Endoscopic Ultrasound Determines Disease Activity in Crohn's Disease And Ulcerative Colitis

NCT ID: NCT03863886

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2022-06-30

Brief 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. 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.

Conditions

Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Crohn's Disease

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.

Group Type: EXPERIMENTAL

Endoscopic ultrasound catheter (UM-2R/3R, Olympus)

Intervention Type: PROCEDURE

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.

Ulcerative Colitis

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.

Group Type: EXPERIMENTAL

Endoscopic ultrasound catheter (UM-2R/3R, Olympus)

Intervention Type: PROCEDURE

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.

Non-IBD Controls

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.

Group Type: EXPERIMENTAL

Endoscopic ultrasound catheter (UM-2R/3R, Olympus)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Pregnant patients.
• Patients with known current colorectal cancer, infectious colitis, diverticulitis, or microscopic colitis.
• Patients who have undergone surgery involving the cecum or rectum.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carilion Clinic

OTHER

Sponsor Role: lead

Responsible Party

Vu Nguyen

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vu Q Nguyen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine

Locations

Carilion Clinic

Roanoke, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vu Q Nguyen, M.D.

Role: CONTACT

vqnguyen@carilionclinic.org

5402069226

Facility Contacts

Vu Q Nguyen, M.D.

Role: primary

vqnguyen@carilionclinic.org

540-206-9226

Dario Sorrentino, M.D.

Role: backup

drsorrentino@carilionclinic.org

5402245170

References

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Reference Type: RESULT

PMID: 27660341 (View on PubMed)

Magro 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.

Reference Type: RESULT

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Reference Type: RESULT

PMID: 26855535 (View on PubMed)

Ellrichmann 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.

Reference Type: RESULT

PMID: 24612000 (View on PubMed)

Nguyen 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.

Reference Type: DERIVED

PMID: 36343674 (View on PubMed)

Other Identifiers

2694

Identifier Type: -

Identifier Source: org_study_id