Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management

NCT ID: NCT03760354

Last Updated: 2018-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2023-02-15

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.

Conditions

Caustic Esophageal Injury; Esophageal Stenosis; Pharyngeal Stenosis

Keywords

Caustic; Esophageal Stenosis; Pharyngeal Stenosis; Corticosteroid treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days

Interventions

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

Intervention Type: DRUG

Placebo

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: OTHER

Other Intervention Names

Corticosteroid treatment; Control Arm

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Helene CORTE

Role: CONTACT

Phone: 01.42.49.49.49

Email: helene.corte@aphp.fr

Marie-Quitterie PICAT

Role: CONTACT

Phone: 01.42.49.97.42

Email: marie-quitterie.picat@aphp.fr

Other Identifiers

P160803-J

Identifier Type: -

Identifier Source: org_study_id