Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound

NCT01852760 | Completed

• 1 other identifier: UWO103563
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this cross-sectional study patients with active or quiescent ulcerative colitis will be studied to determine the utility of endoscopic ultrasound measurements of rectal wall blood flow and thickness as reliable indices of disease severity and the degree of correlation that exists with validated clinical, endoscopic, and histological indices.

Conditions

Ulcerative Colitis; Inflammatory Bowel Disease

Keywords

endoscopic ultrasound; ulcerative colitis; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• The correlation between EUS indices, clinical, endoscopic, and histological scores of inflammation in UC

  The correlation between EUS indices, clinical, endoscopic, and histological scores of inflammation in UC

  1 day

Secondary Outcomes (3)

• Interobserver variability of endoscopic and histologic scores

  1 day

• Interobserver variability of EUS Indices

  1 day

• Hyperemia score correlation with UC disease activity

  1 day

Study Arms (3)

UC in Remission

Patients with UC in remission

UC Mild Disease

Patients with mild UC disease activity based on partial Mayo Score

UC Moderate to severe

Patients with ulcerative colitis with moderate to severe disease activity based on partial Mayo score

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients with IBD attending outpatient IBD clinics at the University of Western Ontario teaching hospitals and patients admitted to hospital with severe UC will be included for endoscopic ultrasound assessment.

You may qualify if:

• Patients with a confirmed diagnosis of ulcerative colitis aged 18-85
• Patients termed either "active" or "inactive" UC
• Patients may be treatment naïve (ie: new diagnosis) or on existing therapy including 5'ASA (oral or topical), AZA, corticosteroids, or IFX

You may not qualify if:

• Inability to or unwillingness to undergo flexible sigmoidoscopy or colonoscopy
• Inability to provide informed consent
• Crohn's disease 4. Presence of an ileoanal pouch

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator
• University of Calgary: collaborator
• University of Toronto: collaborator
• Dalhousie University: collaborator

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (12)

• Parente F, Molteni M, Marino B, Colli A, Ardizzone S, Greco S, Sampietro G, Foschi D, Gallus S. Are colonoscopy and bowel ultrasound useful for assessing response to short-term therapy and predicting disease outcome of moderate-to-severe forms of ulcerative colitis?: a prospective study. Am J Gastroenterol. 2010 May;105(5):1150-7. doi: 10.1038/ajg.2009.672. Epub 2009 Dec 8.

  PMID: 19997096 BACKGROUND

• Tsuga K, Haruma K, Fujimura J, Hata J, Tani H, Tanaka S, Sumii K, Kajiyama G. Evaluation of the colorectal wall in normal subjects and patients with ulcerative colitis using an ultrasonic catheter probe. Gastrointest Endosc. 1998 Nov;48(5):477-84. doi: 10.1016/s0016-5107(98)70088-4.

  PMID: 9831835 BACKGROUND

• Higaki S, Nohara H, Saitoh Y, Akazawa A, Yanai H, Yoshida T, Okita K. Increased rectal wall thickness may predict relapse in ulcerative colitis: a pilot follow-up study by ultrasonographic colonoscopy. Endoscopy. 2002 Mar;34(3):212-9. doi: 10.1055/s-2002-20293.

  PMID: 11870572 BACKGROUND

• Yoshizawa S, Kobayashi K, Katsumata T, Saigenji K, Okayasu I. Clinical usefulness of EUS for active ulcerative colitis. Gastrointest Endosc. 2007 Feb;65(2):253-60. doi: 10.1016/j.gie.2005.10.037.

  PMID: 17258984 BACKGROUND

• Hurlstone DP, Sanders DS, Lobo AJ, McAlindon ME, Cross SS. Prospective evaluation of high-frequency mini-probe ultrasound colonoscopic imaging in ulcerative colitis: a valid tool for predicting clinical severity. Eur J Gastroenterol Hepatol. 2005 Dec;17(12):1325-31. doi: 10.1097/00042737-200512000-00010.

  PMID: 16292085 BACKGROUND

• D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.

  PMID: 17258735 BACKGROUND

• Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, Feagan BG, Hanauer SB, Lemann M, Lichtenstein GR, Marteau PR, Reinisch W, Sands BE, Yacyshyn BR, Bernhardt CA, Mary JY, Sandborn WJ. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Gut. 2012 Apr;61(4):535-42. doi: 10.1136/gutjnl-2011-300486. Epub 2011 Oct 13.

  PMID: 21997563 BACKGROUND

• Geboes K, Riddell R, Ost A, Jensfelt B, Persson T, Lofberg R. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut. 2000 Sep;47(3):404-9. doi: 10.1136/gut.47.3.404.

  PMID: 10940279 BACKGROUND

• Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2004 Jul;99(7):1371-85. doi: 10.1111/j.1572-0241.2004.40036.x.

  PMID: 15233681 BACKGROUND

• Lichtenstein GR, Abreu MT, Cohen R, Tremaine W; American Gastroenterological Association. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology. 2006 Mar;130(3):940-87. doi: 10.1053/j.gastro.2006.01.048. No abstract available.

  PMID: 16530532 BACKGROUND

• Langhorst J, Elsenbruch S, Koelzer J, Rueffer A, Michalsen A, Dobos GJ. Noninvasive markers in the assessment of intestinal inflammation in inflammatory bowel diseases: performance of fecal lactoferrin, calprotectin, and PMN-elastase, CRP, and clinical indices. Am J Gastroenterol. 2008 Jan;103(1):162-9. doi: 10.1111/j.1572-0241.2007.01556.x. Epub 2007 Oct 4.

  PMID: 17916108 BACKGROUND

• Yan B, Feagan B, Teriaky A, Mosli M, Mohamed R, Williams G, Yeung E, Yong E, Haig A, Sey M, Stitt L, Zou GY, Jairath V. Reliability of EUS indices to detect inflammation in ulcerative colitis. Gastrointest Endosc. 2017 Dec;86(6):1079-1087. doi: 10.1016/j.gie.2017.07.035. Epub 2017 Jul 29.

  PMID: 28760533 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian Yan, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 14, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

CA (1)