Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer

Fujian Medical University

Status

Unknown

Conditions

Stomach Neoplasms

Treatments

Procedure: 4K Laparoscopic Surgery

Procedure: HD Laparoscopic Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04010006

FUGES-017

Details and patient eligibility

About

The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.

Full description

A prospective randomized comparison of HD and 4K 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 4K laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Enrollment

502 estimated 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)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