Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions

September 27, 2025 updated by: Xiaobo Li, Shanghai Jiao Tong University School of Medicine

Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions Using Magnifying Colonoscopy With Narrow Band Imaging, Indigo Carmine, and Acetic Acid Staining

Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be the first choice.

Study Overview

Status

Completed

Conditions

Detailed Description

To compare the diagnostic accuracy of chromoendoscopy indigo carmine or acetic acid and NBI for differentiating neoplastic from non-neoplastic colorectal lesions, differentiating adenomas from carcinomas, and differentiating early carcinomas from invasive ones.

Included colorectal lesions consecutively distribute in a 1:1 ratio to 2 groups.

Study Type

Observational

Enrollment (Actual)

565

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200001
        • Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

consecutive adult patients undergoing colonoscopy and find out more than one lesion ≧ 6mm from Jan 2009 to Dec 2010.

Description

Inclusion Criteria:

  • Consecutive patients with more than one lesion ≧ 6mm .

Exclusion Criteria:

  • Patients with chronic inflammatory bowel disease, advanced cancer, insufficient bowel preparation, familial adenomatous polyposis (FAP)
  • Lesions ≦ 5mm and submucosal tumor (SMT).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Xiaobo Li, MD. Ph.D, Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimated)

January 30, 2012

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 27, 2025

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjxhnk01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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