Crohn DiseaseEUSIBDNCT03863886
Endoscopic Ultrasound Determines Disease Activity in Crohn's Disease And Ulcerative Colitis
A study testing Endoscopic ultrasound catheter (UM-2R/3R, Olympus) in people with Crohn Disease and Ulcerative Colitis, run by Carilion Clinic at 1 site in United States.
Trial summary
Although Crohn's disease and ulcerative colitis are the main subtypes of inflammatory bowel disease, they differ substantially in disease behavior, prognosis, and treatment paradigm. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- What is being tested?
- Endoscopic ultrasound catheter (UM-2R/3R, Olympus)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2019to Jun 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults patients ≥ 18 years of age with CD with at least colonic involvement, UC, or non-IBD controls who have been referred for colonoscopy for clinical reasons. The clinical reasons may include colorectal cancer screening, surveillance, diagnostic for CD or UC flare, or gastrointestinal symptoms.
Who cannot join
- Pregnant patients.
- Patients with known current colorectal cancer, infectious colitis, diverticulitis, or microscopic colitis.
- Patients who have undergone surgery involving the cecum or rectum.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24016
Vu Q Nguyen, M.D., 540-206-9226, vqnguyen@carilionclinic.org
Dario Sorrentino, M.D., 5402245170, drsorrentino@carilionclinic.org
About this study
Although Crohn's disease and ulcerative colitis are the main subtypes of inflammatory bowel disease, they differ substantially in disease behavior, prognosis, and treatment paradigm. However, making an accurate diagnosis of Crohn's disease versus ulcerative colitis and assessing disease activity beyond the level of mucosal inflammation remain challenging with contemporary modalities. The objective of the study is to determine the novel role of endoscopic ultrasound in A) differentiating Crohn's colitis versus ulcerative colitis and B) monitoring disease activity in these patients.
Read the detailed description
Crohn's disease (CD) and ulcerative colitis (UC) are two principal subtypes of inflammatory bowel disease (IBD). Disease behavior, prognosis, and therapy differ substantially between these two subtypes. However, up to 15% of patients may have misclassification of their IBD subtypes leading to significant delay in appropriate management and prognostication. The misclassification of CD and UC is due to limitations in contemporary modalities used to diagnose these diseases. While CD involves transmural inflammation and UC is limited to mucosal inflammation, the combination of endoscopy, histology, and cross-sectional imaging typically used to establish the diagnosis do not reliably distinguish mucosal from submucosal inflammation. Consequently, disease reclassification often occurs at the time of surgery when transmural inflammation can be determined from the surgical specimen. At that time, medical therapy has already failed. The optimal time for accurate IBD classification would be at the initial diagnosis, allowing for appropriate targeted therapy to achieve optimal disease outcomes.
Endoscopic ultrasound (EUS) can provide detailed information about luminal wall layers. To date, the use of endoscopic ultrasound (EUS) for colorectal disease has been limited to staging of subepithelial lesions and examining CD-related perianal complications. The ultrasound miniprobe device (UM-2/3R, Olympus) is a thin ultrasound catheter that can be passed through the colonoscope's accessory channel to perform detailed ultrasonic assessment of any colon wall segments. Prior studies have demonstrated that the submucosal layer is significant thicker in active CD compared to active UC, while active UC has thicker mucosal layer comparatively. This study tests the hypothesis that the addition of the miniprobe ultrasound catheter at the time of colonoscopy will help to differentiate active CD with colonic involvement and UC from non-IBD controls by comparing the differential thickness in the mucosal and submucosal layer among these groups of patients. Furthermore, the investigators hypothesize that the thickness of differential wall layers in CD and UC patients will correlate to clinical and endoscopic disease activity. The significance of these findings will help establish an accurate diagnosis of IBD subtypes early in the disease course and provide for a reliable method to monitor disease activity not only at the mucosal layer but also in deeper luminal wall layers.
- Conditions
- Crohn Disease, Ulcerative Colitis
- Being tested
- Endoscopic ultrasound catheter (UM-2R/3R, Olympus)
- Keywords
- crohn's disease, ulcerative colitis, endoscopic ultrasound, inflammatory bowel disease
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound catheter (UM-2R/3R, Olympus)Procedure or surgery
A miniprobe ultrasound catheter (UM-2R/3R, Olympus) will be passed into the colonoscope's accessory channel at the time of colonoscopy to measure the thickness of the different colon wall layers (mucosa, submucosa, muscular propria, and total wall thickness) in the cecum and rectum.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease | Experimental | 20 patients with Crohn's disease with at least colonic involvement will undergo endoscopic ultrasound assessment of the thickness of wall layers (mucosa, submucosa, muscularis propria, total wall) at the rectum and cecum region during their standard-of-care colonoscopy. Receives: Procedure: Endoscopic ultrasound catheter (UM-2R/3R, Olympus) |
| Ulcerative Colitis | Experimental | 20 patients with ulcerative colitis will undergo endoscopic ultrasound assessment of the thickness of wall layers (mucosa, submucosa, muscularis propria, total wall) at the rectum and cecum region during their standard-of-care colonoscopy. Receives: Procedure: Endoscopic ultrasound catheter (UM-2R/3R, Olympus) |
| Non-IBD Controls | Experimental | 20 patients without inflammatory bowel disease (controls) will undergo endoscopic ultrasound assessment of the thickness of wall layers (mucosa, submucosa, muscularis propria, total wall) at the rectum and cecum region during their standard-of-care colonoscopy. Receives: Procedure: Endoscopic ultrasound catheter (UM-2R/3R, Olympus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Crohn's disease has significantly thicker submucosa layer compared to patients with active ulcerative colitis and non-inflammatory bowel disease controls.
We are measuring the different colon wall layer thickness including the mucosa, submucosa, muscularis propria, and total wall layer (in mm) using the endoscopic ultrasound device and comparing the different levels of colon wall layer thickness between patients with active versus inactive ulcerative colitis, active versus inactive Crohn's disease, and comparing those to controls.
Measured: Day 1
Secondary outcomes (2)
The thickness of the submucosa layer in Crohn's disease patients correlates to the degree of disease activity as measured by the Harvey-Bradshaw clinical index and Simple Endoscopic Score index.
We will correlate the thickness (in mm) of the submucosa layer in Crohn's disease patients measured by endoscopic ultrasound to the degree of disease activity at the time of procedure as measured by the Harvey-Brashaw index and Simple Endoscopic Score (SES-CD) index.
Measured: Day 1
The thickness of the mucosa layer in ulcerative colitis patients correlates to the degree of disease activity as measured by the Mayo score index.
We will correlate the thickness (in mm) of the mucosa layer in ulcerative colitis patients measured by endoscopic ultrasound to the degree of disease activity at the time of procedure as measured by the Mayo score index.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start4 Jan 2019
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vu Nguyen, Carilion Clinic
- Investigators
- Vu Q Nguyen, M.D., Principal investigator, Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863886
- Sponsor's protocol ID
- 2694
- Acronym
- EUSIBD
- Status last verified
- Apr 2021
- First submitted
- 22 Jan 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gomollon F, Dignass A, Annese V, Tilg H, Van Assche G, Lindsay JO, Peyrin-Biroulet L, Cullen GJ, Daperno M, Kucharzik T, Rieder F, Almer S, Armuzzi A, Harbord M, Langhorst J, Sans M, Chowers Y, Fiorino G, Juillerat P, Mantzaris GJ, Rizzello F, Vavricka S, Gionchetti P; ECCO. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 1: Diagnosis and Medical Management. J Crohns Colitis. 2017 Jan;11(1):3-25. doi: 10.1093/ecco-jcc/jjw168. Epub 2016 Sep 22.
PubMed 27660341Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, Burisch J, Gecse KB, Hart AL, Hindryckx P, Langner C, Limdi JK, Pellino G, Zagorowicz E, Raine T, Harbord M, Rieder F; European Crohn's and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: Definitions, Diagnosis, Extra-intestinal Manifestations, Pregnancy, Cancer Surveillance, Surgery, and Ileo-anal Pouch Disorders. J Crohns Colitis. 2017 Jun 1;11(6):649-670. doi: 10.1093/ecco-jcc/jjx008. No abstract available.
PubMed 28158501Tontini GE, Vecchi M, Pastorelli L, Neurath MF, Neumann H. Differential diagnosis in inflammatory bowel disease colitis: state of the art and future perspectives. World J Gastroenterol. 2015 Jan 7;21(1):21-46. doi: 10.3748/wjg.v21.i1.21.
PubMed 25574078Cartana ET, Gheonea DI, Saftoiu A. Advances in endoscopic ultrasound imaging of colorectal diseases. World J Gastroenterol. 2016 Feb 7;22(5):1756-66. doi: 10.3748/wjg.v22.i5.1756.
PubMed 26855535Ellrichmann M, Wietzke-Braun P, Dhar S, Nikolaus S, Arlt A, Bethge J, Kuehbacher T, Wintermeyer L, Balschun K, Klapper W, Schreiber S, Fritscher-Ravens A. Endoscopic ultrasound of the colon for the differentiation of Crohn's disease and ulcerative colitis in comparison with healthy controls. Aliment Pharmacol Ther. 2014 Apr;39(8):823-33. doi: 10.1111/apt.12671. Epub 2014 Feb 25.
PubMed 24612000Nguyen VQ, Celio F, Chitnavis M, Shakhatreh M, Katz J, Cominelli F, Chak A, Yeaton P. Role of through-the-scope catheter-based EUS in inflammatory bowel disease diagnosis and activity assessment. Gastrointest Endosc. 2023 Apr;97(4):752-758.e2. doi: 10.1016/j.gie.2022.10.043. Epub 2022 Nov 4.
PubMed 36343674
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Determines Disease Activity in Crohn's Disease And Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03863886
- Acronym / sponsor ID
- EUSIBD / 2694
- Conditions
- Crohn Disease, Ulcerative Colitis
- Keywords
- crohn's disease, ulcerative colitis, endoscopic ultrasound, inflammatory bowel disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 5 Mar 2019 (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.
Although Crohn's disease and ulcerative colitis are the main subtypes of inflammatory bowel disease, they differ substantially in disease behavior, prognosis, and treatment paradigm. However, making an accurate diagnosis of Crohn's disease versus ulcerative colitis and assessing disease activity beyond the level of mucosal inflammation remain challenging with contemporary modalities. The objective of the study is to determine the novel role of endoscopic ultrasound in A) differentiating Crohn's colitis versus ulcerative colitis and B) monitoring disease activity in these patients.
Detailed description
Crohn's disease (CD) and ulcerative colitis (UC) are two principal subtypes of inflammatory bowel disease (IBD). Disease behavior, prognosis, and therapy differ substantially between these two subtypes. However, up to 15% of patients may have misclassification of their IBD subtypes leading to significant delay in appropriate management and prognostication. The misclassification of CD and UC is due to limitations in contemporary modalities used to diagnose these diseases. While CD involves transmural inflammation and UC is limited to mucosal inflammation, the combination of endoscopy, histology, and cross-sectional imaging typically used to establish the diagnosis do not reliably distinguish mucosal from submucosal inflammation. Consequently, disease reclassification often occurs at the time of surgery when transmural inflammation can be determined from the surgical specimen. At that time, medical therapy has already failed. The optimal time for accurate IBD classification would be at the initial diagnosis, allowing for appropriate targeted therapy to achieve optimal disease outcomes.
Endoscopic ultrasound (EUS) can provide detailed information about luminal wall layers. To date, the use of endoscopic ultrasound (EUS) for colorectal disease has been limited to staging of subepithelial lesions and examining CD-related perianal complications. The ultrasound miniprobe device (UM-2/3R, Olympus) is a thin ultrasound catheter that can be passed through the colonoscope's accessory channel to perform detailed ultrasonic assessment of any colon wall segments. Prior studies have demonstrated that the submucosal layer is significant thicker in active CD compared to active UC, while active UC has thicker mucosal layer comparatively. This study tests the hypothesis that the addition of the miniprobe ultrasound catheter at the time of colonoscopy will help to differentiate active CD with colonic involvement and UC from non-IBD controls by comparing the differential thickness in the mucosal and submucosal layer among these groups of patients. Furthermore, the investigators hypothesize that the thickness of differential wall layers in CD and UC patients will correlate to clinical and endoscopic disease activity. The significance of these findings will help establish an accurate diagnosis of IBD subtypes early in the disease course and provide for a reliable method to monitor disease activity not only at the mucosal layer but also in deeper luminal wall layers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease | Experimental | Procedure: Endoscopic ultrasound catheter (UM-2R/3R, Olympus)20 patients with Crohn's disease with at least colonic involvement will undergo endoscopic ultrasound assessment of the thickness of wall layers (mucosa, submucosa, muscularis propria, total wall) at the rectum and cecum region during their standard-of-care colonoscopy. |
| Ulcerative Colitis | Experimental | Procedure: Endoscopic ultrasound catheter (UM-2R/3R, Olympus)20 patients with ulcerative colitis will undergo endoscopic ultrasound assessment of the thickness of wall layers (mucosa, submucosa, muscularis propria, total wall) at the rectum and cecum region during their standard-of-care colonoscopy. |
| Non-IBD Controls | Experimental | Procedure: Endoscopic ultrasound catheter (UM-2R/3R, Olympus)20 patients without inflammatory bowel disease (controls) will undergo endoscopic ultrasound assessment of the thickness of wall layers (mucosa, submucosa, muscularis propria, total wall) at the rectum and cecum region during their standard-of-care colonoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients ≥ 18 years of age with CD with at least colonic involvement, UC, or non-IBD controls who have been referred for colonoscopy for clinical reasons. The clinical reasons may include colorectal cancer screening, surveillance, diagnostic for CD or UC flare, or gastrointestinal symptoms.
Key exclusion criteria (3 listed)
- Pregnant patients.
- Patients with known current colorectal cancer, infectious colitis, diverticulitis, or microscopic colitis.
- Patients who have undergone surgery involving the cecum or rectum.
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 ultrasound catheter (UM-2R/3R, Olympus)A miniprobe ultrasound catheter (UM-2R/3R, Olympus) will be passed into the colonoscope's accessory channel at the time of colonoscopy to measure the thickness of the different colon wall layers (mucosa, submucosa, muscular propria, and total wall thickness) in the cecum and rectum. | Procedure or surgery | Crohn's Disease, Non-IBD Controls, Ulcerative Colitis |
Primary outcome
Active Crohn's disease has significantly thicker submucosa layer compared to patients with active ulcerative colitis and non-inflammatory bowel disease controls.
Time frame: Day 1
We are measuring the different colon wall layer thickness including the mucosa, submucosa, muscularis propria, and total wall layer (in mm) using the endoscopic ultrasound device and comparing the different levels of colon wall layer thickness between patients with active versus inactive ulcerative colitis, active versus inactive Crohn's disease, and comparing those to controls.
2 secondary outcomes
The thickness of the submucosa layer in Crohn's disease patients correlates to the degree of disease activity as measured by the Harvey-Bradshaw clinical index and Simple Endoscopic Score index.
Time frame: Day 1
The thickness of the mucosa layer in ulcerative colitis patients correlates to the degree of disease activity as measured by the Mayo score index.
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Results publication: PubMed 27660341Gomollon F, Dignass A, Annese V, Tilg H, Van Assche G, Lindsay JO, Peyrin-Biroulet L, Cullen GJ, Daperno M, Kucharzik T, Rieder F, Almer S, Armuzzi A, Harbord M, Langhorst J, Sans M, Chowers Y, Fiorino G, Juillerat P, Mantzaris GJ, Rizzello F, Vavricka S, Gionchetti P; ECCO. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 1: Diagnosis and Medical Management. J Crohns Colitis. 2017 Jan;11(1):3-25. doi: 10.1093/ecco-jcc/jjw168. Epub 2016 Sep 22.
- Results publication: PubMed 28158501Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, Burisch J, Gecse KB, Hart AL, Hindryckx P, Langner C, Limdi JK, Pellino G, Zagorowicz E, Raine T, Harbord M, Rieder F; European Crohn's and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: Definitions, Diagnosis, Extra-intestinal Manifestations, Pregnancy, Cancer Surveillance, Surgery, and Ileo-anal Pouch Disorders. J Crohns Colitis. 2017 Jun 1;11(6):649-670. doi: 10.1093/ecco-jcc/jjx008. No abstract available.
- Results publication: PubMed 25574078Tontini GE, Vecchi M, Pastorelli L, Neurath MF, Neumann H. Differential diagnosis in inflammatory bowel disease colitis: state of the art and future perspectives. World J Gastroenterol. 2015 Jan 7;21(1):21-46. doi: 10.3748/wjg.v21.i1.21.
- Results publication: PubMed 26855535Cartana ET, Gheonea DI, Saftoiu A. Advances in endoscopic ultrasound imaging of colorectal diseases. World J Gastroenterol. 2016 Feb 7;22(5):1756-66. doi: 10.3748/wjg.v22.i5.1756.
- Results publication: PubMed 24612000Ellrichmann M, Wietzke-Braun P, Dhar S, Nikolaus S, Arlt A, Bethge J, Kuehbacher T, Wintermeyer L, Balschun K, Klapper W, Schreiber S, Fritscher-Ravens A. Endoscopic ultrasound of the colon for the differentiation of Crohn's disease and ulcerative colitis in comparison with healthy controls. Aliment Pharmacol Ther. 2014 Apr;39(8):823-33. doi: 10.1111/apt.12671. Epub 2014 Feb 25.
- Derived from this study: PubMed 36343674Nguyen VQ, Celio F, Chitnavis M, Shakhatreh M, Katz J, Cominelli F, Chak A, Yeaton P. Role of through-the-scope catheter-based EUS in inflammatory bowel disease diagnosis and activity assessment. Gastrointest Endosc. 2023 Apr;97(4):752-758.e2. doi: 10.1016/j.gie.2022.10.043. Epub 2022 Nov 4.
- 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.
Vu Q Nguyen, M.D. principal investigator
Assistant Professor of Medicine
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 catheter (UM-2R/3R, Olympus) in people with Crohn Disease and Ulcerative Colitis, run by Carilion Clinic at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Apr 2021. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vu Q Nguyen, M.D. (5402069226, vqnguyen@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Crohn's disease has significantly thicker submucosa layer compared to patients with active ulcerative colitis and non-inflammatory bowel disease controls. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863886, which also lists 6 linked publications.
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 29 Apr 2021.