NCT02325999

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 ？

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2013

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2013

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 25, 2014

Status Verified

December 1, 2014

Enrollment Period

5 years

First QC Date

December 31, 2013

Last Update Submit

December 21, 2014

Conditions

Early Gastric Cancer

Keywords

Endoscopic Submucosal DissectionLaparoscopic Regional Lymph node Dissectionearly gastric cancerDisease-free survival

Outcome Measures

Primary Outcomes (1)

  • DFS

    Follow-up Disease-free Survival

    Five years

Study Arms (2)

ESD and LRLD

EXPERIMENTAL

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

Procedure: ESD AND LRLD

Endoscopic Submucosal Dissection (ESD)

NO INTERVENTION

The group accept Endoscopic Submucosal Dissection only.

Interventions

ESD AND LRLDPROCEDURE

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

ESD and LRLD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cT1a：ulcer（+）and lesion diameter\>3cm and differentiated type. Any ulcer and lesion diameter d\>2cm and poorly differentiated type.
  • cT1b: Submucosal injection (+)

You may not qualify if:

  • metastasis
  • recrudescence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The capital health research and development of special

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

s-formylglutathione hydrolase

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Shu-tian ZHANG

    Beijing Friendship Hospital

    STUDY CHAIR

Central Study Contacts

Hua MENG

CONTACT

+8613488882358Meng.doctor@gmail.com

Qiu-yue ZHANG

CONTACT

+8615810110118zhangqiu3660@icloud.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer

Study Record Dates

First Submitted

December 31, 2013

First Posted

December 25, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

December 25, 2014

Record last verified: 2014-12

Locations

CN(1)