Comparing TRIple Rectal Ultrasound Imaging Technology in Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis

• Registration Number: NCT06717906
• Lead Sponsor: Asian Institute of Gastroenterology, India

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).

Detailed Description

This study is designed to assess the correlation of rectal wall thickness and vascularity measurements obtained through trans-abdominal ultrasound (TAS), trans-perineal ultrasound (TPUS), and endoscopic ultrasound (EUS) in adult patients with ulcerative colitis (UC). The primary goal is to determine how well rectal total wall thickness measured via TPUS correlates with EUS findings. Secondary objectives include comparing rectal wall thickness and vascularity measured by TAS, TPUS, and EUS with endoscopic activity, histologic activity, and fecal calprotectin (FCP) levels. Additionally, the study aims to evaluate changes in patient management resulting from additional investigations, such as sigmoidoscopy and EUS, over the standard TAS and TPUS procedures. UC patients attending an inflammatory bowel disease (IBD) clinic will undergo a clinical assessment using the Simple Clinical Colitis Activity Index (SCCAI), followed by baseline TAS and TPUS, both performed as point-of-care tests. If deemed clinically necessary, patients will also undergo sigmoidoscopy and EUS during the same visit, with rectal wall thickness and vascularity measured across different rectal sections and correlated with histologic inflammation assessed via biopsy and measured by the Nancy histologic index. The study will also explore correlations with FCP levels where data are available. This cross-sectional study includes a follow-up period until biopsy results are obtained, with an estimated recruitment duration of 6-12 months and a target sample size of 50 patients.

Study Timeline

• Study Start: 2024-05-27
• Study First Submitted: 2024-08-18
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04-26
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Compare diagnostic accuracy of endoscopic ultrasound in predicting endoscopic remission	Baseline	Wall thickness (in mm) measured by endoscopic ultrasound in predicting endoscopic remission in rectum in ulcerative colitis

Secondary Outcome Measures

Name	Time	Method
Compare diagnostic accuracy of endoscopic ultrasound in predicting histologic remission	Baseline	Wall thickness (in mm) measured by endoscopic ultrasound in predicting histologic remission in rectum in ulcerative colitis
Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting histologic remission	Baseline	Vascularity grades (modified Limberg scale: score 0-3, higher score indicates worse outcome) measured by endoscopic ultrasound in predicting histologic remission in ulcerative colitis
Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting histologic remission	Baseline	Vascularity grades (modified Limberg score: 0-3, higher score indicates worse outcome) measured by transperineal ultrasound in predicting histologic remission in ulcerative colitis
Compare diagnostic accuracy of transperineal ultrasound in predicting endoscopic remission	Baseline	Wall thickness (in mm) measured by transperineal ultrasound in predicting endoscopic remission in rectum in ulcerative colitis
Compare diagnostic accuracy of transperineal ultrasound in predicting histlogic remission	Baseline	Wall thickness (in mm) measured by endoscopic ultrasound in predicting histologic remission in rectum in ulcerative colitis
Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting endoscopic remission	Baseline	Vascularity grades (modified Limberg score: 0-3, higher score indicates worse outcome) measured by endoscopic ultrasound in predicting endoscopic remission in rectum in ulcerative colitis
Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting endoscopic remission	Baseline	Vascularity grades (modified Limberg score: 0-3, higher score indicates worse outcome) measured by transperineal ultrasound in predicting endoscopioc remission in ulcerative colitis

Trial Locations

Locations (1)

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, India