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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with Ulcerative colitis | Other | Adult patients (18-75 years) with Ulcerative colitis Pregnant, lactating and acute severe colitis excluded |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare diagnostic accuracy of endoscopic ultrasound in predicting histologic remission | Wall thickness (in mm) measured by endoscopic ultrasound in predicting histologic remission in rectum in ulcerative colitis | Baseline |
| Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting histologic remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology | Hyderabad | India |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
Vascularity grades (modified Limberg scale: score 0-3, higher score indicates worse outcome) measured by endoscopic ultrasound in predicting histologic remission in ulcerative colitis |
| Baseline |
| Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting histologic remission | Vascularity grades (modified Limberg score: 0-3, higher score indicates worse outcome) measured by transperineal ultrasound in predicting histologic remission in ulcerative colitis | Baseline |
| Compare diagnostic accuracy of transperineal ultrasound in predicting endoscopic remission | Wall thickness (in mm) measured by transperineal ultrasound in predicting endoscopic remission in rectum in ulcerative colitis | Baseline |
| Compare diagnostic accuracy of transperineal ultrasound in predicting histlogic remission | Wall thickness (in mm) measured by endoscopic ultrasound in predicting histologic remission in rectum in ulcerative colitis | Baseline |
| Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting endoscopic remission | 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 | Baseline |
| Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting endoscopic remission | Vascularity grades (modified Limberg score: 0-3, higher score indicates worse outcome) measured by transperineal ultrasound in predicting endoscopioc remission in ulcerative colitis | Baseline |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |