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

Capital Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Early Gastric Cancer

Treatments: Procedure: ESD AND LRLD

Study type: Interventional

Funder types: Other

Identifiers

NCT02325999

ESDLD2013

BeijingFHMH2013 (Other Grant/Funding Number)

Details and patient eligibility

About

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 ？

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

ESD and LRLD

Experimental group

Description:

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

Treatment:

Procedure: ESD AND LRLD

Endoscopic Submucosal Dissection (ESD)

No Intervention group

Description:

The group accept Endoscopic Submucosal Dissection only.