Exploring Ultrasound Innovations for Predicting Treatment Success in Severe Ulcerative Colitis

Is ADvanced transPerineaL UltraSonography in ulcerative colitis useful for predicting the response to induction therapy? (ADPLUS study) - ADPLUS study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053593

Enrollment

Registered

2024-02-10

Start date

2024-01-15

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants: Patients with ulcerative colitis (UC) in remission and active phases Implementation Timing: For patients in remission, at the time of endoscopy; for patients in the active phase, at the start of induction therapy, then 2 weeks, 14 weeks, and 24 weeks after

Exclusion criteria

Exclusion criteria: -Patients who have undergone colectomy -Pregnant patients -Among patients with active disease undergoing remission induction therapy, patients receiving remission induction therapy for extraintestinal complications rather than intestinal inflammation

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: Predictor: Remission at 24 weeks (defined as meeting all criteria for clinical remission, endoscopic improvement, and histological improvement) Definitions of Remission and Improvement: Endoscopic mucosal healing: Mayo endoscopic subscore=0 Endoscopic improvement: Mayo endoscopic subscore<2 Clinical remission: Defined as no rectal bleeding (PRO2 subscore=0) and a total PRO2<2 Ultrasound remission: Normal total colonic wall thickness and blood flow score<2 Histological mucosal improvement: Nancy index<=1, Geboes score<3.1 Evaluation of the degree of fibrosis: Improvement in urgency: Improvement of NRS>1 Disease clearance: clinical (partial-Mayo score<3), endoscopic (endoscopic-Mayo score=0), and histological (Nancy index=0)	—

Measure

Time frame

Primary Endpoint: Predictor: Remission at 24 weeks (defined as meeting all criteria for clinical remission, endoscopic improvement, and histological improvement) Definitions of Remission and Improvement: Endoscopic mucosal healing: Mayo endoscopic subscore=0 Endoscopic improvement: Mayo endoscopic subscore<2 Clinical remission: Defined as no rectal bleeding (PRO2 subscore=0) and a total PRO2<2 Ultrasound remission: Normal total colonic wall thickness and blood flow score<2 Histological mucosal improvement: Nancy index<=1, Geboes score<3.1 Evaluation of the degree of fibrosis: Improvement in urgency: Improvement of NRS>1 Disease clearance: clinical (partial-Mayo score<3), endoscopic (endoscopic-Mayo score=0), and histological (Nancy index=0)

—

Secondary

Measure	Time frame
Secondary Endpoints: Endoscopic mucosal healing and improvement at 24 weeks Clinical remission after 2 weeks, 14 weeks, and 24 weeks Ultrasound remission after 24 weeks Histological mucosal healing at 24 weeks: Nancy index <2 Correlation between endoscopic findings, urgency, and incontinence scores at baseline, after 2 weeks, 14 weeks, and 24 weeks	—

Countries

Japan

Contacts

Public ContactShintaro Sagami

Kitasato University Kitasato Institute Hospital Center for Advanced IBD Research and Treatment

jaken1013@gmail.com03-3444-6161

Outcome results