Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management

NCT03760354 | Unknown Phase 2

• 1 other identifier: P160803-J
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Indication for esophageal or pharyngeal surgical reconstruction

  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.

  within 12 months post ingestion

Secondary Outcomes (84)

• Delay in the occurrence of refractory stenosis or pharyngeal stenosis

  at 1 month

• Delay in the occurrence of refractory stenosis or pharyngeal stenosis

  at 3 months

• Delay in the occurrence of refractory stenosis or pharyngeal stenosis

  at 6 months

• Delay in the occurrence of refractory stenosis or pharyngeal stenosis

  at 9 months

• Delay in the occurrence of refractory esophagal stenosis or pharyngeal stenosis

  at 12 months

Study Arms (2)

Methylprednisolone

EXPERIMENTAL

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

Placebo (no corticosteroid treatment)

PLACEBO COMPARATOR

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

Interventions

Methylprednisolone 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

Also known as: Corticosteroid treatment

Methylprednisolone

Placebo OTHER

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

Also known as: Control Arm

Placebo (no corticosteroid treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Esophageal Stenosis

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Helene CORTE

CONTACT

01.42.49.49.49; helene.corte@aphp.fr

Marie-Quitterie PICAT

CONTACT

01.42.49.97.42; marie-quitterie.picat@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blinded trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Phase II, Bayesian, single-blinded, monocentric, randomized, prospective clinical trial

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 30, 2018
• Study Start: February 15, 2019
• Primary Completion: February 15, 2020
• Study Completion: February 15, 2023
• Last Updated: November 30, 2018

Record last verified: 2018-11