NCT02302794

Brief Summary

evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).

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
1,056

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2014

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

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 27, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

November 25, 2014

Last Update Submit

November 25, 2014

Conditions

Locally Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival rate

    three years

Study Arms (2)

open surgery

ACTIVE COMPARATOR

Conventional procedure

Procedure: open surgery

laparoscopic surgery

EXPERIMENTAL

Minimum invasive procedure

Procedure: laparoscopic surgery

Interventions

open surgeryPROCEDURE

Patients in this arm undergo radical resection of gastric cancer in open surgery.Open surgery is a conventional technique for gastric cancer patients.

Also known as: group A, open
open surgery
laparoscopic surgeryPROCEDURE

Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for gastric cancer patients.

Also known as: group B, laparoscopic
laparoscopic surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years \~ 75 years;
  • the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);
  • clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);
  • to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply)
  • ECOG performance status 0/1;
  • ASA score I-III;
  • patient informed consent.

You may not qualify if:

  • pregnant or lactating women;
  • serious mental illness;
  • upper abdominal surgery (except laparoscopic cholecystectomy );
  • gastric surgery (including for gastric ESD / EMR);
  • imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
  • other malignant diseases in 5 years;
  • implemented or recommended neoadjuvant therapy in patients with gastric cancer ;
  • have unstable angina or myocardial infarction within six months; (9) have cerebral infarction or cerebral hemorrhage within 6 months; (10) sustained systemic glucocorticoid treatment history within 1 month; (11) have other diseases needed operative treatment at the same time; (12) complications (bleeding, perforation, obstruction) required emergency surgery; (13) Pulmonary function tests FEV1 \<50% of predicted value.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Interventions

Conversion to Open SurgeryLaparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Guobin Wang, MD,PhD

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY CHAIR

  • Kaixiong Tao, MD,PhD

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY DIRECTOR

Central Study Contacts

Guobin Wang, MD,PhD

CONTACT

+86 027 85726139wangguobin1954@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician of gastrointestinal surgery

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 27, 2014

Record last verified: 2014-07

Locations

CN(1)