Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis

NCT05735665 | Unknown

• 1 other identifier: T2T
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

UC (UC) is a chronic, relapsing and destructive inflammatory disorder of the colon which can lead to organ damage and impair quality of life. Consensus guidelines recommend to go beyond resolution of clinical symptoms and achieve endoscopic remission. This long-term treatment goal in UC is commonly defined by a Mayo endoscopic subscore \< 13, and is associated with prolonged clinical remission, lower rates of hospitalization and lower rates of colectomy. However, colonoscopy is an invasive and expensive procedure, unpleasant to patients, not without risks, especially during severe flares. Moreover, CS is time-consuming and expensive for the Healthcare System. Clinical symptoms correlate well with endoscopic findings, and their improvement together to normalization of FC, are currently considered the short-term and intermediate-term targets to achieve. However, while asymptomatic patients with FC \< 50 mcg/g have \< 5% probability to have endoscopic lesions, and conversely patients with evident rectal bleeding and persistent increased stool frequency (\> 3 stools above baseline) with FC \> 250 mcg/g have less than 5% chance to have endoscopic remission, in patients in the intermediate scenarios with stool frequency score (SFS) 2 or 3 or rectal bleeding score (RBS) \> 0, with FC values between 50 and 250 mcg/g, the uncertainty increases and CS should not be avoided. Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice8. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process9. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria \[Milan ultrasound criteria (MUC)\] to assess and grade endoscopic activity in UC10,11. The investigators also confirmed that a MUC score \> 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore \> 1 Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria \[Milan ultrasound criteria (MUC)\] to assess and grade endoscopic activity in UC14,15. The investigators also confirmed that a MUC score \> 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore \> 1.

Conditions

Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe

Outcome Measures

Primary Outcomes (1)

• The primary objective is to evaluate the two strategies in terms of efficacy of bowel US-based strategy versus CS-based strategy in terms of remission.

  Remission will be defined as global Mayo Score at week 52

  2 years

Study Arms (2)

study group: the bowel Ultrasound-based treat to target arm

EXPERIMENTAL

At W12 ± 4 and W24 ± 4, subjects will perform FC and bowel US and PRO will be recorded. If rectal bleeding \> 2 + stool frequency \> 2 AND FC \> 250 mcg/g AND/OR MUC \> 6.2, treatment will be changed according to GCP and international guidelines.

Diagnostic Test: bowel ultrasound

control group: the routine Colonoscopy treat to target arm.

OTHER

At W12 ± 4 and W24 ± 4, subjects will perform FC and PRO will be recorded for all patients. If rectal bleeding \> 2 + stool frequency \> 2 AND FC \> 250 mcg/g, treatment will be changed according to GCP and international guidelines. If rectal bleeding \> 0 + stool frequency \> 2 AND FC will be ≥ 50 mcg/g and ≤ 250 mcg/g, a RSS will be done in order to decide any treatment switch.

Diagnostic Test: colonoscopy

Interventions

bowel ultrasound DIAGNOSTIC_TEST

Bowel US is a non-invasive tool which is able to measure intestinal inflammation by the use of emission of US from a specific probe. It is used externally, just moving the probe on the skin of the patient along the abdominal section. It does not require any contrast. The preparation used is just a fasting period of 6 hours.

study group: the bowel Ultrasound-based treat to target arm

colonoscopy DIAGNOSTIC_TEST

Colonoscopy is an endoscopic procedure where a tube is inserted from the anus up to the ileum of the patient. It requires bowel cleansing with polyethilenglicole up to 4 liters (depending on the preparation and the desired grade of cleansing) the day before the examination. Because it may be painful, usually sedation is provided.

control group: the routine Colonoscopy treat to target arm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Any gender/sex
• Active disease consistent with indication to start with systemic corticosteroids, biological agents or small molecules (defined as a patient-reported outcomes score, PRO \> 2)
• Ability to understand and to comply with the study procedure and sign an informed consent form

You may not qualify if:

• Subjects with inflammation restricted to the rectum (≤ 15 cm from the anal verge);
• Subjects with severe UC (defined as a Mayo global score \> 12, requiring hospitalization);
• Subjects with an endoscopic Mayo sub-score at baseline \<2;
• Subjects with a MUC at baseline \< 6.2;
• Pregnancy
• Subjects with any contraindication to any study procedure.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Mariangela Allocca

Milan, 20132, Italy

RECRUITING

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• MARIANGELA ALLOCCA

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARIANGELA ALLOCCA

CONTACT

02 2643 2069; allocca.mariangela@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 21, 2023
• Study Start: October 3, 2022
• Primary Completion: June 1, 2023
• Study Completion: January 1, 2025
• Last Updated: February 21, 2023

Record last verified: 2023-01

Locations

IT (1)