Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

565 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery

NCT01521104

Colorectal Neoplasms

COMPLETED

Diagnosis of Colonic Adenomas by Bright Narrow Band Imaging (B-NBI)

NCT01422577

Colonic Adenomas

COMPLETED NA

Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI

NCT02047188

Colorectal Neoplasms

COMPLETED

The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions

NCT01431703

Colorectal Lesion

COMPLETED

A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions

NCT02968069

Early Gastric Cancer

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiaobo Li

Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xiaobo Li, MD. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai, China