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

Primary Purpose

Early Gastric Cancer

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
ESD AND LRLD
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Gastric Cancer focused on measuring Endoscopic Submucosal Dissection, Laparoscopic Regional Lymph node Dissection, early gastric cancer, Disease-free survival

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The capital health research and development of specialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ESD and LRLD

Endoscopic Submucosal Dissection (ESD)

Arm Description

The experimental group accept Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection.

The group accept Endoscopic Submucosal Dissection only.

Outcomes

Primary Outcome Measures

DFS
Follow-up Disease-free Survival

Secondary Outcome Measures

Full Information

First Posted
December 31, 2013
Last Updated
December 21, 2014
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02325999
Brief Title
Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection for Early Gastric Cancer
Official Title
Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection:a New Therapy for Early Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer
Keywords
Endoscopic Submucosal Dissection, Laparoscopic Regional Lymph node Dissection, early gastric cancer, Disease-free survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESD and LRLD
Arm Type
Experimental
Arm Description
The experimental group accept Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection.
Arm Title
Endoscopic Submucosal Dissection (ESD)
Arm Type
No Intervention
Arm Description
The group accept Endoscopic Submucosal Dissection only.
Intervention Type
Procedure
Intervention Name(s)
ESD AND LRLD
Intervention Description
A new therapy for gastric cancer : Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection.
Primary Outcome Measure Information:
Title
DFS
Description
Follow-up Disease-free Survival
Time Frame
Five years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua MENG
Phone
+8613488882358
Email
Meng.doctor@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiu-yue ZHANG
Phone
+8615810110118
Email
zhangqiu3660@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-tian ZHANG
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The capital health research and development of special
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua MENG
Phone
+8613488882358
First Name & Middle Initial & Last Name & Degree
Qiu-yue ZHANG
Phone
+8615810110118

12. IPD Sharing Statement

Learn more about this trial

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

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