The Real-time Optical Diagnosis Value of Optical Enhancement Endoscopy in Colorectal Sessile Serrated Adenomas/Polyps

The Real-time Optical Diagnosis Value of Optical Enhancement Endoscopy in Colorectal Sessile Serrated Adenomas/Polyps :A Prospective Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03238573

Enrollment

Registered

2017-08-03

Start date

2017-07-19

Completion date

2019-12-01

Last updated

2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Sessile Serrated Adenomas/Polyps

Keywords

Colorectal Sessile Serrated Adenomas/Polyps optical enhancement endoscopy

Brief summary

When a polyp is found, we begin to wash it and observe it with OE mode 1.Then,the endoscopist gives a real-time optical diagnosis and the future surveillance interval.Finally,the polyp will be resected for the biopsy.

Detailed description

When discovering a polyp, the endoscopist uses water to wash it.Then, the endoscopist starts with i-scan 1 (OE mode 1) to observe the polyp closely .Nextly, the endoscopist give a real-time optical diagnosis with the blind of the history of patient. Considering the other polyps, the endoscopist gives a surveillance interval predictions according to the guide made by USMSTF.The confidence of the real-time optical diagnosis is divided into high confidence and low confidence.After the observation, the small and diminutive polyp will be resected and have the blinded pathology.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. The high risk for colorectal cancer screening score 2. Patients with colorectal polyps reviewing

Exclusion criteria

* 1.Inflammatory bowel disease 2. Polyposis syndrome 3. A history of colorectal cancer or surgical resection 4. Poor bowel preparation5.Not signing the informed consent 6.Severe cardiopulmonary function failure lesions, severe hypertension, cerebrovascular disease, mental disorder and coma, pregnancy, lactation can't taking the colonoscopy.

Design outcomes

Primary

Measure	Time frame
Real-time diagnosis accuracy of optical enhancement in colorectal sessile serrated adenomas/polyps	2years

Secondary

Measure	Time frame
Real-time diagnosis accuracy of optical enhancement in colorectal adenomas and hyperplastic polyps	2 years

Countries

China

Contacts

Primary ContactYanqing Li, MD,PhD

liyanqing@sdu.edu.cn86-531-82169236

Outcome results