WASP Classification in Diagnosis of Diminutive Colorectal... | NCT03903497

Studies
WASP Classification in Diagnosis of Diminutive Colorectal Polyps

NCT03903497

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

May 18, 2022Actual

Enrollment

2,640Estimated

Phase

Not Applicable

Conditions

Diminutive Colorectal Polyps

Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2019Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

May 30, 2023Estimated

First Submitted Date

Apr 1, 2019

First Submission Date that Met QC Criteria

Apr 3, 2019

First Posted Date

Apr 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2022

Last Update Posted Date

May 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhizheng Ge, MD,Ph.D, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Name	Class
Beijing Friendship Hospital	OTHER
Jilin People's Hospital	UNKNOWN
Wafangdian Third Hospital	UNKNOWN
Dezhou People's Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,640Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NBI assessment using the WASP classification	Other		Device: NBI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NBI	Device	optical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment	NBI assessment using the WASP classification

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhi-Zheng Ge	Contact	021-58752345		zhizhengge@aliyun.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friendship Hospital	Recruiting	Beijing	Beijing Municipality	100050	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Endoscopists did not know histology of diminutive colorectal polyps

Who Masked

Not provided