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The Characterization of Small and Diminutive Colonic Polyps in LCI

NCT ID: NCT03351257

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-03-30

Brief Summary

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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

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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.

Conditions

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Small Colon Polyps Linked Color Imagimg Diminutive Colon Polyps

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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observation of surface patterns and colors of polyps

examination of the surface patterns and colors of polyps using Linked color imaging and white-light

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pei Deng, Ph.M

Role: CONTACT

Phone: 01066947473

Email: [email protected]

Min Min, Ph.D

Role: CONTACT

Phone: 01066947473

Facility Contacts

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Pei Deng, Ph.M

Role: primary

Min min, Ph.D

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22893132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23582472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21762907 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/26448409

diminutive colonic polyps

Other Identifiers

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307LCI-DCPs

Identifier Type: -

Identifier Source: org_study_id