search
Back to results

WASP Classification in Diagnosis of Diminutive Colorectal Polyps

Primary Purpose

Diminutive Colorectal Polyps

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NBI
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diminutive Colorectal Polyps focused on measuring Narrow band imaging, WASP classification, Diminutive colorectal polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Friendship HospitalRecruiting
  • Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NBI assessment using the WASP classification

Arm Description

Outcomes

Primary Outcome Measures

Accuracy of Surveillance time prediction of patients with at least one diminutive polyps under high confidence of diagnosis
Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis
Accuracy of WASP classification in histological prediction of diminutive polyps under high confidence of diagnosis

Secondary Outcome Measures

Learning curve of accuracy of endoscopists using NBI in assessment of diminutive polyps

Full Information

First Posted
April 1, 2019
Last Updated
May 17, 2022
Sponsor
Shanghai Jiao Tong University School of Medicine
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, Zunyi Medical College, Yaan People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03903497
Brief Title
WASP Classification in Diagnosis of Diminutive Colorectal Polyps
Official Title
Efficacy of WASP Classification in the Histological Evaluation of Diminutive Colorectal Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
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, Zunyi Medical College, Yaan People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diminutive Colorectal Polyps
Keywords
Narrow band imaging, WASP classification, Diminutive colorectal polyps

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Colonoscopy with NBI using the WASP classification
Masking
None (Open Label)
Masking Description
Endoscopists did not know histology of diminutive colorectal polyps
Allocation
N/A
Enrollment
2640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NBI assessment using the WASP classification
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
NBI
Intervention Description
optical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment
Primary Outcome Measure Information:
Title
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
Title
Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis
Time Frame
Within two weeks after polypectomy
Title
Accuracy of WASP classification in histological prediction of diminutive polyps under high confidence of diagnosis
Time Frame
Within two weeks after polypectomy
Secondary Outcome Measure Information:
Title
Learning curve of accuracy of endoscopists using NBI in assessment of diminutive polyps
Time Frame
Within two weeks after polypectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-Zheng Ge
Phone
021-58752345
Email
zhizhengge@aliyun.com
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Tian Zhang
First Name & Middle Initial & Last Name & Degree
Shu-Tian Zhang, MD
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Zheng Ge
Phone
021-58752345
Email
zhizhengge@aliyun.com
First Name & Middle Initial & Last Name & Degree
Zhi-Zheng Ge, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

WASP Classification in Diagnosis of Diminutive Colorectal Polyps

We'll reach out to this number within 24 hrs