Clinical trial NCT06324500: Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis
Official title: Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis (ASC): A Prospective Multicenter Study From the Paediatric IBD Porto Group of ESPGHAN
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Severe Colitis
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged \< 18 years hospitalized for ASC with diagnosis of UC established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria

Brief summary: ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC.

BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC.


Eligibility criteria: Inclusion Criteria:

* Patients aged \< 18 years hospitalized for ASC with diagnosis of UC established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria

Exclusion Criteria:

* Patients with infectious colitis;
* Patients undergoing treatment with anti-TNF alpha agents;
* Patients already enrolled during the study period for a previous ASC attack;

Primary outcomes:
measure: Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment
timeFrame: Within 48 hours from i.v. steroid treatment initiation
measure: Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment
timeFrame: Within 48 hours from i.v. steroid treatment initiation
measure: Mesenteric lymph nodes BUS (bowel ultrasound) parameter
timeFrame: Within 48 hours from i.v. steroid treatment initiation
Secondary outcomes:
measure: evaluation of the prognostic value of the ultrasound parameters
timeFrame: Within 48 hours from second-line therapy initiation
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
state: Firenze
city: Bologna
country: Italy
facility: Ospedale Maggiore
city: Trieste
country: Italy
facility: IRCCS Materno Infantile Burlo Garofolo
city: Madrid
country: Spain
facility: CMED Centro Médico-Quirúrgico de Enfermedades Digestivas
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Paolo Lionetti, MD
role: PRINCIPAL_INVESTIGATOR
References: