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NCT02325999 Clinical Trial

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

Early Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02325999
Other study ID # ESDLD2013
Secondary ID BeijingFHMH2013
Status Recruiting
Phase Phase 0
First received December 31, 2013
Last updated December 21, 2014
Start date December 2013
Est. completion date December 2019

Study information
Verified date December 2014
Source Beijing Friendship Hospital
Contact Hua MENG
Phone +8613488882358
Email Meng.doctor@gmail.com
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical Trial 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 ？

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• ESD AND LRLD
A new therapy for gastric cancer : Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection.

Locations
Country Name City State
China The capital health research and development of special Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary DFS Follow-up Disease-free Survival Five years Yes
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