosteroid treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03760354
org study id: P160803-J
nct id: NCT03760354
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective Phase II, Bayesian, single-blinded, monocentric, randomized, prospective clinical trial
primary purpose: Treatment
masking: Single (Participant)
masking description: single-blinded trial
measure: Indication for esophageal or pharyngeal surgical reconstruction
time frame: within 12 months post ingestion
description: The primary outcome is the indication for esophageal or pharyngeal surgical reconstruction due to:
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.
The occurrence of pharyngeal stenosis, defined by the need to perform pharyngoplasty.
measure: Delay in the occurrence of refractory stenosis or pharyngeal stenosis
time frame: at 1 month
description: Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
measure: Delay in the occurrence of refractory stenosis or pharyngeal stenosis
time frame: at 3 months
description: Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
measure: Delay in the occurrence of refractory stenosis or pharyngeal stenosis
time frame: at 6 months
description: Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
measure: Delay in the occurrence of refractory stenosis or pharyngeal stenosis
time frame: at 9 months
description: Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
measure: Delay in the occurrence of refractory esophagal stenosis or pharyngeal stenosis
time frame: at 12 months
description: Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
measure: Distance of the stenosis
time frame: at 1 month
description: Distance between the stenosis and the dental arches (cm)
measure: Distance of the stenosis
time frame: at 3 months
description: Distance between the stenosis and the dental arches (cm)
measure: Distance of the stenosis
time frame: at 6 months
description: Distance between the stenosis and the dental arches (cm)
measure: Distance of the stenosis
time frame: at 9 months
description: Distance between the stenosis and the dental arches (cm)
measure: Distance of the stenosis
time frame: at 12 months
description: Distance between the stenosis and the dental arches (cm)
measure: Number of stenosis
time frame: at 1 month
description: Number of stenosis will be evaluated by endoscopy
measure: Number of stenosis
time frame: at 3 months
description: Number of stenosis will be evaluated by endoscopy
measure: Number of stenosis
time frame: at 6 months
description: Number of stenosis will be evaluated by endoscopy
measure: Number of stenosis
time frame: at 9 months
description: Number of stenosis will be evaluated by endoscopy
measure: Number of stenosis
time frame: at 12 months
description: Number of stenosis will be evaluated by endoscopy
measure: Length of stenosis
time frame: at 1 month
description: Length of each stenosis will be evaluated by endoscopy
measure: Length of stenosis
time frame: at 3 months
description: Length of each stenosis will be evaluated by endoscopy
measure: Length of stenosis
time frame: at 6 months
description: Length of each stenosis will be evaluated by endoscopy
measure: Length of stenosis
time frame: at 9 months
description: Length of each stenosis will be evaluated by endoscopy
measure: Length of stenosis
time frame: at 12 months
description: Length of each stenosis will be evaluated by endoscopy
measure: Estimated diameter of stenosis
time frame: at 1 month
description: Diameter of each stenosis will be evaluated by endoscopy
measure: Estimated diameter of stenosis
time frame: at 3 months
description: Diameter of each stenosis will be evaluated by endoscopy
measure: Estimated diameter of stenosis
time frame: at 6 months
description: Diameter of each stenosis will be evaluated by endoscopy
measure: Estimated diameter of stenosis
time frame: at 9 months
description: Diameter of each stenosis will be evaluated by endoscopy
measure: Estimated diameter of stenosis
time frame: at 12 months
description: Diameter of each stenosis will be evaluated by endoscopy
measure: Endoluminal inflammation
time frame: at 1 month
description: Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
measure: Endoluminal inflammation
time frame: at 3 months
description: Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
measure: Endoluminal inflammation
time frame: at 6 months
description: Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
measure: Endoluminal inflammation
time frame: at 9 months
description: Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
measure: Endoluminal inflammation
time frame: at 12 months
description: Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
measure: Number of dilation sessions
time frame: at 1 month
description: Number of dilation sessions evaluated by endoscopy
measure: Number of dilation sessions
time frame: at 3 months
description: Number of dilation sessions evaluated by endoscopy
measure: Number of dilation sessions
time frame: at 6 months
description: Number of dilation sessions evaluated by endoscopy
measure: Number of dilation sessions
time frame: at 9 months
description: Number of dilation sessions evaluated by endoscopy
measure: Number of dilation sessions
time frame: at 12 months
description: Number of dilation sessions evaluated by endoscopy
measure: Intervals between iterative dilations
time frame: at 1 month
description: Time between endoscopic dilatations if necessary iterative dilation
measure: Intervals between iterative dilations
time frame: at 3 months
description: Time between endoscopic dilatations if necessary iterative dilation
measure: Intervals between iterative dilations
time frame: at 6 months
description: Time between endoscopic dilatations if necessary iterative dilation
measure: Intervals between iterative dilations
time frame: at 9 months
description: Time between endoscopic dilatations if necessary iterative dilation
measure: Intervals between iterative dilations
time frame: at 12 months
description: Time between endoscopic dilatations if necessary iterative dilation
measure: Digestive perforations
time frame: at 1 month
description: Proportion of digestive perforations secondary to endoscopic dilation
measure: Digestive perforations
time frame: at 3 months
description: Proportion of digestive perforations secondary to endoscopic dilation
measure: Digestive perforations
time frame: at 6 months
description: Proportion of digestive perforations secondary to endoscopic dilation
measure: Digestive perforations
time frame: at 9 months
description: Proportion of digestive perforations secondary to endoscopic dilation
measure: Digestive perforations
time frame: at 12 months
description: Proportion of digestive perforations secondary to endoscopic dilation
measure: Extent of pharyngeal stenosis
time frame: at 1 month
description: Laryngeal stenosis associated with pharyngeal stenosis
measure: Extent of pharyngeal stenosis
time frame: at 3 months
description: Laryngeal stenosis associated with pharyngeal stenosis
measure: Extent of pharyngeal stenosis
time frame: at 6 months
description: Laryngeal stenosis associated with pharyngeal stenosis
measure: Extent of pharyngeal stenosis
time frame: at 9 months
description: Laryngeal stenosis associated with pharyngeal stenosis
measure: Extent of pharyngeal stenosis
time frame: at 12 months
description: Laryngeal stenosis associated with pharyngeal stenosis
measure: Proportion of unanticipated adverse reactions
time frame: at day 0
description: 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
measure: Proportion of unanticipated adverse reactions
time frame: at day 2
description: 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
measure: Proportion of unanticipated adverse reactions
time frame: at day 5
description: 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
measure: Proportion of unanticipated adverse reactions
time frame: at day 7
description: 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
measure: Proportion of unanticipated adverse reactions
time frame: at one month
description: 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
measure: Proportion of unanticipated adverse reactions
time frame: at 3 months
description: 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
measure: Proportion of unanticipated adverse reactions
time frame: at 6 months
description: 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
measure: Proportion of unanticipated adverse reactions
time frame: at 9 months
description: 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
measure: Proportion of unanticipated adverse reactions
time frame: at 12 months
description: 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
measure: Proportion of adverse reactions related to corticosteroid therapy
time frame: within 7 days
description: 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)
measure: C-Reactive Protein (CRP)
time frame: at day 0
description: Inflammation markers
measure: C-Reactive Protein (CRP)
time frame: at day 2
description: Inflammation markers
measure: C-Reactive Protein (CRP)
time frame: at day 5
description: Inflammation markers
measure: C-Reactive Protein (CRP)
time frame: at one month
description: Inflammation markers
measure: interleukin-1 (IL1)
time frame: at day 0
description: Inflammation markers
measure: interleukin-1 (IL1)
time frame: at day 2
description: Inflammation markers
measure: interleukin-1 (IL1)
time frame: at day 5
description: Inflammation markers
measure: interleukin-1 (IL1)
time frame: at one month
description: Inflammation markers
measure: interleukin-6 (IL-6)
time frame: at day 0
description: Inflammation markers
measure: interleukin-6 (IL-6)
time frame: at day 2
description: Inflammation markers
measure: interleukin-6 (IL-6)
time frame: at day 5
description: Inflammation markers
measure: interleukin-6 (IL-6)
time frame: at one month
description: Inflammation markers
measure: Tumour Necrosis Factor alpha (TNF alpha)
time frame: at day 0
description: Inflammation markers
measure: Tumour Necrosis Factor alpha (TNF alpha)
time frame: at day 2
description: Inflammation markers
measure: Tumour Necrosis Factor alpha (TNF alpha)
time frame: at day 5
description: Inflammation markers
measure: Tumour Necrosis Factor alpha (TNF alpha)
time frame: at one month
description: Inflammation markers
measure: Tissue Growth Factor Beta (TGF beta)
time frame: at day 0
description: Fibrosis markers
measure: Tissue Growth Factor Beta (TGF beta)
time frame: at day 2
description: Fibrosis markers
measure: Tissue Growth Factor Beta (TGF beta)
time frame: at day 5
description: Fibrosis markers
measure: Tissue Growth Factor Beta (TGF beta)
time frame: at one month
description: Fibrosis markers
measure: Galectin 3
time frame: at day 0
description: Fibrosis markers
measure: Galectin 3
time frame: at day 2
description: Fibrosis markers
measure: Galectin 3
time frame: at day 5
description: Fibrosis markers
measure: Galectin 3
time frame: at one month
description: Fibrosis markers
arm group label: Methylprednisolone
arm group type: Experimental
description: 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
arm group label: Placebo (no corticosteroid treatment)
arm group type: Placebo Comparator
description: NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days
intervention type: Drug
intervention name: Methylprednisolone
description: 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
arm group label: Methylprednisolone
other name: Corticosteroid treatment
intervention type: Other
intervention name: Placebo
description: NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days
arm group label: Placebo (no corticosteroid treatment)
other name: Control Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Helene CORTE
phone: 01.42.49.49.49
email: helene.corte@aphp.fr
last name: Marie-Quitterie PICAT
phone: 01.42.49.97.42
email: marie-quitterie.picat@aphp.fr
responsible party type: Sponsor
mesh term: Esophageal Stenosis
mesh term: Constriction, Pathologic
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: Undecided