Overview

This trial is active, not recruiting.

Condition stomach neoplasms
Treatments 3d laparoscopic surgery, 2d laparoscopic surgery
Phase phase 3
Sponsor Fujian Medical University
Start date January 2015
End date June 2016
Trial size 438 participants
Trial identifier NCT02327481, 2015-02

Summary

The purpose of this study is to explore the feasibility of 3D Laparoscopic Surgery for Gastric Cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
3D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
3d laparoscopic surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,3D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
(Active Comparator)
2D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
2d laparoscopic surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,2D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.

Primary Outcomes

Measure
operating time
time frame: 1 day

Secondary Outcomes

Measure
Intraoperative situation
time frame: 1 day
Postoperative recovery course
time frame: 10 days
Complication
time frame: 30 days;36 months
The postoperative pathology
time frame: 7 days
Inflammatory and immune response
time frame: 7 days
Morbidity and mortality
time frame: 30 days;36 months
Hospitalization expenses
time frame: 1 months
3-year disease free survival rate
time frame: 36 months
3-year overall survival rate
time frame: 36 months

Eligibility Criteria

Male or female participants from 19 years up to 74 years old.

Inclusion Criteria: - (1)Age from over 19 to under 74 years - (2)cT 1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition - (3)Heart, lungs, kidneys and other vital organs function well, with no obvious surgical contraindications - (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs - (5)American Society of Anesthesiology (ASA) score class I, II, or III - (6)Written informed consent Exclusion Criteria: - (1)Women during pregnancy or breast-feeding - (2)Severe mental disorder - (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy) - (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels - (5)History of unstable angina or myocardial infarction within past six months - (6)History of cerebrovascular accident within past six months - (7)History of continuous systematic administration of corticosteroids within one month - (8)History of previous neoadjuvant chemotherapy or radiotherapy - (9)T4b tumors - (10)Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer - (11)FEV1(Forced expiratory volume in one second)<50% of predicted values

Additional Information

Official title Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
Description A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Fujian Medical University.