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

NCT ID: NCT02325999

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Early Gastric Cancer

Keywords

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Endoscopic Submucosal Dissection Laparoscopic Regional Lymph node Dissection early gastric cancer Disease-free survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ESD and LRLD

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

Group Type EXPERIMENTAL

ESD AND LRLD

Intervention Type PROCEDURE

A new therapy for gastric cancer : Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection.

Endoscopic Submucosal Dissection (ESD)

The group accept Endoscopic Submucosal Dissection only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ESD AND LRLD

A new therapy for gastric cancer : Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hua Meng

Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shu-tian ZHANG

Role: STUDY_CHAIR

Beijing Friendship Hospital

Locations

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The capital health research and development of special

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua MENG

Role: CONTACT

Phone: +8613488882358

Email: [email protected]

Qiu-yue ZHANG

Role: CONTACT

Phone: +8615810110118

Email: [email protected]

Facility Contacts

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Hua MENG

Role: primary

Qiu-yue ZHANG

Role: backup

Other Identifiers

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BeijingFHMH2013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ESDLD2013

Identifier Type: -

Identifier Source: org_study_id