Status:
UNKNOWN
Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Caustic Esophageal Injury
Esophageal Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03760354
Start Date
February 15 2019
End Date
February 15 2023
Last Update
November 30 2018
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