Endoscopic Submucosal Dissection Combine With Laparoscopi... | NCT02325999

Studies
Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection for Early Gastric Cancer

NCT02325999

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

Dec 25, 2014Estimated

Enrollment

200Estimated

Phase

Early Phase 1

Conditions

Early Gastric Cancer

Interventions

ESD AND LRLD

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

ID	Type	Description	Link
BeijingFHMH2013	Other Grant/Funding Number	BeijingFH

Status Module

Record Verification Date

Dec 2014

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

Dec 2013

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Dec 31, 2013

First Submission Date that Met QC Criteria

Dec 21, 2014

First Posted Date

Dec 25, 2014Estimated

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

Dec 21, 2014

Last Update Posted Date

Dec 25, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hua Meng, Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer, Beijing Friendship HospitalPrincipal Investigator

Lead Sponsor

Beijing Friendship HospitalOTHER

Collaborators

Not provided

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

The purpose of this study is to determine whether Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer can improve Disease-free survival ？

Detailed Description

Patients with early stage of gastric cancer(T1a/T1bN0M0,NCCN2014.V1) will depart into two group randomized double-blind, then experimental group accept Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection ,and control group accept Endoscopic Submucosal Dissection only.The follow-up time is from operation to recrudescence.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESD and LRLD	Experimental	The experimental group accept Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection.	Procedure: ESD AND LRLD
Endoscopic Submucosal Dissection (ESD)	No Intervention	The group accept Endoscopic Submucosal Dissection only.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ESD AND LRLD	Procedure	A new therapy for gastric cancer : Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection.	ESD and LRLD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DFS	Follow-up Disease-free Survival	Five years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cT1a：ulcer（+）and lesion diameter>3cm and differentiated type. Any ulcer and lesion diameter d>2cm and poorly differentiated type.
cT1b: Submucosal injection (+)

Exclusion Criteria:

metastasis
recrudescence

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hua MENG	Contact	+8613488882358		Meng.doctor@gmail.com
Qiu-yue ZHANG	Contact	+8615810110118		zhangqiu3660@icloud.com

Overall Officials

Name	Affiliation	Role
Shu-tian ZHANG	Beijing Friendship Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The capital health research and development of special	Recruiting	Beijing	Beijing Municipality	100050	China

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
C020149	s-formylglutathione hydrolase

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided