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NCT Number: NCT04119635

Pediatric Penetrating Crohn's Disease

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.

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Key information

Conditions

Pediatric Penetrating Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon)

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. incidence of recurrence of B3 complication in pediatric population

    Time frame: through study completion, an average of 10 years

    Incidence of recurrence of B3 complication and specifying :

    • median duration of recurrence after the first episode
    • number of recurrence

  2. 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.

    Multivariate analysis with the following data to define parameters associated with "recurrence of B3" or "intestinal resection"

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Adult gastroenterology service, Montpellier University Hospital: Dr Pineton de Chambrun
  • EPIMAD Registry: Dr Gower-Rousseau
  • Pediatric gastroenterology service, Montpellier University Hospital: Dr Kollen
  • Pediatric gastroenterology service, Toulouse University Hospital: Dr Breton

Registry information

Official study title

Treatment and Long-term Outcomes of Pediatric Patient With Penetrating Crohn's Disease: the Multicenter Cross-sectional Study

Acronym: Pediatric B3

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 8, 2019
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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