Clinical trial NCT02789891: Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection
Official title: Randomized Controlled Trials on Laparoscopic No. 14v Lymph Node Dissection for Advanced Lower Third Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 326
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
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 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.

Eligibility criteria: Inclusion Criteria:• 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

Exclusion Criteria:• 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

Primary outcomes:
measure: 3-year disease overall survival rate
timeFrame: 36 months
Secondary outcomes:
measure: No.14v Lymph node metastasis rate
timeFrame: 10 days
measure: Morbidity and mortality
timeFrame: 30 days; 36 months
measure: 3-year free survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Time to first ambulation
timeFrame: 10 days
measure: The number of lymph node dissection
timeFrame: 10day
measure: The variation of weight
timeFrame: 12 months
measure: The daily highest body temperature
timeFrame: 7 day
measure: Time to first flatus
timeFrame: 10 days
measure: Time to first liquid diet
timeFrame: 10 days
measure: Time to soft diet
timeFrame: 10 days
measure: Duration of hospital stay
timeFrame: 10 days
measure: The amount of abdominal drainage
timeFrame: 10 days
measure: Blood transfusion
timeFrame: 10 days
measure: The number of positive lymph nodes
timeFrame: 1 day
measure: Intraoperative lymph node dissection 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: The variation of cholesterol
timeFrame: 12 months
measure: The variation of albumin
timeFrame: 12 months
measure: The results of endoscopy
timeFrame: 12 months
measure: The values of white blood cell count
timeFrame: 7 days
measure: The values of hemoglobin
timeFrame: 7 days
measure: The values of C-reactive protein
timeFrame: 7 days
measure: The values of prealbumin
timeFrame: 7 days
measure: The values of relevant immune cytokines
timeFrame: 7 days
measure: Visual Analog Score for pain
timeFrame: 7 days
measure: EORTC QLQ-C30 and QLQ - STO22
timeFrame: Time Frame: 36 months
Other outcomes:
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