Clinical trial NCT03351257: The Characterization of Small and Diminutive Colonic Polyps in LCI
Official title: Linked Color Imaging vs White-light Colonoscopy in the Characterization of Small and Diminutive Colon Polyps
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Colon Polyps
Linked Color Imagimg
Diminutive Colon Polyps
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the accuracy of predicted in vivo polyp histology
timeFrame: 5 months
Secondary outcomes:
measure: Sensitivity
timeFrame: 5 months
measure: specificity
timeFrame: 5 months
measure: Sensitivity
timeFrame: 5 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital to Academy of Military Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Affiliated Hospital to Academy of Military Medical Sciences
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.