Ulcerative ColitisTRINITYNCT06717906
Comparing TRIple Rectal Ultrasound Imaging Technology in Ulcerative Colitis
A study testing Endoscopic Ultrasound in people with Ulcerative Colitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Endoscopic Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteIndia
- Study dates
- 27 May 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-75 years) with Ulcerative colitis
Who cannot join
- Pregnant
- Lactating mother
- Endoscopy not required
- No consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Three Modalities (Trans Abdominal, Trans-perineal and Endoscopic Ultrasound) of Ultrasonography for Rectal Imaging in Ulcerative Colitis: The TRINITY Study
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).
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Endoscopic Ultrasound
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic UltrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with Ulcerative colitis | Other | Adult patients (18-75 years) with Ulcerative colitis Pregnant, lactating and acute severe colitis excluded Receives: Diagnostic Test: Endoscopic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (7)
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
Measured: Baseline
Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting histologic remission
Vascularity grades (modified Limberg scale: score 0-3, higher score indicates worse outcome) measured by endoscopic ultrasound in predicting histologic remission in ulcerative colitis
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start27 May 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717906
- Sponsor's protocol ID
- AGPL/TRINITY/01; Version:01
- Acronym
- TRINITY
- Status last verified
- Dec 2024
- First submitted
- 18 Aug 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Three Modalities (Trans Abdominal, Trans-perineal and Endoscopic Ultrasound) of Ultrasonography for Rectal Imaging in Ulcerative Colitis: The TRINITY Study
- ClinicalTrials.gov ID
- NCT06717906
- Acronym / sponsor ID
- TRINITY / AGPL/TRINITY/01; Version:01
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with Ulcerative colitis | Other | Diagnostic Test: Endoscopic UltrasoundAdult patients (18-75 years) with Ulcerative colitis Pregnant, lactating and acute severe colitis excluded |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18-75 years) with Ulcerative colitis
Key exclusion criteria (4 listed)
- Pregnant
- Lactating mother
- Endoscopy not required
- No consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic UltrasoundIf 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. | Diagnostic test | Adult patients with Ulcerative colitis |
Primary outcome
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
7 secondary outcomes
Compare diagnostic accuracy of endoscopic ultrasound in predicting histologic remission
Time frame: Baseline
Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting histologic remission
Time frame: Baseline
Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting histologic remission
Time frame: Baseline
Compare diagnostic accuracy of transperineal ultrasound in predicting endoscopic remission
Time frame: Baseline
Compare diagnostic accuracy of transperineal ultrasound in predicting histlogic remission
Time frame: Baseline
Compare diagnostic accuracy of endoscopic ultrasound vascularity in predicting endoscopic remission
Time frame: Baseline
Compare diagnostic accuracy of transperineal ultrasound vascularity in predicting endoscopic remission
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound in people with Ulcerative Colitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare diagnostic accuracy of endoscopic ultrasound in predicting endoscopic remission (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.