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Trial record 3 of 7 for:    "Esophageal Disease" | "Methylprednisolone"

Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management (CORTICAU)

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ClinicalTrials.gov Identifier: NCT03760354
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Caustic Esophageal Injury Esophageal Stenosis Pharyngeal Stenosis Drug: Methylprednisolone Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Phase II, Bayesian, single-blinded, monocentric, randomized, prospective clinical trial
Masking: Single (Participant)
Masking Description: single-blinded trial
Primary Purpose: Treatment
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
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: 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
Drug: 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
Other Name: Corticosteroid treatment

Placebo Comparator: 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
Other: Placebo
NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days
Other Name: Control Arm




Primary Outcome Measures :
  1. Indication for esophageal or pharyngeal surgical reconstruction [ Time Frame: 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.


Secondary Outcome Measures :
  1. Delay in the occurrence of refractory stenosis or pharyngeal stenosis [ Time Frame: at 1 month ]
    Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis

  2. Delay in the occurrence of refractory stenosis or pharyngeal stenosis [ Time Frame: at 3 months ]
    Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis

  3. Delay in the occurrence of refractory stenosis or pharyngeal stenosis [ Time Frame: at 6 months ]
    Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis

  4. Delay in the occurrence of refractory stenosis or pharyngeal stenosis [ Time Frame: at 9 months ]
    Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis

  5. Delay in the occurrence of refractory esophagal stenosis or pharyngeal stenosis [ Time Frame: at 12 months ]
    Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis

  6. Distance of the stenosis [ Time Frame: at 1 month ]
    Distance between the stenosis and the dental arches (cm)

  7. Distance of the stenosis [ Time Frame: at 3 months ]
    Distance between the stenosis and the dental arches (cm)

  8. Distance of the stenosis [ Time Frame: at 6 months ]
    Distance between the stenosis and the dental arches (cm)

  9. Distance of the stenosis [ Time Frame: at 9 months ]
    Distance between the stenosis and the dental arches (cm)

  10. Distance of the stenosis [ Time Frame: at 12 months ]
    Distance between the stenosis and the dental arches (cm)

  11. Number of stenosis [ Time Frame: at 1 month ]
    Number of stenosis will be evaluated by endoscopy

  12. Number of stenosis [ Time Frame: at 3 months ]
    Number of stenosis will be evaluated by endoscopy

  13. Number of stenosis [ Time Frame: at 6 months ]
    Number of stenosis will be evaluated by endoscopy

  14. Number of stenosis [ Time Frame: at 9 months ]
    Number of stenosis will be evaluated by endoscopy

  15. Number of stenosis [ Time Frame: at 12 months ]
    Number of stenosis will be evaluated by endoscopy

  16. Length of stenosis [ Time Frame: at 1 month ]
    Length of each stenosis will be evaluated by endoscopy

  17. Length of stenosis [ Time Frame: at 3 months ]
    Length of each stenosis will be evaluated by endoscopy

  18. Length of stenosis [ Time Frame: at 6 months ]
    Length of each stenosis will be evaluated by endoscopy

  19. Length of stenosis [ Time Frame: at 9 months ]
    Length of each stenosis will be evaluated by endoscopy

  20. Length of stenosis [ Time Frame: at 12 months ]
    Length of each stenosis will be evaluated by endoscopy

  21. Estimated diameter of stenosis [ Time Frame: at 1 month ]
    Diameter of each stenosis will be evaluated by endoscopy

  22. Estimated diameter of stenosis [ Time Frame: at 3 months ]
    Diameter of each stenosis will be evaluated by endoscopy

  23. Estimated diameter of stenosis [ Time Frame: at 6 months ]
    Diameter of each stenosis will be evaluated by endoscopy

  24. Estimated diameter of stenosis [ Time Frame: at 9 months ]
    Diameter of each stenosis will be evaluated by endoscopy

  25. Estimated diameter of stenosis [ Time Frame: at 12 months ]
    Diameter of each stenosis will be evaluated by endoscopy

  26. Endoluminal inflammation [ Time Frame: at 1 month ]
    Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)

  27. Endoluminal inflammation [ Time Frame: at 3 months ]
    Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)

  28. Endoluminal inflammation [ Time Frame: at 6 months ]
    Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)

  29. Endoluminal inflammation [ Time Frame: at 9 months ]
    Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)

  30. Endoluminal inflammation [ Time Frame: at 12 months ]
    Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)

  31. Number of dilation sessions [ Time Frame: at 1 month ]
    Number of dilation sessions evaluated by endoscopy

  32. Number of dilation sessions [ Time Frame: at 3 months ]
    Number of dilation sessions evaluated by endoscopy

  33. Number of dilation sessions [ Time Frame: at 6 months ]
    Number of dilation sessions evaluated by endoscopy

  34. Number of dilation sessions [ Time Frame: at 9 months ]
    Number of dilation sessions evaluated by endoscopy

  35. Number of dilation sessions [ Time Frame: at 12 months ]
    Number of dilation sessions evaluated by endoscopy

  36. Intervals between iterative dilations [ Time Frame: at 1 month ]
    Time between endoscopic dilatations if necessary iterative dilation

  37. Intervals between iterative dilations [ Time Frame: at 3 months ]
    Time between endoscopic dilatations if necessary iterative dilation

  38. Intervals between iterative dilations [ Time Frame: at 6 months ]
    Time between endoscopic dilatations if necessary iterative dilation

  39. Intervals between iterative dilations [ Time Frame: at 9 months ]
    Time between endoscopic dilatations if necessary iterative dilation

  40. Intervals between iterative dilations [ Time Frame: at 12 months ]
    Time between endoscopic dilatations if necessary iterative dilation

  41. Digestive perforations [ Time Frame: at 1 month ]
    Proportion of digestive perforations secondary to endoscopic dilation

  42. Digestive perforations [ Time Frame: at 3 months ]
    Proportion of digestive perforations secondary to endoscopic dilation

  43. Digestive perforations [ Time Frame: at 6 months ]
    Proportion of digestive perforations secondary to endoscopic dilation

  44. Digestive perforations [ Time Frame: at 9 months ]
    Proportion of digestive perforations secondary to endoscopic dilation

  45. Digestive perforations [ Time Frame: at 12 months ]
    Proportion of digestive perforations secondary to endoscopic dilation

  46. Extent of pharyngeal stenosis [ Time Frame: at 1 month ]
    Laryngeal stenosis associated with pharyngeal stenosis

  47. Extent of pharyngeal stenosis [ Time Frame: at 3 months ]
    Laryngeal stenosis associated with pharyngeal stenosis

  48. Extent of pharyngeal stenosis [ Time Frame: at 6 months ]
    Laryngeal stenosis associated with pharyngeal stenosis

  49. Extent of pharyngeal stenosis [ Time Frame: at 9 months ]
    Laryngeal stenosis associated with pharyngeal stenosis

  50. Extent of pharyngeal stenosis [ Time Frame: at 12 months ]
    Laryngeal stenosis associated with pharyngeal stenosis

  51. Proportion of unanticipated adverse reactions [ Time Frame: at day 0 ]
    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

  52. Proportion of unanticipated adverse reactions [ Time Frame: at day 2 ]
    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

  53. Proportion of unanticipated adverse reactions [ Time Frame: at day 5 ]
    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

  54. Proportion of unanticipated adverse reactions [ Time Frame: at day 7 ]
    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

  55. Proportion of unanticipated adverse reactions [ Time Frame: at one month ]
    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

  56. Proportion of unanticipated adverse reactions [ Time Frame: at 3 months ]
    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

  57. Proportion of unanticipated adverse reactions [ Time Frame: at 6 months ]
    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

  58. Proportion of unanticipated adverse reactions [ Time Frame: at 9 months ]
    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

  59. Proportion of unanticipated adverse reactions [ Time Frame: at 12 months ]
    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

  60. Proportion of adverse reactions related to corticosteroid therapy [ Time Frame: within 7 days ]
    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)

  61. C-Reactive Protein (CRP) [ Time Frame: at day 0 ]
    Inflammation markers

  62. C-Reactive Protein (CRP) [ Time Frame: at day 2 ]
    Inflammation markers

  63. C-Reactive Protein (CRP) [ Time Frame: at day 5 ]
    Inflammation markers

  64. C-Reactive Protein (CRP) [ Time Frame: at one month ]
    Inflammation markers

  65. interleukin-1 (IL1) [ Time Frame: at day 0 ]
    Inflammation markers

  66. interleukin-1 (IL1) [ Time Frame: at day 2 ]
    Inflammation markers

  67. interleukin-1 (IL1) [ Time Frame: at day 5 ]
    Inflammation markers

  68. interleukin-1 (IL1) [ Time Frame: at one month ]
    Inflammation markers

  69. interleukin-6 (IL-6) [ Time Frame: at day 0 ]
    Inflammation markers

  70. interleukin-6 (IL-6) [ Time Frame: at day 2 ]
    Inflammation markers

  71. interleukin-6 (IL-6) [ Time Frame: at day 5 ]
    Inflammation markers

  72. interleukin-6 (IL-6) [ Time Frame: at one month ]
    Inflammation markers

  73. Tumour Necrosis Factor alpha (TNF alpha) [ Time Frame: at day 0 ]
    Inflammation markers

  74. Tumour Necrosis Factor alpha (TNF alpha) [ Time Frame: at day 2 ]
    Inflammation markers

  75. Tumour Necrosis Factor alpha (TNF alpha) [ Time Frame: at day 5 ]
    Inflammation markers

  76. Tumour Necrosis Factor alpha (TNF alpha) [ Time Frame: at one month ]
    Inflammation markers

  77. Tissue Growth Factor Beta (TGF beta) [ Time Frame: at day 0 ]
    Fibrosis markers

  78. Tissue Growth Factor Beta (TGF beta) [ Time Frame: at day 2 ]
    Fibrosis markers

  79. Tissue Growth Factor Beta (TGF beta) [ Time Frame: at day 5 ]
    Fibrosis markers

  80. Tissue Growth Factor Beta (TGF beta) [ Time Frame: at one month ]
    Fibrosis markers

  81. Galectin 3 [ Time Frame: at day 0 ]
    Fibrosis markers

  82. Galectin 3 [ Time Frame: at day 2 ]
    Fibrosis markers

  83. Galectin 3 [ Time Frame: at day 5 ]
    Fibrosis markers

  84. Galectin 3 [ Time Frame: at one month ]
    Fibrosis markers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age greater than or equal to 18 years
  • Recent caustic product ingestion (time between taking the product and initiating the evaluated treatment or placebo between 6 and 24 hours after ingestion)
  • Predictive CT criteria for high-risk esophageal stenosis (grade IIb) in its most pathological part
  • Written, signed consent (trusted person if necessary, in case of impossibility of collection)
  • Beneficiary of a social security system

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760354


Contacts
Layout table for location contacts
Contact: Helene CORTE 01.42.49.49.49 helene.corte@aphp.fr
Contact: Marie-Quitterie PICAT 01.42.49.97.42 marie-quitterie.picat@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03760354     History of Changes
Other Study ID Numbers: P160803-J
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Caustic
Esophageal Stenosis
Pharyngeal Stenosis
Corticosteroid treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Esophageal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents