Detection of Colorectal Adenoma by Optical Enhancement Te... | NCT02865382

Studies
Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy

NCT02865382

Sponsor

Yanqing Li

Status

Unknown status

Last Update Posted

Oct 12, 2016Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Colonic Polyps

Interventions

white light was used for colonoscopy withdrawal
OE mode was used for colonoscopy withdrawal

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Feb 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 9, 2016

First Posted Date

Aug 12, 2016Estimated

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

Oct 11, 2016

Last Update Posted Date

Oct 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Optical Enhancement Technology might be superior to the conventional HD-WL in detecting colorectal adenomas

Detailed Description

Colorectal cancer is the third most common cancer in the world.Colonoscopy is the gold standard screening test for colorectal cancer.There are also emerging data to support that screening by colonoscopy reduces both the incidence and mortality of colorectal cancer.However,Colonoscopy could still miss colorectal adenomas and even cancer.The miss rate for colonic adenomas was reported to be ranging from 15 to 32% in tandem colonoscopy studies.The reasons for the miss rate may be technical(insufficient during excessively fast instrument withdrawal),but may also be the imaging method.Smaller lesions ,particularly flat ones ,may be missed as a result of their subtle appearance and limited contrast in relation to the surrounding mucosa.

Some image-enhanced modules were developed with an aim to improve colorectal polyp or adenoma detection.The widely available modules is the narrow band imaging(NBI).However,most studies failed to demonstrate any superiority of NBI system over white light colonoscopy in detecting colonic polyps.NBI provides dimmer images of the colonic mucosa ,which may limit its performance on polyp and adenoma detection.

Like NBI,OE technology is image-enhanced module,providing a more intense look at the vascular pattern morphology.Besides,OE technology provides an much brighter image compared to NBI.This may possibly increase polyp detection by enhancing visibility of the colonic mucosa with brighter image.The current study aims to tested whether OE technology would improve adenoma detection when compared with high-definition colonoscopy.

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	white light was used for both insertion and withdrawal of the colonoscope	Procedure: white light was used for colonoscopy withdrawal
Group B	Experimental	Insertion to cecum was performed under white light and once the cecum was reached,the OE mode was swithed on during withdrawal of endoscope for complete colonic examination	Procedure: OE mode was used for colonoscopy withdrawal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
white light was used for colonoscopy withdrawal	Procedure		Group A
OE mode was used for colonoscopy withdrawal

Measure	Description	Time Frame
adenoma detection rate		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients were selected if they presented for diagnostic colonoscopy for a variety of indications(eg positive fecal occult blood test, abdominal pain, diarrhoea,post-polypectomy surveillance).

Exclusion Criteria:

Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome.
The cecum could not be intubated.
Inadequate bowel preparation (Aronchick Bowel Preparation Scale score poor or inadequate).
Biopsies were not available.
Unable to provide informed consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanqing Li, MD, PhD	Contact	86-531-82169236		liyanqing@sdu.edu.cn

Overall Officials

Name	Affiliation	Role
Yanqing Li, MD, PhD	Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University		Jinan	Shandong	250012	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17681999	Background	Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.
20628363

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms