Clinical trial · Observational
Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis
A Blinded Comparison of Conventional Colonoscopy to Endoscopic AFI and NBI for Dysplasia Detection in Patients With Ulcerative Colitis and Sclerosing Cholangitis or Known Colorectal Dysplasia or Cancer- A Pilot Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangitis, Sclerosing | — | UNRESOLVED | — |
| Colitis, Ulcerative | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis.
- label
- 2
- description
- Patients with chronic ulcerative colitis and known dysplasia or cancer.
Primary outcomes (1)
- measure
- Compare the dysplasia detection rate between scope modalities and biopsy type; surveillance or targeted biopsies in CUC patients with concurrent PSC.
- timeFrame
- Two years
Secondary outcomes (1)
- measure
- 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.
- timeFrame
- Two years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (17)
- BACKGROUNDEaden 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
- BACKGROUNDProvenzale 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
- BACKGROUNDKornbluth Am J Gastroenterology 2004 Practice Guidelines for UC in adults as an additional reference
- BACKGROUNDRubin 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
- BACKGROUNDTaylor 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
- BACKGROUNDRembacken 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. PMID 10770302
- BACKGROUNDKudo 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. PMID 8836710
- BACKGROUNDKiesslich 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.