Comparing TRIple Rectal Ultrasound Imaging Technology in Ulcerative Colitis

NCT06717906 | Completed

• 1 other identifier: AGPL/TRINITY/01; Version:01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Compare diagnostic accuracy of endoscopic ultrasound in predicting endoscopic remission

  Wall thickness (in mm) measured by endoscopic ultrasound in predicting endoscopic remission in rectum in ulcerative colitis

  Baseline

Secondary Outcomes (7)

• Compare diagnostic accuracy of endoscopic ultrasound in predicting histologic remission

  Baseline

• Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting histologic remission

  Baseline

• Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting histologic remission

  Baseline

• Compare diagnostic accuracy of transperineal ultrasound in predicting endoscopic remission

  Baseline

• Compare diagnostic accuracy of transperineal ultrasound in predicting histlogic remission

  Baseline

Study Arms (1)

Adult patients with Ulcerative colitis

OTHER

Adult patients (18-75 years) with Ulcerative colitis Pregnant, lactating and acute severe colitis excluded

Diagnostic Test: Endoscopic Ultrasound

Interventions

Endoscopic Ultrasound DIAGNOSTIC_TEST

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.

Adult patients with Ulcerative colitis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18-75 years) with Ulcerative colitis

You may not qualify if:

• Pregnant
• Lactating mother
• Endoscopy not required
• No consent

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, India

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: December 5, 2024
• Study Start: May 27, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)