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Clinical Trials/NCT06717906
NCT06717906CompletedNot Applicable

Comparing Three Modalities (Trans Abdominal, Trans-perineal and Endoscopic Ultrasound) of Ultrasonography for Rectal Imaging in Ulcerative Colitis: The TRINITY Study

Asian Institute of Gastroenterology, India2 sites in 1 country142 target enrollmentStarted: May 27, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
142
Locations
2
Primary Endpoint
Compare diagnostic accuracy of endoscopic ultrasound in predicting endoscopic remission

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Lactating mother
  • Endoscopy not required
  • No consent

Outcomes

Primary Outcomes

Compare diagnostic accuracy of endoscopic ultrasound in predicting endoscopic remission

Time Frame: Baseline

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

Secondary Outcomes

  • 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)
  • Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting endoscopic remission(Baseline)
  • Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting endoscopic remission(Baseline)

Investigators

Sponsor
Asian Institute of Gastroenterology, India
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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