Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study

Colonic Polyps Clinical Trial

— VALID  

Official title:

Real Time Colorectal Polyp Diagnosis in Colorectal Cancer Screening Using Close Focus High Definition Narrow Band Imaging Colonoscopy Compared to Conventional Histopathology Diagnosis - the VALID (Veterans Affairs Lesion Interpretation and Diagnosis) Colonoscopy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288833
• Other study ID #: VALID PA19624
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: October 2015

Study information

• Verified date: April 2018
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that high definition colonoscopy with close focus narrow band imaging features has a high diagnostic accuracy for colorectal polyp histology, and can replace formal pathologic assessment in cases of high diagnostic confidence.

Description:

A recent single arm prospective cohort study suggested that high definition colonoscopy with narrow band imaging is an acceptable strategy to diagnose polyp histology and determine future surveillance intervals. Endoscopic proficiency in macroscopic features to differentiate polyp histology can be attained in a relatively short time period. A new high definition colonoscope with close focus narrow band imaging features may further improve diagnostic accuracy for polyp differentiation, and can replace formal pathologic assessment in cases of high diagnostic confidence.

Primary Aim: Compare the diagnostic accuracy of high definition narrow band imaging colonoscopy with and without close focus features for the macroscopic differentiation of neoplastic and non-neoplastic colorectal lesions using histopathologic diagnosis as the reference standard.

Secondary Aims: Compare diagnostic characteristics of the colonoscopes, measure concordance of high confidence and accuracy, compare accuracy of predicted versus actual surveillance interval recommendations, perform a cost-effective analysis of endoscopic versus pathologic diagnoses, and measure complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients referred for routine colonoscopy

Exclusion Criteria:

• Known inflammatory bowel disease

• Personal or family history of polyposis or non-polyposis syndrome

• Presentation for emergency endoscopy

• Inability to remove polyp due to coagulopathy or thrombocytopenia

• Inability to provide informed consent

Related Conditions & MeSH terms

• Colonic Polyps
• Colorectal Neoplasm
• Colorectal Neoplasms
• Polyps

Intervention

Device:
• Close focus HD NBI Colonoscopy System
Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.

Locations

Country	Name	City	State
United States	Veterans Affairs Kansas City	Kansas City	Missouri
United States	Veterans Affairs Palo Alto	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	Kansas City Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10. — View Citation

Kaltenbach T, Sano Y, Friedland S, Soetikno R; American Gastroenterological Association. American Gastroenterological Association (AGA) Institute technology assessment on image-enhanced endoscopy. Gastroenterology. 2008 Jan;134(1):327-40. Epub 2007 Oct 30. Review. — View Citation

Muto M, Katada C, Sano Y, Yoshida S. Narrow band imaging: a new diagnostic approach to visualize angiogenesis in superficial neoplasia. Clin Gastroenterol Hepatol. 2005 Jul;3(7 Suppl 1):S16-20. Review. — View Citation

Raghavendra M, Hewett DG, Rex DK. Differentiating adenomas from hyperplastic colorectal polyps: narrow-band imaging can be learned in 20 minutes. Gastrointest Endosc. 2010 Sep;72(3):572-6. doi: 10.1016/j.gie.2010.03.1124. Epub 2010 Jun 19. — View Citation

Rastogi A, Keighley J, Singh V, Callahan P, Bansal A, Wani S, Sharma P. High accuracy of narrow band imaging without magnification for the real-time characterization of polyp histology and its comparison with high-definition white light colonoscopy: a prospective study. Am J Gastroenterol. 2009 Oct;104(10):2422-30. doi: 10.1038/ajg.2009.403. Epub 2009 Jul 7. — View Citation

Rex DK, Fennerty MB, Sharma P, Kaltenbach T, Soetikno R. Bringing new endoscopic imaging technology into everyday practice: what is the role of professional GI societies? Polyp imaging as a template for moving endoscopic innovation forward to answer key clinical questions. Gastrointest Endosc. 2010 Jan;71(1):142-6. doi: 10.1016/j.gie.2009.09.011. Epub 2009 Nov 17. — 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	Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups.	Measure of the percentage of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without close focus features. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology Note: one patient may have multiple polyps.	At the time of procedure
Secondary	Cost	Measure the cost of colonoscopy with macroscopic histopathologic diagnosis of colorectal lesions compared to colonoscopy with conventional microscopic histopathologic diagnosis, on the lesions that were managed based on an accurate endoscopic diagnosis.; A reduction in pathology specimens may improve the efficiency of the procedure and has direct pathology cost savings (as well as indirect savings, which were not measured).	At the time of procedure
Secondary	Diagnostic Characteristics	Compare the diagnostic characteristics (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without close focus features.; Accuracy: number of endoscopic predictions of adenomatous polyps histologically confirmed to be adenomatous/number of predicted hyperplastic polyps confirmed to be hyperplastic out of all polyps Sensitivity: number of endoscopic predictions (optical diagnosis) of adenomatous (neoplastic) polyps out of all histologically confirmed polyps Specificity: number of endoscopic predictions of hyperplastic (non-neoplastic) polyps out of all histologically confirmed polyps PPV: number of histologically confirmed adenomatous polyps out of all endoscopic predictions of adenomatous polyps NPV: number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps Note: a patient may have multiple polyps	At time of procedure
Secondary	Accuracy of Predicted Versus Actual Surveillance Intervals	Compared the accuracy of predicted versus actual surveillance colonoscopy interval recommendations by determining number of patients with correct surveillance interval recommendation.	At the time of procedure
Secondary	Learning Curve	Examine the impact of a learning curve (i.e. NPV of high confidence at each of endoscopist's first 50% of exams versus last 50% exams to endoscopically predict polyp histology). NPV is defined as "number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps.	At time of procedure.