Pediatric Penetrating Crohn's Disease

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University Hospital, Montpellier

合作者

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

临床试验: NCT04119635

BioSeek: NCT04119635

关键词

抽象

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.

描述

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.

日期

最后验证:	09/30/2019
首次提交:	10/01/2019
提交的预估入学人数:	10/06/2019
首次发布:	10/07/2019
上次提交的更新:	10/06/2019
最近更新发布:	10/07/2019
实际学习开始日期:	08/31/2017
预计主要完成日期:	08/31/2018
预计完成日期:	09/29/2018

状况或疾病

Pediatric Penetrating Crohn's Disease

相

资格标准

有资格学习的性别	All
取样方式	Non-Probability Sample
接受健康志愿者	是
标准	Inclusion criteria: - patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon) before the age of 18.. 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.

结果

主要结果指标

1. incidence of intestinal resection performed for B3 complication in pediatric population [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.

次要成果指标

1. incidence of recurrence of B3 complication in pediatric population [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 [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"

Pediatric Penetrating Crohn's Disease

关键词

peritonitis

cellulitis

abscess

inflammation

fever

fistula

colitis

抽象

描述

日期

状况或疾病

相

资格标准

结果

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