The added value of frequent intestinal ultrasonography in the close monitoring of moderate-severe ulcerative colitis

The added value of frequent intestinal ultrasonography in the close monitoring of moderate-severe ulcerative colitis - Intestinal ultrasonography in modeate/severe ulcerative colitis/DIRECT-UC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49013

Enrollment

Registered

2019-04-25

Start date

2019-07-26

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis: inflammatory bowel (colon) disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Ulcerative colitis, histologically and endoscopically confirmed *Endoscopically moderate to severe disease with a eMayo score *2 *Start of medical treatment *>18 years of age

Exclusion criteria

Exclusion criteria: *Age35 kg/m²) *A normal bowel wall

Design outcomes

Primary

Measure	Time frame
The main endpoint of this study will be difference in change of bowel wall width within 26 weeks between the responding and non-responding group.	—

Secondary

Measure	Time frame
Ultrasonographic endpoints at week 0, 1, 2, 6 and between week 8 and 26: Lumen width (millimetres) Bowel wall thickness measured from the hyperechoic lumen to the hypoechoic muscularis propra (millimetres) Loss of stratification of the colon wall (yes/no) Layer thickness (mucosa, submucosa, muscularis propria in millimetres) Colon wall perfusion following the Limberg score Disease extent (areas affected) Loss of haustrae (yes/no) Mesenteric lymph nodes (yes/no) Abscesses (yes/no) Examination time (minutes) Visibility (0-3 point scale) Faecal calprotectin Remission 3 but 45 mg/mL Endoscopic disease activity Response (UCEIS): decrease of 2 points in UCEIS at follow-up endoscopy at 8 to 26 weeks. Remission (UCEIS): UCEIS * 1 Remission (Mayo): Mayo * 1 Other study parameters Steroid refractory rate within 26 weeks Infliximab trough levels at week 2 and 6 Colectomy rate within 26 weeks	—

Measure

Time frame

Ultrasonographic endpoints at week 0, 1, 2, 6 and between week 8 and 26: Lumen width (millimetres) Bowel wall thickness measured from the hyperechoic lumen to the hypoechoic muscularis propra (millimetres) Loss of stratification of the colon wall (yes/no) Layer thickness (mucosa, submucosa, muscularis propria in millimetres) Colon wall perfusion following the Limberg score Disease extent (areas affected) Loss of haustrae (yes/no) Mesenteric lymph nodes (yes/no) Abscesses (yes/no) Examination time (minutes) Visibility (0-3 point scale) Faecal calprotectin Remission 3 but 45 mg/mL Endoscopic disease activity Response (UCEIS): decrease of 2 points in UCEIS at follow-up endoscopy at 8 to 26 weeks. Remission (UCEIS): UCEIS * 1 Remission (Mayo): Mayo * 1 Other study parameters Steroid refractory rate within 26 weeks Infliximab trough levels at week 2 and 6 Colectomy rate within 26 weeks

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Countries

Netherlands

Outcome results