Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection | NCT02476747

Studies
Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection

NCT02476747

Sponsor

Asan Medical Center

Status

Unknown status

Last Update Posted

Jun 24, 2015Estimated

Enrollment

103Estimated

Phase

Not Applicable

Conditions

Colonic Polyp

Interventions

Countries

South Korea

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

Jun 2015

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

Jun 2015

Primary Completion Date

Sep 2015Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

Jun 17, 2015

First Submission Date that Met QC Criteria

Jun 17, 2015

First Posted Date

Jun 19, 2015Estimated

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

Jun 23, 2015

Last Update Posted Date

Jun 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6~10mm).

One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.

Detailed Description

With sized polyp from 6mm to less than 10mm, it has been classified by the previous studies as a "small polyp".

Their potential for advanced neoplasia is usually size-dependent, but some recent studies found that, even in diminutive and small polyps, the rate of advanced neoplasia is relatively high about 9%-10%.

The investigators will prospectively investigate postprocedural outcomes, such as retrieval rate, procedural time, overall complication rate (Intraprocedural bleeding, postprocedural bleeding, and perforation) in colonoscopic polypectomy of small polyp between CSP and EMR.

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

103Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cold snare polypectomy	Experimental	CSP will be performed by closing the snare loop after positioning the open snare at the point of lesion.	Other: CSP
Endoscopic mucosal resection	Active Comparator	EMR will be performed in the way of drawing the lesion into the loop of the snare and resecting followed by saline injection to the its margin.	Other: EMR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMR	Other	performing EMR for patients with small polyp	Endoscopic mucosal resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete resection rate (CRR)		Up to 2 months

Secondary Outcomes

Measure	Description	Time Frame
incidence of complications (Intraprocedural bleeding, postprocedural bleeding, and perforation)		Up to 2 months
necessity of hemostasis (due to Intraprocedural bleeding or postprocedural bleeding)		Up to 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)

Exclusion Criteria:

(1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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
Jeong-Sik Byeon, Doctor	Contact	82-2-3010-3905		jsbyeon@amc.seoul.kr

Overall Officials

Name	Affiliation	Role
Jeong-Sik Byeon, Doctor	Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center	Recruiting	Seoul	Seoul	138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003111	Colonic Polyps

Ancestor Terms

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

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