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Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521091
First Posted: January 30, 2012
Last Update Posted: January 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xiaobo Li, Shanghai Jiao Tong University School of Medicine
  Purpose
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.

Condition
Colorectal Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions Using Magnifying Colonoscopy With Narrow Band Imaging, Indigo Carmine, and Acetic Acid Staining

Further study details as provided by Xiaobo Li, Shanghai Jiao Tong University School of Medicine:

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.


Enrollment: 565
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521091


Locations
China
Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200001
Sponsors and Collaborators
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
  More Information

Responsible Party: Xiaobo Li, Shanghai Institute of Digestive Disease,Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01521091     History of Changes
Other Study ID Numbers: rjxhnk01
First Submitted: January 24, 2012
First Posted: January 30, 2012
Last Update Posted: January 30, 2012
Last Verified: January 2012

Keywords provided by Xiaobo Li, Shanghai Jiao Tong University School of Medicine:
narrow band imaging(NBI)
indigo carmine
acetic acid
colorectal lesions
predicting histology

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases