NCT03903497

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

April 1, 2019

Last Update Submit

May 17, 2022

Conditions

Diminutive Colorectal Polyps

Keywords

Narrow band imagingWASP classificationDiminutive colorectal polyps

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

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

    Within two weeks after polypectomy

Study Arms (1)

NBI assessment using the WASP classification

OTHER
Device: NBI

Interventions

NBIDEVICE

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

NBI assessment using the WASP classification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Central Study Contacts

Zhi-Zheng Ge

CONTACT

021-58752345zhizhengge@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Endoscopists did not know histology of diminutive colorectal polyps
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Colonoscopy with NBI using the WASP classification
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,Ph.D

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 4, 2019

Study Start

April 15, 2019

Primary Completion

December 30, 2022

Study Completion

May 30, 2023

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)