MedTrace Logo

Comparing TRIple Rectal Ultrasound Imaging Technology in Ulcerative Colitis

NCT06717906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-07-17

No results posted yet for this study

Summary

This study aims to evaluate the correlation of rectal wall thickness and vascularity measurements using trans-abdominal ultrasound (TAS), trans-perineal ultrasound (TPUS), and endoscopic ultrasound (EUS) in adult patients with ulcerative colitis (UC). The primary objective is to correlate rectal total wall thickness measured by TPUS with EUS, while secondary objectives include correlating rectal wall thickness and vascularity as measured by TAS, TPUS, and EUS, with endoscopic and histologic activity. Additionally, the study will assess changes in patient management following EUS/sigmoidoscopy compared to TAS/TPUS alone. Consecutive UC patients attending an IBD clinic will undergo clinical assessment using the Simple Clinical Colitis Activity Index (SCCAI) followed by TAS and TPUS as point-of-care tests. If clinically indicated, patients will also undergo sigmoidoscopy and EUS during the same visit, with measurements compared and correlated to histologic inflammation and fecal calprotectin (FCP) levels when available. This cross-sectional study will include a follow-up period until biopsy results are obtained, with a recruitment duration of 6-12 months and a target sample size of 170 patients (60 patients with mid-end ultrasound machine, rest with high-end ultrasound machine for transabdominal and transperineal ultrasound).

Conditions

Interventions

DIAGNOSTIC_TEST

Endoscopic Ultrasound

If sigmoidoscopy is warranted as per clinical indication, the consenting patients shall undergo endoscopic ultrasound (EUS) using a radial echo-endoscope during the same sitting of sigmoidoscopy without incurring any additional cost to the patient. Total rectal wall thickness in anterior and posterior wall shall be measured in upper, middle and lower rectum with assessment of vascularity (Modified Limberg scale). The maximal wall thickness including maximum mucosal and submucosal thickness shall be noted and compared to total wall thickness measured by transabdominal ultrasound (TAS) and Transperineal ultrasound (TPUS). On sigmoidoscopy, rectal inflammation shall be measured by ulcerative colitis endoscopic index of severity (UCEIS) in rectum. Biopsy seal be taken as standard protocol to document histologic inflammation (measured by Nancy histologic index) which is known to predict future risk of relapse.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-27
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06717906 on ClinicalTrials.gov