Clinical trial NCT06717906: Comparing TRIple Rectal Ultrasound Imaging Technology in Ulcerative Colitis
Official title: Comparing Three Modalities (Trans Abdominal, Trans-perineal and Endoscopic Ultrasound) of Ultrasonography for Rectal Imaging in Ulcerative Colitis: the TRINITY Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Compare diagnostic accuracy of endoscopic ultrasound in predicting endoscopic remission
timeFrame: Baseline
Secondary outcomes:
measure: Compare diagnostic accuracy of endoscopic ultrasound in predicting histologic remission
timeFrame: Baseline
measure: Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting histologic remission
timeFrame: Baseline
measure: Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting histologic remission
timeFrame: Baseline
measure: Compare diagnostic accuracy of transperineal ultrasound in predicting endoscopic remission
timeFrame: Baseline
measure: Compare diagnostic accuracy of transperineal ultrasound in predicting histlogic remission
timeFrame: Baseline
measure: Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting endoscopic remission
timeFrame: Baseline
measure: Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting endoscopic remission
timeFrame: Baseline
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
Study officials:
References: