Caustic Esophageal InjuryPhase 2CORTICAUNCT03760354
Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management
A Phase 2 study testing Methylprednisolone in people with Caustic Esophageal Injury and Esophageal Stenosis, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caustic Esophageal Injury, Esophageal Stenosis, Pharyngeal Stenosis
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2019to 15 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Being tested
- Methylprednisolone, Placebo
- Keywords
- Caustic, Esophageal Stenosis, Pharyngeal Stenosis, Corticosteroid treatment
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Corticosteroid treatment
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
PlaceboOther
Also called Control Arm
NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indication for esophageal or pharyngeal surgical reconstruction
The primary outcome is the indication for esophageal or pharyngeal surgical reconstruction due to:
- 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.
- The occurrence of pharyngeal stenosis, defined by the need to perform pharyngoplasty.
Measured: within 12 months post ingestion
Secondary outcomes (84)
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
Measured: at 1 month
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
Measured: at 3 months
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
Measured: at 6 months
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
Measured: at 9 months
Delay in the occurrence of refractory esophagal stenosis or pharyngeal stenosis
Time between inclusion and occurrence of refractory stenosis or pharyngeal stenosis
Measured: at 12 months
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Measured: at 1 month
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Measured: at 3 months
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Measured: at 6 months
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Measured: at 9 months
Distance of the stenosis
Distance between the stenosis and the dental arches (cm)
Measured: at 12 months
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Measured: at 1 month
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Measured: at 3 months
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Measured: at 6 months
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Measured: at 9 months
Number of stenosis
Number of stenosis will be evaluated by endoscopy
Measured: at 12 months
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Measured: at 1 month
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Measured: at 3 months
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Measured: at 6 months
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Measured: at 9 months
Length of stenosis
Length of each stenosis will be evaluated by endoscopy
Measured: at 12 months
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Measured: at 1 month
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Measured: at 3 months
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Measured: at 6 months
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Measured: at 9 months
Estimated diameter of stenosis
Diameter of each stenosis will be evaluated by endoscopy
Measured: at 12 months
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Measured: at 1 month
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Measured: at 3 months
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Measured: at 6 months
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Measured: at 9 months
Endoluminal inflammation
Importance of endoluminal inflammation during endoscopy performed for dilation (minimal, moderate, or severe)
Measured: at 12 months
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Measured: at 1 month
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Measured: at 3 months
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Measured: at 6 months
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Measured: at 9 months
Number of dilation sessions
Number of dilation sessions evaluated by endoscopy
Measured: at 12 months
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Measured: at 1 month
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Measured: at 3 months
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Measured: at 6 months
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Measured: at 9 months
Intervals between iterative dilations
Time between endoscopic dilatations if necessary iterative dilation
Measured: at 12 months
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Measured: at 1 month
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Measured: at 3 months
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Measured: at 6 months
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Measured: at 9 months
Digestive perforations
Proportion of digestive perforations secondary to endoscopic dilation
Measured: at 12 months
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Measured: at 1 month
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Measured: at 3 months
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Measured: at 6 months
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Measured: at 9 months
Extent of pharyngeal stenosis
Laryngeal stenosis associated with pharyngeal stenosis
Measured: at 12 months
Proportion of unanticipated adverse reactions
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
Measured: at day 0
Proportion of unanticipated adverse reactions
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
Measured: at day 2
Proportion of unanticipated adverse reactions
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
Measured: at day 5
Proportion of unanticipated adverse reactions
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
Measured: at day 7
Proportion of unanticipated adverse reactions
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
Measured: at one month
Proportion of unanticipated adverse reactions
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
Measured: at 3 months
Proportion of unanticipated adverse reactions
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
Measured: at 6 months
Proportion of unanticipated adverse reactions
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
Measured: at 9 months
Proportion of unanticipated adverse reactions
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
Measured: at 12 months
Proportion of adverse reactions related to corticosteroid therapy
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)
Measured: within 7 days
C-Reactive Protein (CRP)
Inflammation markers
Measured: at day 0
C-Reactive Protein (CRP)
Inflammation markers
Measured: at day 2
C-Reactive Protein (CRP)
Inflammation markers
Measured: at day 5
C-Reactive Protein (CRP)
Inflammation markers
Measured: at one month
interleukin-1 (IL1)
Inflammation markers
Measured: at day 0
interleukin-1 (IL1)
Inflammation markers
Measured: at day 2
interleukin-1 (IL1)
Inflammation markers
Measured: at day 5
interleukin-1 (IL1)
Inflammation markers
Measured: at one month
interleukin-6 (IL-6)
Inflammation markers
Measured: at day 0
interleukin-6 (IL-6)
Inflammation markers
Measured: at day 2
interleukin-6 (IL-6)
Inflammation markers
Measured: at day 5
interleukin-6 (IL-6)
Inflammation markers
Measured: at one month
Tumour Necrosis Factor alpha (TNF alpha)
Inflammation markers
Measured: at day 0
Tumour Necrosis Factor alpha (TNF alpha)
Inflammation markers
Measured: at day 2
Tumour Necrosis Factor alpha (TNF alpha)
Inflammation markers
Measured: at day 5
Tumour Necrosis Factor alpha (TNF alpha)
Inflammation markers
Measured: at one month
Tissue Growth Factor Beta (TGF beta)
Fibrosis markers
Measured: at day 0
Tissue Growth Factor Beta (TGF beta)
Fibrosis markers
Measured: at day 2
Tissue Growth Factor Beta (TGF beta)
Fibrosis markers
Measured: at day 5
Tissue Growth Factor Beta (TGF beta)
Fibrosis markers
Measured: at one month
Galectin 3
Fibrosis markers
Measured: at day 0
Galectin 3
Fibrosis markers
Measured: at day 2
Galectin 3
Fibrosis markers
Measured: at day 5
Galectin 3
Fibrosis markers
Measured: at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start15 Feb 2019 (estimated)
- Primary completion15 Feb 2020 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caustic Esophageal InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Phase II, Bayesian, single-blinded, monocentric, randomized, prospective clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760354
- Sponsor's protocol ID
- P160803-J
- Acronym
- CORTICAU
- Status last verified
- Nov 2018
- First submitted
- 28 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03760354
- Acronym / sponsor ID
- CORTICAU / P160803-J
- Keywords
- Caustic, Esophageal Stenosis, Pharyngeal Stenosis, Corticosteroid treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective Phase II, Bayesian, single-blinded, monocentric, randomized, prospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: MethylprednisoloneDose: 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) | Placebo comparator | Other: PlaceboNaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneAlso: Corticosteroid treatmentDose: 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 |
| PlaceboAlso: Control ArmNaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days | Other | Placebo (no corticosteroid treatment) |
Primary outcome
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.
84 secondary outcomes
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time frame: at 1 month
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time frame: at 3 months
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time frame: at 6 months
Delay in the occurrence of refractory stenosis or pharyngeal stenosis
Time frame: at 9 months
Delay in the occurrence of refractory esophagal stenosis or pharyngeal stenosis
Time frame: at 12 months
Distance of the stenosis
Time frame: at 1 month
Distance of the stenosis
Time frame: at 3 months
Distance of the stenosis
Time frame: at 6 months
Distance of the stenosis
Time frame: at 9 months
Distance of the stenosis
Time frame: at 12 months
Number of stenosis
Time frame: at 1 month
Number of stenosis
Time frame: at 3 months
Number of stenosis
Time frame: at 6 months
Number of stenosis
Time frame: at 9 months
Number of stenosis
Time frame: at 12 months
Length of stenosis
Time frame: at 1 month
Length of stenosis
Time frame: at 3 months
Length of stenosis
Time frame: at 6 months
Length of stenosis
Time frame: at 9 months
Length of stenosis
Time frame: at 12 months
Estimated diameter of stenosis
Time frame: at 1 month
Estimated diameter of stenosis
Time frame: at 3 months
Estimated diameter of stenosis
Time frame: at 6 months
Estimated diameter of stenosis
Time frame: at 9 months
Estimated diameter of stenosis
Time frame: at 12 months
Endoluminal inflammation
Time frame: at 1 month
Endoluminal inflammation
Time frame: at 3 months
Endoluminal inflammation
Time frame: at 6 months
Endoluminal inflammation
Time frame: at 9 months
Endoluminal inflammation
Time frame: at 12 months
Number of dilation sessions
Time frame: at 1 month
Number of dilation sessions
Time frame: at 3 months
Number of dilation sessions
Time frame: at 6 months
Number of dilation sessions
Time frame: at 9 months
Number of dilation sessions
Time frame: at 12 months
Intervals between iterative dilations
Time frame: at 1 month
Intervals between iterative dilations
Time frame: at 3 months
Intervals between iterative dilations
Time frame: at 6 months
Intervals between iterative dilations
Time frame: at 9 months
Intervals between iterative dilations
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Caustic Esophageal Injury
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Esophageal Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylprednisolone in people with Caustic Esophageal Injury and Esophageal Stenosis, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helene CORTE (01.42.49.49.49, helene.corte@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indication for esophageal or pharyngeal surgical reconstruction (time frame: within 12 months post ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.