Surgicel® Fibrillar for Delayed Bleeding After ESD | NCT01758965

Studies
Surgicel® Fibrillar for Delayed Bleeding After ESD

NCT01758965

Sponsor

Soonchunhyang University Hospital

Status

Completed

Last Update Posted

May 13, 2014Estimated

Enrollment

146Actual

Phase

Not Applicable

Conditions

Benign Neoplasm of Stomach
Malignant Neoplasm of Stomach

Interventions

PPI
H2RA and surgicel

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

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Dec 27, 2012

First Submission Date that Met QC Criteria

Dec 27, 2012

First Posted Date

Jan 1, 2013Estimated

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 12, 2014

Last Update Posted Date

May 13, 2014Estimated

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 aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors

Detailed Description

Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer
- Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
- Anti-platelet agents
Method

(1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group: monotherapy with PPI 3. Sample size : 157 4. Result

Primary endpoint: rate of delayed bleeding after ESD
Secondary endpoint: follow-up hemoglobin after ESD

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

146Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
combination therapy of H2RA and surgicel	Experimental	H2RA and surgicel	Other: H2RA and surgicel
Monotherapy of PPI	Experimental	PPI	Other: PPI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PPI	Other	monotherapy of PPI	Monotherapy of PPI
H2RA and surgicel

Measure	Description	Time Frame
Delayed bleeding rate after ESD		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ESD for gastric dysplasia or early gastric cancer

Exclusion Criteria:

Coagulopathy: liver cirrhosis, thrombocytopenia
Anti-platelet agents

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine		Bucheon-si	Gyeonggi-do	420-767	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C013695	Surgicel

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided