Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

Colonoscopy Clinical Trial

Official title:

Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133041
• Other study ID #: SCHCH2010L2
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2010
• Last updated: September 26, 2011
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: May 2010
• Source: Soon Chun Hyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax).

Several previous studies have indicated that NBI without magnification can be useful for real-time differentiation of diminutive colonic neoplasias.

To date, however, there are no studies comparing NBI with other imaging systems (FICE or i-Scan) for differentiation of diminutive colonic polyps.

The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in real-time prediction of diminutive colonic polyps.

In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will be observed with conventional colonoscopy, thereafter will be observed with new imaging systems.

Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by reference to histological results obtained by endoscopic biopsy or polypectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• screening or surveillance colonoscopy

• age over 18

• informed consent

Exclusion Criteria:

• history of inflammatory bowel diseases

• history of hereditary colorectal cancers and polyposis syndrome

• inability to give informed consent

• use of antiplatelet agent and anticoagulants

• pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenomatous Polyp
• Adenomatous Polyps
• Colonic Polyps
• Colonoscopy
• Diminutive Colon Polyp
• Hyperplasia
• Hyperplastic Polyp
• Polyps

Intervention

Other:
• Observation using NBI system
NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
• Observation using i-Scan system
I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.

Locations

Country	Name	City	State
Korea, Republic of	Soon Chung Hyang University, Cheonan hospital	Cheonan	Choongnam

Sponsors (1)

Lead Sponsor	Collaborator
Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Hoffman A, Kagel C, Goetz M, Tresch A, Mudter J, Biesterfeld S, Galle PR, Neurath MF, Kiesslich R. Recognition and characterization of small colonic neoplasia with high-definition colonoscopy using i-Scan is as precise as chromoendoscopy. Dig Liver Dis. 2010 Jan;42(1):45-50. doi: 10.1016/j.dld.2009.04.005. Epub 2009 May 26. — View Citation

Rastogi A, Pondugula K, Bansal A, Wani S, Keighley J, Sugar J, Callahan P, Sharma P. Recognition of surface mucosal and vascular patterns of colon polyps by using narrow-band imaging: interobserver and intraobserver agreement and prediction of polyp histology. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):716-22. doi: 10.1016/j.gie.2008.09.058. — View Citation

Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic efficacy	Sensitivity, specificity, and diagnostic accuracy	about 1 year	No