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

Colorectal Sessile Serrated Adenomas/Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03238573
• Other study ID #: 2017SDU-QILU-03
• Status: Recruiting
• Phase: N/A
• First received: August 1, 2017
• Last updated: August 1, 2017
• Start date: July 19, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2017
• Source: Shandong University
• Contact: Yanqing Li, MD,PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Sessile Serrated Adenomas/Polyps
• Polyps

Locations

Country	Name	City	State
China	Department of Gastroenterology,Qilu Hospital,Shandong University	Jin'an	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

References & Publications (3)

Erichsen R, Baron JA, Hamilton-Dutoit SJ, Snover DC, Torlakovic EE, Pedersen L, Frøslev T, Vyberg M, Hamilton SR, Sørensen HT. Increased Risk of Colorectal Cancer Development Among Patients With Serrated Polyps. Gastroenterology. 2016 Apr;150(4):895-902.e — View Citation

IJspeert JE, Bastiaansen BA, van Leerdam ME, Meijer GA, van Eeden S, Sanduleanu S, Schoon EJ, Bisseling TM, Spaander MC, van Lelyveld N, Bargeman M, Wang J, Dekker E; Dutch Workgroup serrAted polypS & Polyposis (WASP). Development and validation of the WA — View Citation

Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):8 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-time diagnosis accuracy of optical enhancement in colorectal sessile serrated adenomas/polyps		2years
Secondary	Real-time diagnosis accuracy of optical enhancement in colorectal adenomas and hyperplastic polyps		2 years