Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis

NCT00587236 | Completed

• 1 other identifier: 5-06
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to: 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.

Conditions

Colitis, Ulcerative; Cholangitis, Sclerosing

Keywords

Autofluorescence; Narrow Band; High definition white light

Outcome Measures

Primary Outcomes (1)

• Compare the dysplasia detection rate between scope modalities and biopsy type; surveillance or targeted biopsies in CUC patients with concurrent PSC.

  Two years

Secondary Outcomes (1)

• Assess the impact of patient related factors on the difference in dysplasia detection rate between while light colonoscopy and the AFI and NBI techniques in patients with CUC and concurrent PSC.

  Two years.

Study Arms (2)

1

Patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis.

2

Patients with chronic ulcerative colitis and known dysplasia or cancer.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with chronic ulcerative colitis and Primary sclerosing cholangitis and/or patients with chronic ulcerative colitis and known colorectal dysplasia or cancer needing a surveillance colonoscopy.

You may qualify if:

• patients requiring a clinically indicated surveillance colonoscopy
• able to give informed written consent
• history of chronic ulcerative colitis and colonic dysplasia/or cancer or primary sclerosing cholangitis

You may not qualify if:

• patients with known colonic obstruction
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (17)

• 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.

  PMID: 11247898 BACKGROUND

• 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.

  PMID: 11205664 BACKGROUND

• Kornbluth Am J Gastroenterology 2004 Practice Guidelines for UC in adults as an additional reference

  BACKGROUND

• 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.

  PMID: 1426881 BACKGROUND

• 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.

  PMID: 1395982 BACKGROUND

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  PMID: 10770302 BACKGROUND

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  PMID: 8836710 BACKGROUND

• 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.

  PMID: 12671882 BACKGROUND

• 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.

  PMID: 14724160 BACKGROUND

• 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.

  PMID: 15855971 BACKGROUND

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  PMID: 9689518 BACKGROUND

• 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.

  PMID: 15578298 BACKGROUND

• 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.

  PMID: 14767729 BACKGROUND

• 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.

  PMID: 15578301 BACKGROUND

• 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.

  PMID: 15867581 BACKGROUND

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  PMID: 7273794 BACKGROUND

• 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.

  PMID: 6629368 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Cholangitis; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• Christopher J Gostout, MD

  Mayo Clinic, Rochester, MN

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: March 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)