The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature.
A prospective randomized comparison of laparoscopic spleen-preserving No. 10 lymph node dissection for gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
536
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITING3-year disease free survival rate
Time frame: 36 months
Morbidity and mortality
The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
Time frame: 30 days; 36 months
3-year overall survival rate
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Time frame: 36 months
Time to first ambulation
The data of postoperative recovery course.
Time frame: 10 days
Rates of splenectomy
splenectomy performing by severe injury to the splenic vessels
Time frame: 1 day
Rates of injury to splenic vessels
intraoperative injury to the splenic vessels
Time frame: 1 day
The number of lymph node dissection
The total number of lymph node dissection and the number of lymph node dissection in each station
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months
Time frame: 12 months
The daily highest body temperature
The daily highest body temperature before discharge
Time frame: 7 days
Time to first flatus
The time to first flatus
Time frame: 10 days
Time to first liquid diet
The time to first liquid diet
Time frame: 10 days
Time to soft diet
The time to soft diet
Time frame: 10 days
Duration of hospital stay
Duration of hospital stay
Time frame: 10 days
The amount of abdominal drainage
The amount of abdominal drainage
Time frame: 10 days
Blood transfusion
Perioperative blood transfusion
Time frame: 10 days
The number of positive lymph nodes
The number of positive lymph nodes
Time frame: 1 day
Intraoperative lymph node dissection time
intraoperative No.10 lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node)
Time frame: 1 day
Intraoperative blood loss
Intraoperative blood loss
Time frame: 1 day
Intraoperative injury
Intraoperative injury
Time frame: 1 day
The amount of use of titanium clip
The amount of use of titanium clip
Time frame: 1 day
The rate of conversion to laparotomy
The rate of conversion to laparotomy
Time frame: 1 day
The variation of cholesterol
The variation of cholesterol on postoperative 3, 6, 9 and 12 months
Time frame: 12 months
The variation of albumin
The variation of albumin on postoperative 3, 6, 9 and 12 months
Time frame: 12 months
The results of endoscopy
the results of endoscopy on postoperative 3 and 12 months
Time frame: 12 months
The values of white blood cell count
the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 7 days
The values of hemoglobin
and the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 7 days
The values of C-reactive protein
and the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 7 days
The values of prealbumin
and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 7 days
The values of relevant immune cytokines
and the values of relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 7 days
The Surgery Task Load Index (SURG-TLX)
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Time frame: 1 days
Lymph node noncompliance rate
Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.
Time frame: 1 days
Technical performance
Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.
Time frame: 1 days