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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22303

Enrollment

Registered

2019-07-26

Start date

2019-07-26

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Ulcerative colitis, inflammatory bowel diseases

Interventions

Intestinal ultrasound

Eligibility

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: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Proctitis only • Colonic stricture at baseline endoscopy • Imminent need of surgery • Sigmoidoscopy/colonoscopy older than eight weeks • Ongoing gastroenteritis • Cytomegalovirus (CMV) associated colitis • Obesity (BMI >35 kg/m²) • A normal bowel wall < 2mm at baseline ultrasonography

Design outcomes

Primary

Measure	Time frame
The main endpoint of this study will be change in bowel wall width in millimetres within 0 to 26 weeks against the reference standard of endoscopy where response on endoscopy is defined as a decrease of at least 1 point in eMayo-score at follow-up endoscopy after 8 to 26 weeks.	—

Secondary

Measure	Time frame
• Change of other ultrasound parameters within 0 to 26 weeks against both eMayo and UCEIS at follow-up endoscopy between week 8 and 26 • Change of all ultrasound parameters within 0 to 26 weeks against clinical response according to clinical disease activity indices (Mayo, SCCAI) • Change of all ultrasound parameters within 0 to 26 weeks against biochemical parameters (blood and faecal parameters) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting response to treatment according to response on follow-up endoscopy between week 8 and 26 (eMayo, UCEIS) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting remission on follow-up endoscopy between week 8 and 26 (eMayo, UCEIS) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting response to treatment according to response based on clinical disease activity indices (Mayo, Lichtiger score) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting remission according to clinical disease activity indices (Mayo, SCCAI, Lichtiger score) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting response to treatment according to response based on biochemical parameters (faecal calprotectin, CRP) • Ultrasound parameters at baseline predicting deterioration in acute severe ulcerative colitis according to Oxford criteria • Ultrasound parameters at baseline, week 1, 2 and 6 predicting colectomy within 0 to 26 weeks. • Ultrasound parameters at baseline, week 1, 2 and 6 predicting failing steroid treatment	—

Measure

Time frame

• Change of other ultrasound parameters within 0 to 26 weeks against both eMayo and UCEIS at follow-up endoscopy between week 8 and 26 • Change of all ultrasound parameters within 0 to 26 weeks against clinical response according to clinical disease activity indices (Mayo, SCCAI) • Change of all ultrasound parameters within 0 to 26 weeks against biochemical parameters (blood and faecal parameters) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting response to treatment according to response on follow-up endoscopy between week 8 and 26 (eMayo, UCEIS) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting remission on follow-up endoscopy between week 8 and 26 (eMayo, UCEIS) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting response to treatment according to response based on clinical disease activity indices (Mayo, Lichtiger score) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting remission according to clinical disease activity indices (Mayo, SCCAI, Lichtiger score) • Ultrasound parameters at baseline, week 1, 2 and 6 predicting response to treatment according to response based on biochemical parameters (faecal calprotectin, CRP) • Ultrasound parameters at baseline predicting deterioration in acute severe ulcerative colitis according to Oxford criteria • Ultrasound parameters at baseline, week 1, 2 and 6 predicting colectomy within 0 to 26 weeks. • Ultrasound parameters at baseline, week 1, 2 and 6 predicting failing steroid treatment

—

Contacts

Public ContactFloris de Voogd

Amsterdam UMC/AMC

f.a.devoogd@amsterdamumc.nl020-5661922

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)