Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions

NCT01521091 | Completed

• 1 other identifier: rjxhnk01
• Study Type: observational
• Target: 565
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Neoplasms

Keywords

narrow band imaging（NBI）; indigo carmine; acetic acid; colorectal lesions; predicting histology

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, 200001, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All the lesions will be removed endoscopically or surgically and examine histologically by an independent gastrointestinal pathologist. Histological diagnosis is determined according to the World Health Organization (WHO) criteria. Pedunculated lesions are categorized according to Haggitt's classification.

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 2, 2025

Record last verified: 2012-01

Locations

CN (1)