Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection

Fujian Medical University326 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

326

Conditions

Stomach Neoplasms

Interventions

D2 lymphadenectomy including No. 14vPROCEDURE

After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal with D2 lymphadenectomy including No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience

lymphadenectomy excluding No. 14vPROCEDURE

After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience

Eligibility

Sex: ALLMin age: 10 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

3-year disease overall survival rate

Time frame: 36 months

Secondary Outcomes

No.14v Lymph node metastasis rate

Time frame: 10 days

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 free 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

The number of lymph node dissection

Time frame: 10day

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 day

Data from ClinicalTrials.gov

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