NCT03760354: CORTICAU

Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management

Status unknown Phase 2 Last updated 30 November 2018

What this trial tests

Phase 2 trial testing Methylprednisolone in Caustic Esophageal Injury in 30 participants. Status unknown.

Timeline

15 February 2019

Primary endpoint
15 February 2020

15 February 2023

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	15 February 2019
Primary completion	15 February 2020
Estimated completion	15 February 2023

Drugs / interventions tested

• Methylprednisolone (methylprednisolone) — full drug profile →
• Placebo

Conditions studied

• Caustic Esophageal Injury — all drugs for Caustic Esophageal Injury →
• Esophageal Stenosis — all drugs for Esophageal Stenosis →
• Pharyngeal Stenosis — all drugs for Pharyngeal Stenosis →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Caustic Esophageal Injury or Esophageal Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.