Know Cancer

or
forgot password

Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon


N/A
50 Years
85 Years
Open (Enrolling)
Both
Colon Cancer

Thank you

Trial Information

Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon


This is a randomized controlled trial comparing the use of Narrow-Band Imaging (illumination
of the colon in blue light)versus standard white light for the detection of serrated lesions
in the proximal colon (the colon proximal to the splenic flexure). Recent studies have
indicated that colonoscopy is more effective in preventing cancer in the left side of the
colon than the right side of the colon. The reasons for this difference may be partly
biologic, in that a special group of polyps known as serrated polyps, particularly sessile
serrated adenomas, are located primarily proximal to the splenic flexure. These lesions
share molecular features with a group of cancers that occur primarily in the proximal colon.
These molecular features include CpG island methylator phenotype (CIMP) and microsatellite
instability. These lesions are endoscopically subtle in that they are often flat, have the
same color as the surrounding mucosa, and are hard to differentiate from normal mucosa.
Narrow-Band Imaging has anecdotally been used to highlight the appearance of these lesions.
This study will test whether Narrow-Band Imaging increases the detection of serrated lesions
in a randomized controlled trial.


Inclusion Criteria:



- Age 50-85

- Intact colon and rectum

- American Society of Anesthesiology risk class 1, 2 or 3

Exclusion Criteria:

- No prior surgical resection of colon or rectum

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Proximal Serrated lesions

Outcome Description:

Quantity of serrated lesions found in the proximal colon during colonoscopy.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Douglas K Rex, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

1012-17

NCT ID:

NCT01572428

Start Date:

April 2011

Completion Date:

December 2013

Related Keywords:

  • Colon Cancer
  • Proximal Colon Cancer
  • Serrated Colon Lesions
  • Narrow Band Imaging
  • Colonic Neoplasms

Name

Location

Beltway Surgical CenterIndianapolis, Indiana