Trials Comparing of HD Versus 4K Laparoscopy for Gastric Cancer
- Conditions
- Stomach Neoplasms
- Interventions
- Procedure: 4K Laparoscopic SurgeryProcedure: HD Laparoscopic Surgery
- Registration Number
- NCT04010006
- Lead Sponsor
- Fujian Medical University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 502
- (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
- (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4K Laparoscopic Surgery 4K Laparoscopic Surgery 4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group. HD Laparoscopic Surgery HD Laparoscopic Surgery HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
- Primary Outcome Measures
Name Time Method operating time 1 day day
- Secondary Outcome Measures
Name Time Method Time to first ambulation 10 days Time to first ambulation
intracavitary anastomosis time 1 day (patients who undergo totally laparoscopic surgery are analyzed)
the number of positive lymph nodes 1 day the number of positive lymph nodes
intraoperative lymph node dissection time 1 day (regional analysis:infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node,cardial area lymph node)
intraoperative blood loss 1 day ml
the amount of use of titanium clip 1 day the amount of use of titanium clip
duration of postoperative hospital stay 10 days duration of postoperative hospital stay
3-year overall survival rate 36 months month
Time to first flatus 10 days Time to first flatus
Complication 30 days;36 months (early complications occurred within 30 days after operation): pulmonary infection, incision complication, intestinal obstruction, abdominal infection, anastomotic bleeding, anastomotic fistula, gastric emptying; long term complications (30 days later after operation): anastomotic stenosis, intestinal obstruction, dumping syndrome
The number of lymph node dissection 1 day number
intraoperative injury 1 day intraoperative injury
Hospitalization expenses 1 months dolloars
the rate of conversion to laparotomy 1 day the rate of conversion to laparotomy
The daily highest body temperature before discharge 7 days The daily highest body temperature before discharge
Time to first liquid diet 10 days Time to first liquid diet
Time to first soft diet 10 days Time to first soft diet
Overall postoperative morbidity and mortality rates 30 days The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative and postoperative morbidity and mortality as the numerator are used to calculate the proportions.
Postoperative morbidities are divided into short-term and long-term complications after surgery.
Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is \> 30 days.
Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery \>30 days) and 3 years after the operation.
Postoperative mortality: patients whose death was identified according to documented intraoperative observation items, including patients who die within 30 days after surgery (including the 30th day) regardless of the causality between death and surgery, and patients who die more than 30 days after surgery.3-year disease free survival rate 36 months month
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China