Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer

Fujian Medical University

Status

Completed

Conditions

Stomach Neoplasms

Treatments

Procedure: 2D Laparoscopic Surgery

Procedure: 3D Laparoscopic Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02327481

FUGES-001

Details and patient eligibility

About

The purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.

Full 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/5-year survival and recurrence rates.

Enrollment

438 patients

Sex

All

Ages

19 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

(1)Age from over 19 to under 74 years
(2)cT1-4a(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 the main abdominal 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 the past six months
(6)History of cerebrovascular accident within the 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