WASP Classification in Diagnosis of Diminutive Colorectal Polyps

Efficacy of WASP Classification in the Histological Evaluation of Diminutive Colorectal Polyps

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.

Study Overview

• Status: Recruiting
• Conditions: Diminutive Colorectal Polyps
• Intervention / Treatment: Device: NBI

• Study Type: Interventional
• Enrollment (Anticipated): 2640
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhi-Zheng Ge; Phone Number: 021-58752345; Email: zhizhengge@aliyun.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Shu-Tian Zhang
      • Principal Investigator: Shu-Tian Zhang, MD
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Recruiting
      • RenJi Hospital
      • Contact: Zhi-Zheng Ge; Phone Number: 021-58752345; Email: zhizhengge@aliyun.com
      • Principal Investigator: Zhi-Zheng Ge, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NBI assessment using the WASP classification	Device: NBI; optical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Accuracy of Surveillance time prediction of patients with at least one diminutive polyps under high confidence of diagnosis	Within two weeks after polypectomy
Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis	Within two weeks after polypectomy
Accuracy of WASP classification in histological prediction of diminutive polyps under high confidence of diagnosis	Within two weeks after polypectomy

Secondary Outcome Measures

Outcome Measure	Time Frame
Learning curve of accuracy of endoscopists using NBI in assessment of diminutive polyps	Within two weeks after polypectomy

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Beijing Friendship Hospital; The Third Xiangya Hospital of Central South University; Wenzhou Central Hospital; Zunyi Medical College; Liaocheng People's Hospital; Dezhou People's Hospital; Jilin People's Hospital; Wafangdian Third Hospital; Yichun People's Hospital; Shenzhen Baoan People's Hospital; Xinxiang Central Hospital; Wuwei Cancer Hospital; Yaan People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Narrow band imaging; WASP classification; Diminutive colorectal polyps
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: rj[2018]086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No