WASP Classification in Diagnosis of Diminutive Colorectal Polyps

NCT ID: NCT03903497

Last Updated: 2022-05-18

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

Clinical Phase

NA

Total Enrollment

2640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2023-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diminutive Colorectal Polyps

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Colonoscopy with NBI using the WASP classification
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Endoscopists did not know histology of diminutive colorectal polyps

Study Groups

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NBI assessment using the WASP classification

Group Type OTHER

NBI

Intervention Type DEVICE

optical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment

Interventions

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NBI

optical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Jilin People's Hospital

UNKNOWN

Sponsor Role collaborator

Wafangdian Third Hospital

UNKNOWN

Sponsor Role collaborator

Dezhou People's Hospital

OTHER

Sponsor Role collaborator

Liaocheng People's Hospital

OTHER

Sponsor Role collaborator

Wenzhou Central Hospital

OTHER

Sponsor Role collaborator

Yichun People's Hospital

UNKNOWN

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Shenzhen Baoan People's Hospital

UNKNOWN

Sponsor Role collaborator

Xinxiang Central Hospital

OTHER

Sponsor Role collaborator

Wuwei Cancer Hospital

UNKNOWN

Sponsor Role collaborator

Zunyi Medical College

OTHER

Sponsor Role collaborator

Yaan People's Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zhizheng Ge

MD,Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhi-Zheng Ge

Role: CONTACT

021-58752345

Facility Contacts

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Shu-Tian Zhang

Role: primary

Zhi-Zheng Ge

Role: primary

021-58752345

Other Identifiers

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rj[2018]086

Identifier Type: -

Identifier Source: org_study_id

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