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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiaobo Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01521104
First received: January 25, 2012
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of invasive depth of colorectal neoplasia.


Condition
Colorectal Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Value of NBI in Stratifying Patients for Endoscopic Resection or Surgery

Resource links provided by NLM:


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

Biospecimen Retention:   Samples Without DNA

All the lesions will be removed endoscopically or surgically and examined 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:

NBI could be used in stratifying patients for endoscopic resection or surgery and got an accurate evaluation.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

consecutive adult patients undergo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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: NCT01521104     History of Changes
Other Study ID Numbers: rjxhnk02
Study First Received: January 25, 2012
Last Updated: January 27, 2012
Health Authority: China: Ethics Committee
China: Ministry of Health

Keywords provided by Shanghai Jiao Tong University School of Medicine:
narrow band imaging(NBI)
colorectal lesions
predicting histology

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

ClinicalTrials.gov processed this record on September 14, 2014