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

December 21, 2014 updated by: Hua Meng, Beijing Friendship Hospital

Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection:a New Therapy for Early Gastric Cancer

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 ？

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • The capital health research and development of special
        • Contact:
          • Hua MENG
          • Phone Number: +8613488882358
        • Contact:
          • Qiu-yue ZHANG
          • Phone Number: +8615810110118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESD and LRLD
The experimental group accept Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection.
Procedure: ESD AND LRLD
A new therapy for gastric cancer : Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection.
No Intervention: Endoscopic Submucosal Dissection (ESD)
The group accept Endoscopic Submucosal Dissection only.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Chair: Shu-tian ZHANG, Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 31, 2013

First Submitted That Met QC Criteria

December 21, 2014

First Posted (Estimate)

December 25, 2014

Study Record Updates

Last Update Posted (Estimate)

December 25, 2014

Last Update Submitted That Met QC Criteria

December 21, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESDLD2013
  • BeijingFHMH2013 (Other Grant/Funding Number: BeijingFH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Gastric Cancer

Clinical Trials on ESD AND LRLD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe