Clinical trial NCT04010006: Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer
Official title: Randomized Controlled Trials Comparing Clinical Outcome of HD Versus 4K Laparoscopy for Gastric Cancer(FUGES-017)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Stomach Neoplasms
Laparoscopy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 502
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: operating time
timeFrame: 1 day
Secondary outcomes:
measure: The number of lymph node dissection
timeFrame: 1 day
measure: the number of positive lymph nodes
timeFrame: 1 day
measure: intraoperative lymph node dissection time
timeFrame: 1 day
measure: intracavitary anastomosis time
timeFrame: 1 day
measure: intraoperative blood loss
timeFrame: 1 day
measure: intraoperative injury
timeFrame: 1 day
measure: the amount of use of titanium clip
timeFrame: 1 day
measure: the rate of conversion to laparotomy
timeFrame: 1 day
measure: Time to first ambulation
timeFrame: 10 days
measure: Time to first flatus
timeFrame: 10 days
measure: Time to first liquid diet
timeFrame: 10 days
measure: Time to first soft diet
timeFrame: 10 days
measure: duration of postoperative hospital stay
timeFrame: 10 days
measure: Complication
timeFrame: 30 days;36 months
measure: The daily highest body temperature before discharge
timeFrame: 7 days
measure: Overall postoperative morbidity and mortality rates
timeFrame: 30 days
measure: Hospitalization expenses
timeFrame: 1 months
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year overall survival rate
timeFrame: 36 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Changming Huang Huang
role: STUDY_CHAIR
References: