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

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

Interventions

DIAGNOSTIC_TEST

bowel ultrasound

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.

DIAGNOSTIC_TEST

colonoscopy

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.

Sponsors & Collaborators

• IRCCS San Raffaele

  lead OTHER

Principal Investigators

• MARIANGELA ALLOCCA · IRCCS San Raffaele

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-03

Primary Completion

2023-06-30

Completion

2025-01-31

Countries

• Italy

Study Locations