Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT01852760
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-05-09', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between EUS indices, clinical, endoscopic, and histological scores of inflammation in UC', 'timeFrame': '1 day', 'description': 'The correlation between EUS indices, clinical, endoscopic, and histological scores of inflammation in UC'}], 'secondaryOutcomes': [{'measure': 'Interobserver variability of endoscopic and histologic scores', 'timeFrame': '1 day', 'description': 'The agreement by raters of endoscopic and histologic scores of inflammation in UC using the intra-rater and inter-rater reliability.'}, {'measure': 'Interobserver variability of EUS Indices', 'timeFrame': '1 day', 'description': "The agreement by rater's of EUS indices of inflammation using the intra-rater and inter-rater reliability."}, {'measure': 'Hyperemia score correlation with UC disease activity', 'timeFrame': '1 day', 'description': 'Hyperemia on Doppler EUS to assess inflammatory changes in UC patients with active inflammation compared to quiescent disease'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endoscopic ultrasound', 'ulcerative colitis', 'inflammatory bowel disease'], 'conditions': ['Ulcerative Colitis', 'Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '19997096', 'type': 'BACKGROUND', 'citation': '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': '9831835', 'type': 'BACKGROUND', 'citation': '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': '11870572', 'type': 'BACKGROUND', 'citation': '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': '17258984', 'type': 'BACKGROUND', 'citation': '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': '16292085', 'type': 'BACKGROUND', 'citation': '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': '17258735', 'type': 'BACKGROUND', 'citation': "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': '21997563', 'type': 'BACKGROUND', 'citation': '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': '10940279', 'type': 'BACKGROUND', 'citation': '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': '15233681', 'type': 'BACKGROUND', 'citation': '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': '16530532', 'type': 'BACKGROUND', 'citation': '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': '17916108', 'type': 'BACKGROUND', 'citation': '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': '28760533', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of unknown etiology characterized by diffuse mucosal inflammation limited to the colon. The basis of medical treatment is with agents that reduce the inflammatory process. Tailoring appropriate therapy will depend on disease severity, which can be difficult to identify. A response to therapy may also require months to determine. Medications for induction of remission and/or for maintenance in patients with mild to severe UC include 5-aminosalicylates (5\'ASA), corticosteroids, azathioprine (AZA), cyclosporine, and infliximab (IFX). All medications have their own inherent side effect profile. Cost can be a major issue with some medications such as IFX, which can be tens of thousands of dollars annually. Medical management can still fail in those with severe disease necessitating surgical management with a colectomy. Identification of high-risk patients who are candidates for more intensive therapy early in the disease course might be a strategy to improve treatment outcomes and limit cost.\n\nThis notion of "individualizing" therapy is attractive and a distinct departure from the current "step-care" paradigm in which treatments are added sequentially on the basis of symptom-defined treatment failure. However, for this paradigm to be implementable an objective means of accurately stratifying risk must be identified and validated. Accordingly, increased interest has evolved in the use of biomarkers as prognostic tools. Although fecal calprotectin and serum CRP are potential candidates for this role, these tests have limitations.\n\nTransabdominal ultrasound (US) has been used in the diagnostic workup of IBD. US was a good surrogate of disease activity when compared to colonoscopy, but is unable to reliably assess the rectal wall which tends to cause the most symptoms in UC. Endoscopic ultrasound (EUS) is a highly accurate diagnostic modality for the assessment of rectal pathology. However, the role of EUS in IBD is not well defined. Tsuga et al showed total wall thickness to be highly predictive for acute inflammation in patients with UC compared to healthy controls and that the degree of rectal wall involvement correlated with endoscopic severity. Higaki et al showed patients with quiescent UC who relapsed had initial sonographic evidence of "deep" disease activity shown by significantly greater baseline thickness of the first 3 layers of the rectal wall. Yoshizawa et al subsequently demonstrated that inflammation reaching the muscularis propria or deeper predicted the need for colectomy. Hurlstone et al correlated EUS scores with histopathology, endoscopic, and clinical scores and found good concordance to only exist with superficial EUS scores. In all of these studies the investigators who performed the EUS analysis did so with knowledge of the endoscopy scores. This questions the validity of these results due to the potential for bias. Another parameter that shows promise for evaluation of inflammatory burden is EUS evaluation of blood flow. Surprisingly, Doppler flow has not been used to assess bowel wall vascularity in UC with EUS. We believe that assessment of vascularity has the potential to differentiate with a high degree of accuracy active from quiescent disease.\n\nAlthough the existing literature indicates that EUS has potential as an evaluative and prognostic tool the investigators believe that a great deal of additional research is needed to further develop this technology. This study will correlate Doppler EUS and other EUS indices with validated clinical, endoscopic, and histological indices of UC inflammation to assess its utility as a diagnostic tool. It will assess the reproducibility of these indices by calculating inter and intra-observer agreement by blinded expert reviewers. This information may have prognostic importance and might ultimately be used to guide therapy in individual patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of ulcerative colitis aged 18-85\n* Patients termed either "active" or "inactive" UC\n* Patients may be treatment naïve (ie: new diagnosis) or on existing therapy including 5\'ASA (oral or topical), AZA, corticosteroids, or IFX\n\nExclusion Criteria:\n\n* Inability to or unwillingness to undergo flexible sigmoidoscopy or colonoscopy\n* Inability to provide informed consent\n* Crohn\'s disease 4. Presence of an ileoanal pouch'}, 'identificationModule': {'nctId': 'NCT01852760', 'briefTitle': 'Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound', 'orgStudyIdInfo': {'id': 'UWO103563'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'UC in Remission', 'description': 'Patients with UC in remission'}, {'label': 'UC Mild Disease', 'description': 'Patients with mild UC disease activity based on partial Mayo Score'}, {'label': 'UC Moderate to severe', 'description': 'Patients with ulcerative colitis with moderate to severe disease activity based on partial Mayo score'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Health Care", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Brian Yan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}, {'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'Dalhousie University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Brian Yan', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}