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WASP Classification in Diagnosis of Diminutive Colorectal Polyps

S

Shanghai Jiao Tong University School of Medicine

Status

Unknown

Conditions

Diminutive Colorectal Polyps

Treatments

Device: NBI

Study type

Interventional

Funder types

Other

Identifiers

NCT03903497
rj[2018]086

Details and patient eligibility

About

Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. Some studies have investigated the value of the narrow-band imaging (NBI) on histological prediction of the polyp. This method is conducted in real time during colonoscopy, which leads to simplification of diagnostic procedures. For instance, it would be conceivable to resect diminutive polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.

In this study the investigators want to investigate whether the use of NBI would be capable to get accuracy of optical polyp predictions by more than 90% using the WASP (Workgroup serrAted polypS and Polyposis) classification. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial the investigators aim to compare accuracy of the optical diagnosis.

Enrollment

2,640 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged more than 18 years old
  • Patients with at least one diminutive colorectal polyp

Exclusion criteria

  • Patients with poor bowel preparation
  • Paitents with history of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
  • Patients with advanced colorectal cancer
  • Patients with missed histology information of resected polyps or missed resected specimen
  • Patients with emergency operation during colonoscopy
  • Patients with unfinished colonoscopy due to any reason

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2,640 participants in 1 patient group

NBI assessment using the WASP classification
Other group
Treatment:
Device: NBI

Trial contacts and locations

2

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Central trial contact

Zhi-Zheng Ge

Data sourced from clinicaltrials.gov

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