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

NCT03863886 | Unknown FDA Device

• 1 other identifier: 2694
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  Day 1

Study Arms (3)

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.

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.

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.

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

Interventions

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

Crohn's Disease; Non-IBD Controls; Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24016, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 27660341 RESULT

• 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.

  PMID: 28158501 RESULT

• Tontini 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.

  PMID: 25574078 RESULT

• Cartana 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.

  PMID: 26855535 RESULT

• 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.

  PMID: 24612000 RESULT

• 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.

  PMID: 36343674 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Vu Q Nguyen, M.D.

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vu Q Nguyen, M.D.

CONTACT

5402069226; vqnguyen@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: March 5, 2019
• Study Start: January 4, 2019
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)