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

NCT06324500 | Recruiting

• 1 other identifier: ASC-US
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 4

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.

Conditions

Acute Severe Colitis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• evaluation of the prognostic value of the ultrasound parameters

  Within 48 hours from second-line therapy initiation

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (4)

Meyer Children's Hospital IRCCS

Florence, Firenze, 50139, Italy

RECRUITING

Ospedale Maggiore

Bologna, Italy

RECRUITING

IRCCS Materno Infantile Burlo Garofolo

Trieste, Italy

RECRUITING

CMED Centro Médico-Quirúrgico de Enfermedades Digestivas

Madrid, Spain

RECRUITING

Study Officials

• Paolo Lionetti, MD

  Meyer Children's Hospital IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Lionetti

CONTACT

3398416059; paolo.lionetti@meyer.it

Luca Scarallo

CONTACT

3928166681; luca.scarallo@meyer.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Head of Gastroenterology, Principal Investigator

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 22, 2024
• Study Start: March 2, 2020
• Primary Completion: March 2, 2025
• Study Completion: May 2, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (3)