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WASP Classification in Diagnosis of Diminutive Colorectal Polyps

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ClinicalTrials.gov Identifier: NCT03903497
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
Beijing Friendship Hospital
Jilin People's Hospital
Wafangdian Third Hospital
Dezhou People's Hospital
Liaocheng People's Hospital
Wenzhou Central Hospital
Yichun People's Hospital
The Third Xiangya Hospital of Central South University
Shenzhen Baoan People's Hospital
Xinxiang Central Hospital
Wuwei Cancer Hospital
Affiliated Hospital of Zunyi Medical University
Yaan People's Hospital
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diminutive Colorectal Polyps Device: NBI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2640 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Colonoscopy with NBI using the WASP classification
Masking: None (Open Label)
Masking Description: Endoscopists did not know histology of diminutive colorectal polyps
Primary Purpose: Diagnostic
Official Title: Efficacy of WASP Classification in the Histological Evaluation of Diminutive Colorectal Polyps
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
NBI assessment using the WASP classification Device: NBI
optical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment




Primary Outcome Measures :
  1. Accuracy of Surveillance time prediction of patients with at least one diminutive polyps under high confidence of diagnosis [ Time Frame: Within two weeks after polypectomy ]
  2. Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis [ Time Frame: Within two weeks after polypectomy ]
  3. Accuracy of WASP classification in histological prediction of diminutive polyps under high confidence of diagnosis [ Time Frame: Within two weeks after polypectomy ]

Secondary Outcome Measures :
  1. Learning curve of accuracy of endoscopists using NBI in assessment of diminutive polyps [ Time Frame: Within two weeks after polypectomy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903497


Contacts
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Contact: Zhi-Zheng Ge 021-58752345 zhizhengge@aliyun.com

Locations
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China, Beijing
Beijing Friendship Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Shu-Tian Zhang         
Principal Investigator: Shu-Tian Zhang, MD         
China, Shanghai
Renji Hospital Recruiting
Shanghai, Shanghai, China, 200001
Contact: Zhi-Zheng Ge    021-58752345    zhizhengge@aliyun.com   
Principal Investigator: Zhi-Zheng Ge, MD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Beijing Friendship Hospital
Jilin People's Hospital
Wafangdian Third Hospital
Dezhou People's Hospital
Liaocheng People's Hospital
Wenzhou Central Hospital
Yichun People's Hospital
The Third Xiangya Hospital of Central South University
Shenzhen Baoan People's Hospital
Xinxiang Central Hospital
Wuwei Cancer Hospital
Affiliated Hospital of Zunyi Medical University
Yaan People's Hospital
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Responsible Party: Zhizheng Ge, MD,Ph.D, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03903497    
Other Study ID Numbers: rj[2018]086
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine:
Narrow band imaging
WASP classification
Diminutive colorectal polyps
Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical