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

NCT01288833 | Completed Results DMC

• 1 other identifier: VALID PA19624
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colorectal Neoplasm; Colonic Polyps

Keywords

Colonoscopy; Diagnostic Imaging; Colorectal Neoplasm; Primary Prevention; Cost and Cost Analysis; Endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cost

  At the time of procedure

• Diagnostic Characteristics

  At time of procedure

• Accuracy of Predicted Versus Actual Surveillance Intervals

  At the time of procedure

• Learning Curve

  At time of procedure.

Study Arms (2)

Close focus HD NBI Colonoscopy System

EXPERIMENTAL

Use of close focus to make optical diagnosis

Device: Close focus HD NBI Colonoscopy System

Current HD NBI Colonoscopy System

NO INTERVENTION

Use of standard focus for optical diagnosis

Interventions

Close focus HD NBI Colonoscopy System DEVICE

Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.

Close focus HD NBI Colonoscopy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients referred for routine colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead
• Kansas City Veteran Affairs Medical Center: collaborator

Study Sites (2)

Veterans Affairs Palo Alto

Palo Alto, California, 94304, United States

Location

Veterans Affairs Kansas City

Kansas City, Missouri, 64128, United States

Location

Related Publications (10)

• 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. doi: 10.1053/j.gastro.2007.10.062. Epub 2007 Oct 30.

  PMID: 18061178 BACKGROUND

• 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. doi: 10.1016/s1542-3565(05)00262-4.

  PMID: 16012987 BACKGROUND

• 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.

  PMID: 19187781 BACKGROUND

• 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.

  PMID: 20561618 BACKGROUND

• 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.

  PMID: 19584829 BACKGROUND

• 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.

  PMID: 19910250 BACKGROUND

• 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. No abstract available.

  PMID: 19922926 BACKGROUND

• von Renteln D, Kaltenbach T, Rastogi A, Anderson JC, Rosch T, Soetikno R, Pohl H. Simplifying Resect and Discard Strategies for Real-Time Assessment of Diminutive Colorectal Polyps. Clin Gastroenterol Hepatol. 2018 May;16(5):706-714. doi: 10.1016/j.cgh.2017.11.036. Epub 2017 Nov 23.

  PMID: 29174789 DERIVED

• Kaltenbach T, Rastogi A, Rouse RV, McQuaid KR, Sato T, Bansal A, Kosek JC, Soetikno R. Real-time optical diagnosis for diminutive colorectal polyps using narrow-band imaging: the VALID randomised clinical trial. Gut. 2015 Oct;64(10):1569-77. doi: 10.1136/gutjnl-2014-307742. Epub 2014 Nov 11.

  PMID: 25387891 DERIVED

• McGill SK, Soetikno R, Rastogi A, Rouse RV, Sato T, Bansal A, McQuaid K, Kaltenbach T. Endoscopists can sustain high performance for the optical diagnosis of colorectal polyps following standardized and continued training. Endoscopy. 2015 Mar;47(3):200-6. doi: 10.1055/s-0034-1378096. Epub 2014 Sep 29.

  PMID: 25264764 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Tonya Kaltenbach
• Organization: San Francisco VA Medical Center

tonya.kaltenbach@va.gov

415-221-4810

Study Officials

• Tonya Kaltenbach, MD MS

  Veterans Affairs Palo Alto

  PRINCIPAL INVESTIGATOR

• Roy Soetikno, MD MS

  Veterans Affairs Palo Alto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 2, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 1, 2018
• Results First Posted: April 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)