- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03351257
The Characterization of Small and Diminutive Colonic Polyps in LCI
November 20, 2017 updated by: Affiliated Hospital to Academy of Military Medical Sciences
Linked Color Imaging vs White-light Colonoscopy in the Characterization of Small and Diminutive Colon Polyps
Colorectal cancer is a maior cause of morbidity and mortality worldwide.Colonoscopy and removal of all adenomas is the most efficient method to prevent colorectal cancer.The most colorectal polyps detected are small(<10mm) and diminutive(≦5mm) during colonoscopy.At that size,the are overwhelmingly hyperplastic or adenomatous,and rarely harbour high-grade dysplasia,cancer or sessile serrated adenoma/polyp.Traditional white-light endoscopy cannot reliably distinguish between small adenomatous and hyperplastic polyps,thus,real-time recognition of the polyp histology during colonoscopy has the potential to minimize both the costs and complications associated with endoscopic biopsy and polpectomy.Linked color imaging(LCI),a new system for endoscopy modality,creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of magnifying blue laser imaging(BLI) technology.
it is easier to recognize a slight difference in color of the mucosa.
This is a study to investigate the impact of Linked color imaging endoscopes on the in vivo histology prediction of colonic polyps.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
This is a prospective study comparing the accuracy of linked color imaging(LCI) and standard white light colonoscopes in the diagnosis of small and diminutive colorectal polyps.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pei Deng, Ph.M
- Phone Number: +86 01066947473
- Email: dengpei1983@21cn.com
Study Contact Backup
- Name: Min Min, Ph.D
- Phone Number: +86 01066947473
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Affiliated Hospital to Academy of Military Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Consecutive adult patients who were referred for elective outpatient colonoscopy will be asked to enroll into this trial if the candidate meets the study inclusion and exclusion criteria.
Description
Inclusion Criteria:
- 1.ability to provide written informed consent and undergoing colonoscopy. 2.The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up.
3.detection and retrieval for histologic examination of at least one polyp< 10mm in size and/or 5mm in size
Exclusion Criteria:
- Patients were previous colon resection
- Patients were a diagnosis of inflammatory bowel disease,familial polyp syndromes or poor bowel preparation
- suspected chronic stricture potentially precluding complete colonoscopy
- Patients had polypectomy or had coagulopathy/thrombocytopenia
- Patients had diverticulitis or toxic megacolon;previous radiation therapy to the abdomen or pelvis;severe cardiovascular,pulmonary,liver,or renal disease;and coagulation disorders or use of anticoagulants.
- all of polyps could influence surface pattern or/and color assessment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the accuracy of predicted in vivo polyp histology
Time Frame: 5 months
|
the accuracy of predicted in vivo polyp histology
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity
Time Frame: 5 months
|
Sensitivity of white light endoscopy in predicting histology
|
5 months
|
specificity
Time Frame: 5 months
|
sensitivity of white light endoscopy in predicting histology
|
5 months
|
Sensitivity
Time Frame: 5 months
|
Sensitivity of LCI endoscopy in predicting histology
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Longcroft-Wheaton G, Brown J, Cowlishaw D, Higgins B, Bhandari P. High-definition vs. standard-definition colonoscopy in the characterization of small colonic polyps: results from a randomized trial. Endoscopy. 2012 Oct;44(10):905-10. doi: 10.1055/s-0032-1310004. Epub 2012 Aug 14.
- Repici A, Hassan C, Radaelli F, Occhipinti P, De Angelis C, Romeo F, Paggi S, Saettone S, Cisaro F, Spaander M, Sharma P, Kuipers EJ. Accuracy of narrow-band imaging in predicting colonoscopy surveillance intervals and histology of distal diminutive polyps: results from a multicenter, prospective trial. Gastrointest Endosc. 2013 Jul;78(1):106-14. doi: 10.1016/j.gie.2013.01.035. Epub 2013 Apr 11.
- Lee CK, Lee SH, Hwangbo Y. Narrow-band imaging versus I-Scan for the real-time histological prediction of diminutive colonic polyps: a prospective comparative study by using the simple unified endoscopic classification. Gastrointest Endosc. 2011 Sep;74(3):603-9. doi: 10.1016/j.gie.2011.04.049. Epub 2011 Jul 18.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2017
Primary Completion (ANTICIPATED)
March 30, 2018
Study Completion (ANTICIPATED)
March 30, 2018
Study Registration Dates
First Submitted
November 20, 2017
First Submitted That Met QC Criteria
November 20, 2017
First Posted (ACTUAL)
November 22, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 22, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 307LCI-DCPs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Small Colon Polyps
-
IRCCS San RaffaeleUnknown
-
Biotax Labs LTDRecruiting
-
Seoul National University HospitalCompletedColon PolypKorea, Republic of
-
Portuguese Oncology Institute, CoimbraCompleted
-
Milton S. Hershey Medical CenterCompletedColon Cancer | Colon Adenoma | Colon PolypUnited States
-
London North West Healthcare NHS TrustCompletedColon PolypUnited Kingdom
-
Soonchunhyang University HospitalUnknownColon PolypKorea, Republic of
-
Ningbo No. 1 HospitalNot yet recruiting
-
Lumendi, LLCWeill Medical College of Cornell UniversityCompleted
-
VA Northern California Health Care SystemCompleted
Clinical Trials on observation of surface patterns and colors of polyps
-
Portsmouth Hospitals NHS TrustCompletedColonic PolypsUnited Kingdom
-
Technical University of MunichUnknown
-
Technical University of MunichChair of Computer Aided Medical Procedures & Augmented Reality; Institut...Unknown
-
Cosmo Technologies LtdCompletedPolyp and Adenoma Detection During Colonoscopy
-
Valduce HospitalCompletedColonic Polyps | Endoscopic Assessment | Endoscopic Surveillance | NBIItaly
-
University of BergenEuropean Society of Intensive Care MedicineCompletedCritical Illness | Old Age; Debility | SurvivalNorway
-
Ullevaal University HospitalUnknown
-
Universitaire Ziekenhuizen KU LeuvenCompletedLynch Syndrome | Hereditary Non-polyposis Colon Carcinoma | HNPCCBelgium
-
Hospices Civils de LyonCompleted