Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions
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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 |
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) |
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
consecutive adult patients undergoing colonoscopy and find out more than one lesion ≧ 6mm from Jan 2009 to Dec 2010.
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| China | |
| Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine | |
| Shanghai, China, 200001 | |
| 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
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: | NCT01521091 History of Changes |
| Other Study ID Numbers: | rjxhnk01 |
| Study First Received: | January 24, 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） indigo carmine acetic acid 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 May 19, 2013