Recruiting

Endoscopic Ultrasound

Sponsor:

Carilion Clinic

Code:

NCT03863886

Conditions

Crohn Disease

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

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

Study Details

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.

Conditions

Crohn Disease

Ulcerative Colitis

Study ID

NCT03863886

Start date

Jan 4, 2019

Status verified date

Apr, 2021

Completion date

Jun, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

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.

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 ]

Central Contacts and Locations

Central contacts

Vu Q Nguyen, M.D.

5402069226vqnguyen@carilionclinic.org

Locations

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Vu Q Nguyen, M.D.

540-206-9226vqnguyen@carilionclinic.org

Dario Sorrentino, M.D.

5402245170drsorrentino@carilionclinic.org

More Information

Sponsor

Carilion Clinic

Last update posted

Apr 29, 2021

Last verified

Apr, 2021

Keywords

  • crohn's disease
  • ulcerative colitis
  • endoscopic ultrasound
  • inflammatory bowel disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2021-04-29.