Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon

NCT01572428 | Completed Results

• 1 other identifier: 1012-17
• Study Type: interventional
• Target: 898
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see with standard white light.

Conditions

Colon Cancer

Keywords

Proximal Colon Cancer; Serrated Colon Lesions; Narrow Band Imaging

Outcome Measures

Primary Outcomes (2)

• Total Number of Serrated Lesions Proximal to the Sigmoid Colon

  Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.

  During the colonoscopy procedure

• Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient

  Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).

  During the colonoscopy procedure

Secondary Outcomes (4)

• Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon

  During the colonoscopy procedure

• Total Number of Conventional Adenomas in Entire Colon

  During the colonoscopy procedure

• Number of Conventional Adenomas Per Patient in Entire Colon

  During the colonoscopy procedure

• Patients With 1 or More Conventional Adenomas

  During the colonoscopy procedure

Study Arms (2)

Narrow-Band Imaging (NBI)

ACTIVE COMPARATOR

Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)

Procedure: Inspection with Narrow-Band Imaging(NBI)

Standard White Light

ACTIVE COMPARATOR

Inspection with Standard White Light versus Narrow-Band Imaging(NBI)

Procedure: Inspection with Narrow-Band Imaging(NBI); Procedure: Standard White Light

Interventions

Inspection with Narrow-Band Imaging(NBI) PROCEDURE

Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.

Also known as: Colonoscopy

Narrow-Band Imaging (NBI); Standard White Light

Standard White Light PROCEDURE

Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.

Also known as: Colonoscopy

Standard White Light

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-85
• Intact colon and rectum
• American Society of Anesthesiology risk class 1, 2 or 3

You may not qualify if:

• No prior surgical resection of colon or rectum

Sponsors & Collaborators

• Indiana University: lead
• Olympus: collaborator

Study Sites (1)

Beltway Surgical Center

Indianapolis, Indiana, 46280, United States

Location

Related Publications (1)

• Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.

  PMID: 25952085 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Watchful Waiting; Narrow Band Imaging; Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Limitations and Caveats

Endoscopists weren't blinded to the type of light being used during withdrawal, which is a limitation of all detection studies. Number of SSPs were not specifically an endpoint of the study, but rather the entire serrated class of polyps.

Results Point of Contact

• Title: Rachel Lahr
• Organization: Indiana University

rlahr@iu.edu

317-948-0724

Study Officials

• Douglas K Rex, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: April 6, 2012
• Study Start: April 1, 2011
• Primary Completion: July 7, 2014
• Study Completion: July 7, 2014
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-06

Locations

US (1)