跳至主要内容
临床试验/NCT05735665
NCT05735665招募中不适用

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

IRCCS San Raffaele2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
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.

研究概览

简要总结

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.

详细描述

Prospective interventional randomized open-label study to validate the role of US-based treat-to-target strategies in the decision-making process in patients with UC.

Patients seen at each participating center who are eligible for this study will be randomized 1:1 (computer generated randomization list) to enter one of two study arms up to Week 52:

  1. study group: the bowel US-based treat to target arm
  2. control group: the routine CS treat to target arm. At Week 52 ± 4, all patients in the two study arms will undergo CS, bowel US, PRO and FC as indicated for the screening phase.

Patients will be followed up and will undergo the study procedures as described below:

Bowel Ultrasound-based Treat to target arm At W12 ± 4 and W24 ± 4, subjects will perform FC and bowel US and PRO will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Established diagnosis of UC since at least 8 weeks prior to inclusion
  • 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

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: 2 years

Remission will be defined as global Mayo Score at week 52

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariangela Allocca

Gastroenterologist

IRCCS San Raffaele

研究点 (2)

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