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Completed

NCT Number: NCT06717906

Comparing TRIple Rectal Ultrasound Imaging Technology in Ulcerative Colitis

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).

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Institute of Gastroenterology

Hyderabad, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Compare diagnostic accuracy of endoscopic ultrasound in predicting histologic remission

    Time frame: Baseline

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

  2. Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting histologic remission

    Time frame: 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

  3. Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting histologic remission

    Time frame: Baseline

    Vascularity grades (modified Limberg score: 0-3, higher score indicates worse outcome) measured by transperineal ultrasound in predicting histologic remission in ulcerative colitis

  4. Compare diagnostic accuracy of transperineal ultrasound in predicting endoscopic remission

    Time frame: Baseline

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

  5. Compare diagnostic accuracy of transperineal ultrasound in predicting histlogic remission

    Time frame: Baseline

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

  6. Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting endoscopic remission

    Time frame: 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

  7. Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting endoscopic remission

    Time frame: Baseline

    Vascularity grades (modified Limberg score: 0-3, higher score indicates worse outcome) measured by transperineal ultrasound in predicting endoscopioc remission in ulcerative colitis

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Acronym: TRINITY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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