Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis

Acute Severe Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324500
• Other study ID #: ASC-US
• Status: Recruiting
• Start date: March 2, 2020
• Est. completion date: May 2, 2025

Study information

• Verified date: March 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Paolo Lionetti
• Phone: 3398416059
• Email: paolo.lionetti[@]meyer.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2, 2025
• Est. primary completion date: March 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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;

Related Conditions & MeSH terms

• Acute Severe Colitis
• Colitis

Locations

Country	Name	City	State
Italy	Ospedale Maggiore	Bologna
Italy	Meyer Children's Hospital IRCCS	Florence	Firenze
Italy	IRCCS Materno Infantile Burlo Garofolo	Trieste
Spain	CMED Centro Médico-Quirúrgico de Enfermedades Digestivas	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment	Investigation of the ability of BUS (bowel ultrasound) parameters, such as Colonic wall thickness (CWT) measured in mm, assessed within 48 hours from i.v. steroid treatment initiation, to predict the failure of first line treatment (defined according to the latest ESPGHAN guidelines).; CWT will be measured from the edge of the outer wall to the inner echogenic lumen, containing air, or to the central echogenic mucosal stripe. CWT will be assessed as follows: two measurement through longitudinal plain and two through tranverse plain will be performed and the mean value (the sum of each measurement divided for 4) will be taken into account	Within 48 hours from i.v. steroid treatment initiation
Primary	Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment	Colonic wall vascularization will be assessed according to the Limberg score to identify two subgroups: 1) increased vascularization (Limberg score 3-4); 2) normal colonic wall flow (Limberg Score 0-2). Such classification will be used, measured within the first 48 hours from i.v. steroid initiation, to predict failure of first line treatment (according to the latest ESPGHAN guidelines)	Within 48 hours from i.v. steroid treatment initiation
Primary	Mesenteric lymph nodes BUS (bowel ultrasound) parameter	Presence of enlarged mesenteric lymph nodes, defined by short axis > 5 mm it will be assessed within 48 hours from i.v. steroid treatment initiation, to predict the failure of first line treatment (defined according to the latest ESPGHAN guidelines)	Within 48 hours from i.v. steroid treatment initiation
Secondary	evaluation of the prognostic value of the ultrasound parameters	evaluation of the prognostic value of the ultrasound parameters in predicting the possible failure of second-line therapy and therefore the need to carry out colectomy surgery	Within 48 hours from second-line therapy initiation