A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery

November 25, 2014 updated by: Cai Kailin

Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Long-term Outcomes Between Laparoscopy-assisted and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study type：Interventional Study phase：Phase III Objectives of Study：to 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).

Study Type

Interventional

Enrollment (Anticipated)

1056

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Xinghua Liu, MD
        • Sub-Investigator:
          • Shi Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years ~ 75 years;
  2. the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);
  3. clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);
  4. to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply)
  5. ECOG performance status 0/1;
  6. ASA score I-III;
  7. patient informed consent.

Exclusion Criteria:

  1. pregnant or lactating women;
  2. serious mental illness;
  3. upper abdominal surgery (except laparoscopic cholecystectomy );
  4. gastric surgery (including for gastric ESD / EMR);
  5. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
  6. other malignant diseases in 5 years;
  7. implemented or recommended neoadjuvant therapy in patients with gastric cancer ;
  8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: open surgery
Conventional procedure
Procedure: open surgery
Patients in this arm undergo radical resection of gastric cancer in open surgery.Open surgery is a conventional technique for gastric cancer patients.
Other Names:
  • group A
  • open
Experimental: laparoscopic surgery
Minimum invasive procedure
Procedure: laparoscopic surgery
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.
Other Names:
  • group B
  • laparoscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-year disease free survival rate
Time Frame: three years
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cai Kailin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Estimate)

November 27, 2014

Last Update Submitted That Met QC Criteria

November 25, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChiCTR-TRC-14004877

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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