Pediatric Penetrating Crohn's DiseasePediatric B3NCT04119635
Pediatric Penetrating Crohn's Disease
An observational study of Pediatric Penetrating Crohn's Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The incidence of Crohn's disease (CD) increased the last few years, especially in children, with 20% percent of CD patients diagnosed during childhood. The CD is a chronic disease without curative treatment, medical or surgical, and evolution is longer in children, avoid iterative digestive resections and their… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Penetrating Crohn's Disease
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 30 Sep 2018
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon) before the age of 18
Who may be able to join
- patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon)
Who cannot join
- patient having isolated perineal disease, indeterminate colitis or with too much missing data were excluded
- patients refuse the use of medical data will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment and Long-term Outcomes of Pediatric Patient With Penetrating Crohn's Disease: the Multicenter Cross-sectional Study
The incidence of Crohn's disease (CD) increased the last few years, especially in children, with 20% percent of CD patients diagnosed during childhood. The CD is a chronic disease without curative treatment, medical or surgical, and evolution is longer in children, avoid iterative digestive resections and their consequences in these patients is a major issue.
The beginning of the disease at pediatric age is considered to be a poor prognostic factor and is considered to be more aggressive than that of adults: more extensive, more active and requiring more immunosuppressive treatments, with a more frequent dependence on corticosteroids and a shorter delay between the beginning of symptoms and the first surgery. After 5 years of evolution, 13 to 50% of patients with early pediatric MC have undergone intestinal resection.
Read more
The Paris' classification defined 3 phenotypes or behaviors in pediatric Crohn's disease. Penetrating phenotype (B3) is a heterogeneous group defined by the presence of intra-abdominal perforation, fistulas or abscesses. The B3 phenotype is a risk factor for pejorative evolution in CD with a risk increased of surgical resection.
In the pediatric population, the natural history of patients with penetrating CD is unknown. Most studies focus on CD beginning at pediatric age but with penetrating complications occurring in adulthood or pediatric penetrating CD but with relatively short follow-up. The risk of recurrence of the penetrating disease after a first complication in childhood is unknown, the factors influencing this risk also. And, there is no consensus either concerning optimal B3 management in children, and the practices are variable from specialist to specialist.
After describing the pediatric population with penetrating CD, the aim of this study was to know the incidence of bowel resection for B3 episode. The secondary aims were to describe the immediate management and long-term evolution of these patients and to identify risk factors for adverse evolution.
Read the detailed description
This study is cross-sectional and is carrying out between 1995 and 2017 in two French tertiary referral centers (Montpellier, Toulouse) and EPIMAD registry which is currently the largest Inflammatory Bowel Disease cohort in world and cover 9.6% of French population (Nord, Pas-de-Calais, Somme, and Seine-Maritime department).
All patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon) before the age of 18. Patient having isolated perineal disease, indeterminate colitis or with too much missing data were excluded.
The main endpoint: incidence of intestinal resection performed for B3 complication.
The secondary endpoints:
- description of the pediatric population with B3 complication with:
- demographic data: sex, family history, phenotype of the disease according to the Paris classification, age at diagnosis of B3, period of diagnosis of B3 (before or after 2001), time between the diagnosis of CD and the diagnosis of B3, a history of medical and surgical treatment for CD received before B3.
- clinical data: type of B3 complication, presence of stenosis and its location, clinical symptoms (fever, obstructive symptoms), nutritional status.
- description of the immediate management of these patients, specifying: the place of care, the type of immediate management performed, the drug treatments received in the acute phase, the medical treatments for CD introduced for the B3 episode, the intestinal resections performed for the B3 episode, the realization of a stoma, the radiological drainage of abscesses, the immediate complications of B3.
- description of the long-term evolution of these patients, specifying: the given drug treatments, the clinical recurrence of the CD, the recurrence of B3, the need for intestinal resection during follow-up, the occurrence of other events
- identification of risk factors for pejorative evolution defined by "recurrence of B3" or "intestinal resection" in these patients.
- Conditions
- Pediatric Penetrating Crohn's Disease
- Keywords
- Crohn's disease, Penetrating complication, Pediatric, Inflammatory bowel disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intestinal resection performed for B3 complication in pediatric population
- Incidence of intestinal resection at the first episode of B3
- Cumulated incidence of intestinal resection in the follow up.
Measured: through study completion, an average of 10 years
Secondary outcomes (2)
incidence of recurrence of B3 complication in pediatric population
Incidence of recurrence of B3 complication and specifying :
- median duration of recurrence after the first episode
- number of recurrence
Measured: through study completion, an average of 10 years
identification of risk factors for pejorative evolution (recurrence of <B3 or intestinal resection) of the pediatric population with B3 complication
Multivariate analysis with the following data to define parameters associated with "recurrence of B3" or "intestinal resection"
Measured: through study completion, an average of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Sep 2017
- Primary completion1 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Penetrating Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric gastroenterology service, Toulouse University Hospital: Dr Breton, Adult gastroenterology service, Montpellier University Hospital: Dr Pineton de Chambrun, Pediatric gastroenterology service, Montpellier University Hospital: Dr Kollen, EPIMAD Registry: Dr Gower-Rousseau
- Responsible party
- Sponsor
- Investigators
- Laura Kollen, MD, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119635
- Sponsor's protocol ID
- RECHMPL19_0366
- Acronym
- Pediatric B3
- Status last verified
- Dec 2020
- First submitted
- 2 Oct 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Long-term Outcomes of Pediatric Patient With Penetrating Crohn's Disease: the Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04119635
- Acronym / sponsor ID
- Pediatric B3 / RECHMPL19_0366
- Conditions
- Pediatric Penetrating Crohn's Disease
- Keywords
- Crohn's disease, Penetrating complication, Pediatric, Inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Pediatric gastroenterology service, Toulouse University Hospital: Dr Breton, Adult gastroenterology service, Montpellier University Hospital: Dr Pineton de Chambrun, Pediatric gastroenterology service, Montpellier University Hospital: Dr Kollen, EPIMAD Registry: Dr Gower-Rousseau
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 8 Oct 2019 (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 incidence of Crohn's disease (CD) increased the last few years, especially in children, with 20% percent of CD patients diagnosed during childhood. The CD is a chronic disease without curative treatment, medical or surgical, and evolution is longer in children, avoid iterative digestive resections and their consequences in these patients is a major issue.
The beginning of the disease at pediatric age is considered to be a poor prognostic factor and is considered to be more aggressive than that of adults: more extensive, more active and requiring more immunosuppressive treatments, with a more frequent dependence on corticosteroids and a shorter delay between the beginning of symptoms and the first surgery. After 5 years of evolution, 13 to 50% of patients with early pediatric MC have undergone intestinal resection.
The Paris' classification defined 3 phenotypes or behaviors in pediatric Crohn's disease. Penetrating phenotype (B3) is a heterogeneous group defined by the presence of intra-abdominal perforation, fistulas or abscesses. The B3 phenotype is a risk factor for pejorative evolution in CD with a risk increased of surgical resection.
In the pediatric population, the natural history of patients with penetrating CD is unknown. Most studies focus on CD beginning at pediatric age but with penetrating complications occurring in adulthood or pediatric penetrating CD but with relatively short follow-up. The risk of recurrence of the penetrating disease after a first complication in childhood is unknown, the factors influencing this risk also. And, there is no consensus either concerning optimal B3 management in children, and the practices are variable from specialist to specialist.
After describing the pediatric population with penetrating CD, the aim of this study was to know the incidence of bowel resection for B3 episode. The secondary aims were to describe the immediate management and long-term evolution of these patients and to identify risk factors for adverse evolution.
Detailed description
This study is cross-sectional and is carrying out between 1995 and 2017 in two French tertiary referral centers (Montpellier, Toulouse) and EPIMAD registry which is currently the largest Inflammatory Bowel Disease cohort in world and cover 9.6% of French population (Nord, Pas-de-Calais, Somme, and Seine-Maritime department).
All patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon) before the age of 18. Patient having isolated perineal disease, indeterminate colitis or with too much missing data were excluded.
The main endpoint: incidence of intestinal resection performed for B3 complication.
The secondary endpoints:
- description of the pediatric population with B3 complication with:
- demographic data: sex, family history, phenotype of the disease according to the Paris classification, age at diagnosis of B3, period of diagnosis of B3 (before or after 2001), time between the diagnosis of CD and the diagnosis of B3, a history of medical and surgical treatment for CD received before B3.
- clinical data: type of B3 complication, presence of stenosis and its location, clinical symptoms (fever, obstructive symptoms), nutritional status.
- description of the immediate management of these patients, specifying: the place of care, the type of immediate management performed, the drug treatments received in the acute phase, the medical treatments for CD introduced for the B3 episode, the intestinal resections performed for the B3 episode, the realization of a stoma, the radiological drainage of abscesses, the immediate complications of B3.
- description of the long-term evolution of these patients, specifying: the given drug treatments, the clinical recurrence of the CD, the recurrence of B3, the need for intestinal resection during follow-up, the occurrence of other events
- identification of risk factors for pejorative evolution defined by "recurrence of B3" or "intestinal resection" in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon) before the age of 18
Key inclusion criteria (1 listed)
- patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon)
Key exclusion criteria (2 listed)
- patient having isolated perineal disease, indeterminate colitis or with too much missing data were excluded
- patients refuse the use of medical data will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of intestinal resection performed for B3 complication in pediatric population
Time frame: through study completion, an average of 10 years
* Incidence of intestinal resection at the first episode of B3 * Cumulated incidence of intestinal resection in the follow up.
2 secondary outcomes
incidence of recurrence of B3 complication in pediatric population
Time frame: through study completion, an average of 10 years
identification of risk factors for pejorative evolution (recurrence of <B3 or intestinal resection) of the pediatric population with B3 complication
Time frame: through study completion, an average of 10 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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.
Laura Kollen, MD principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Penetrating Crohn's Disease, run by University Hospital, Montpellier at 1 site in France.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of intestinal resection performed for B3 complication in pediatric population (time frame: through study completion, an average of 10 years). 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 29 Dec 2020.