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

• Conditions: Colorectal Sessile Serrated Adenomas/Polyps

• Registration Number: NCT03238573
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2017-07-19
• Status Verified: 2017-08
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-01
• Last Update Submitted: 2017-08-01
• Study First Posted: 2017-08-03
• Last Update Posted: 2017-08-03
• Primary Completion: 2019-08-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Gastroenterology,Qilu Hospital,Shandong University; 🇨🇳 Jin'an, Shandong, China