Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
- Conditions
- Stomach Neoplasms
- Interventions
- Procedure: D2 lymphadenectomy including No. 10Procedure: D2 lymphadenectomy excluding No. 10
- Registration Number
- NCT02333721
- Lead Sponsor
- Fujian Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 536
- Age from 18 to 75 years
- Primary proximal gastric adenocarcinoma not invading greater curvature (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of predicted values
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D2 Lymphadenectomy including No. 10 D2 lymphadenectomy including No. 10 Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group D2 lymphadenectomy excluding No. 10 D2 lymphadenectomy excluding No. 10 Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group
- Primary Outcome Measures
Name Time Method 3-year disease free survival rate 36 months
- Secondary Outcome Measures
Name Time Method Morbidity and mortality 30 days; 36 months 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.
3-year overall survival rate 36 months 3-year overall survival rate
3-year recurrence pattern 36 months Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Time to first ambulation 10 days The data of postoperative recovery course.
Rates of splenectomy 1 day splenectomy performing by severe injury to the splenic vessels
Rates of injury to splenic vessels 1 day intraoperative injury to the splenic vessels
The number of lymph node dissection 1 day The total number of lymph node dissection and the number of lymph node dissection in each station
The variation of weight 12 months The variation of weight on postoperative 3, 6, 9 and 12 months
The daily highest body temperature 7 days The daily highest body temperature before discharge
Time to first flatus 10 days The time to first flatus
Time to first liquid diet 10 days The time to first liquid diet
Time to soft diet 10 days The time to soft diet
Duration of hospital stay 10 days Duration of hospital stay
The amount of abdominal drainage 10 days The amount of abdominal drainage
Blood transfusion 10 days Perioperative blood transfusion
The number of positive lymph nodes 1 day The number of positive lymph nodes
Intraoperative lymph node dissection time 1 day 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)
Intraoperative blood loss 1 day Intraoperative blood loss
Intraoperative injury 1 day Intraoperative injury
The amount of use of titanium clip 1 day The amount of use of titanium clip
The rate of conversion to laparotomy 1 day The rate of conversion to laparotomy
The variation of cholesterol 12 months The variation of cholesterol on postoperative 3, 6, 9 and 12 months
The variation of albumin 12 months The variation of albumin on postoperative 3, 6, 9 and 12 months
The results of endoscopy 12 months the results of endoscopy on postoperative 3 and 12 months
The values of white blood cell count 7 days the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
The values of hemoglobin 7 days and the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
The values of C-reactive protein 7 days and the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
The values of prealbumin 7 days and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
The values of relevant immune cytokines 7 days 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.
The Surgery Task Load Index (SURG-TLX) 1 days Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Lymph node noncompliance rate 1 days 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.
Technical performance 1 days Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China