Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis
NCT ID: NCT00587236
Last Updated: 2016-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
65 participants
OBSERVATIONAL
2006-03-31
2010-08-31
Brief Summary
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To attempt to increase the detection of precancerous colon tissue in patients with chronic ulcerative colitis and primary sclerosing cholangitis;
To determine if an investigational scope that can look at the lining of the colon in different ways will help the doctor identify abnormal tissue in patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis; and
To determine if this investigational scope can accurately detect precancerous or cancerous tissue in patients with chronic ulcerative colitis that are known to have had cancerous or precancerous tissue in the past.
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Detailed Description
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All lesions detected will be documented and biopsied for a maximum of four biopsies per suspicious lesion. Note will be taken of which modality resulted in visualization of the lesion. Data on the factors under study will be collected: i) disease type (CUC + PSC or CUC with known dysplasia), ii) Age, iii) Sex, iv) length of time with disease, v) extent of disease, vi) the interaction between iv and v will be collected. In addition, dysplasia yes/no will be established after biopsy histology is established and the modality under which abnormalities were observed will also be recorded.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis.
No interventions assigned to this group
2
Patients with chronic ulcerative colitis and known dysplasia or cancer.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* able to give informed written consent
* history of chronic ulcerative colitis and colonic dysplasia/or cancer or primary sclerosing cholangitis
Exclusion Criteria
* INR ./= 2.5 or thrombocytopenia ,50,000
* patients with clinically important cardiopulmonary disease who are unable to safely undergo prolonged conscious sedation
* pregnancy
* symptomatic coronary artery disease
18 Years
75 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Christopher J. Gostout
PI
Principal Investigators
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Christopher J Gostout, MD
Role: STUDY_DIRECTOR
Mayo Clinic, Rochester, MN
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Eaden JA, Abrams KR, Mayberry JF. The risk of colorectal cancer in ulcerative colitis: a meta-analysis. Gut. 2001 Apr;48(4):526-35. doi: 10.1136/gut.48.4.526.
Provenzale D, Onken J. Surveillance issues in inflammatory bowel disease: ulcerative colitis. J Clin Gastroenterol. 2001 Feb;32(2):99-105. doi: 10.1097/00004836-200102000-00003.
Kornbluth Am J Gastroenterology 2004 Practice Guidelines for UC in adults as an additional reference
Rubin CE, Haggitt RC, Burmer GC, Brentnall TA, Stevens AC, Levine DS, Dean PJ, Kimmey M, Perera DR, Rabinovitch PS. DNA aneuploidy in colonic biopsies predicts future development of dysplasia in ulcerative colitis. Gastroenterology. 1992 Nov;103(5):1611-20. doi: 10.1016/0016-5085(92)91185-7.
Taylor BA, Pemberton JH, Carpenter HA, Levin KE, Schroeder KW, Welling DR, Spencer MP, Zinsmeister AR. Dysplasia in chronic ulcerative colitis: implications for colonoscopic surveillance. Dis Colon Rectum. 1992 Oct;35(10):950-6. doi: 10.1007/BF02253497.
Rembacken BJ, Fujii T, Cairns A, Dixon MF, Yoshida S, Chalmers DM, Axon AT. Flat and depressed colonic neoplasms: a prospective study of 1000 colonoscopies in the UK. Lancet. 2000 Apr 8;355(9211):1211-4. doi: 10.1016/s0140-6736(00)02086-9.
Kudo S, Tamura S, Nakajima T, Yamano H, Kusaka H, Watanabe H. Diagnosis of colorectal tumorous lesions by magnifying endoscopy. Gastrointest Endosc. 1996 Jul;44(1):8-14. doi: 10.1016/s0016-5107(96)70222-5.
Kiesslich R, Fritsch J, Holtmann M, Koehler HH, Stolte M, Kanzler S, Nafe B, Jung M, Galle PR, Neurath MF. Methylene blue-aided chromoendoscopy for the detection of intraepithelial neoplasia and colon cancer in ulcerative colitis. Gastroenterology. 2003 Apr;124(4):880-8. doi: 10.1053/gast.2003.50146.
Rutter MD, Saunders BP, Schofield G, Forbes A, Price AB, Talbot IC. Pancolonic indigo carmine dye spraying for the detection of dysplasia in ulcerative colitis. Gut. 2004 Feb;53(2):256-60. doi: 10.1136/gut.2003.016386.
Kara MA, Peters FP, Ten Kate FJ, Van Deventer SJ, Fockens P, Bergman JJ. Endoscopic video autofluorescence imaging may improve the detection of early neoplasia in patients with Barrett's esophagus. Gastrointest Endosc. 2005 May;61(6):679-85. doi: 10.1016/s0016-5107(04)02577-5.
Haringsma J, Tytgat GN. The value of fluorescence techniques in gastrointestinal endoscopy: better than the endoscopist's eye? I: The European experience. Endoscopy. 1998 May;30(4):416-8. doi: 10.1055/s-2007-1001292. No abstract available.
Nakayoshi T, Tajiri H, Matsuda K, Kaise M, Ikegami M, Sasaki H. Magnifying endoscopy combined with narrow band imaging system for early gastric cancer: correlation of vascular pattern with histopathology (including video). Endoscopy. 2004 Dec;36(12):1080-4. doi: 10.1055/s-2004-825961.
Hamamoto Y, Endo T, Nosho K, Arimura Y, Sato M, Imai K. Usefulness of narrow-band imaging endoscopy for diagnosis of Barrett's esophagus. J Gastroenterol. 2004 Jan;39(1):14-20. doi: 10.1007/s00535-003-1239-z.
Machida H, Sano Y, Hamamoto Y, Muto M, Kozu T, Tajiri H, Yoshida S. Narrow-band imaging in the diagnosis of colorectal mucosal lesions: a pilot study. Endoscopy. 2004 Dec;36(12):1094-8. doi: 10.1055/s-2004-826040.
Toruner M, Harewood GC, Loftus EV Jr, Sandborn WJ, Tremaine WJ, Faubion WA, Schroeder KW, Egan LJ. Endoscopic factors in the diagnosis of colorectal dysplasia in chronic inflammatory bowel disease. Inflamm Bowel Dis. 2005 May;11(5):428-34. doi: 10.1097/01.mib.0000158951.54388.3a.
Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981 Jun;2(2):93-113. doi: 10.1016/0197-2456(81)90001-5.
Riddell RH, Goldman H, Ransohoff DF, Appelman HD, Fenoglio CM, Haggitt RC, Ahren C, Correa P, Hamilton SR, Morson BC, et al. Dysplasia in inflammatory bowel disease: standardized classification with provisional clinical applications. Hum Pathol. 1983 Nov;14(11):931-68. doi: 10.1016/s0046-8177(83)80175-0.
Other Identifiers
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5-06
Identifier Type: -
Identifier Source: org_study_id
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