Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection
- Conditions
- Stomach Neoplasms
- Interventions
- Procedure: D2 lymphadenectomy including No. 14vProcedure: lymphadenectomy excluding No. 14v
- Registration Number
- NCT02789891
- 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 No. 14v lymph node dissection in advanced lower third gastric cancer.
- Detailed Description
A prospective randomized comparison of laparoscopic No. 14v lymph node dissection in advanced lower third 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
- 326
• Age from 18 to 75 years
- Primary lower third gastric adenocarcinoma (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 envelop important vessels
- 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. 14v D2 lymphadenectomy including No. 14v Laparoscopic distal gastrectomy with D2 lymphadenectomy including No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group D2 lymphadenectomy excluding No. 14v lymphadenectomy excluding No. 14v Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group
- Primary Outcome Measures
Name Time Method 3-year disease overall survival rate 36 months
- Secondary Outcome Measures
Name Time Method No.14v Lymph node metastasis rate 10 days The results of endoscopy 12 months the results of endoscopy on postoperative 3 and 12 months
Time to soft diet 10 days The variation of cholesterol 12 months The variation of cholesterol on postoperative 3, 6, 9 and 12 months
3-year free survival rate 36 months The variation of weight 12 months The variation of weight on postoperative 3, 6, 9 and 12 months
Time to first liquid diet 10 days 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 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
Duration of hospital stay 10 days The variation of albumin 12 months The variation of albumin on postoperative 3, 6, 9 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.
Time to first ambulation 10 days The data of postoperative recovery course.
The number of lymph node dissection 10day The daily highest body temperature 7 day The daily highest body temperature before discharge
Time to first flatus 10 days The amount of abdominal drainage 10 days Intraoperative lymph node dissection time 1 day intraoperative No.14v lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node
The amount of use of titanium clip 1 day The rate of conversion to laparotomy 1 day Visual Analog Score for pain 7 days the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded.
EORTC QLQ-C30 and QLQ - STO22 Time Frame: 36 months European Organization fo Research and Treatment(EORTC) QLQ-C30 and QLQ - STO22 before operation and on postoperative month 6,12,36 are recorded.
Blood transfusion 10 days The number of positive lymph nodes 1 day Intraoperative blood loss 1 day Intraoperative injury 1 day 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 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 values of prealbumin 7 days and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.