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Clinical Trials/NCT02789891
NCT02789891
Unknown
Not Applicable

Randomized Controlled Trials on Laparoscopic No. 14v Lymph Node Dissection for Advanced Lower Third Gastric Cancer

Fujian Medical University0 sites326 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stomach Neoplasms
Sponsor
Fujian Medical University
Enrollment
326
Primary Endpoint
3-year disease overall survival rate
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
January 2024
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fujian Medical University
Responsible Party
Principal Investigator
Principal Investigator

Chang-Ming Huang, Prof.

Director, Principal Investigator, Clinical Professor

Fujian Medical University

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

Outcomes

Primary Outcomes

3-year disease overall survival rate

Time Frame: 36 months

Secondary Outcomes

  • No.14v Lymph node metastasis rate(10 days)
  • Time to soft diet(10 days)
  • 3-year free survival rate(36 months)
  • The variation of weight(12 months)
  • Time to first liquid diet(10 days)
  • Morbidity and mortality(30 days; 36 months)
  • 3-year recurrence pattern(36 months)
  • Duration of hospital stay(10 days)
  • The variation of albumin(12 months)
  • The values of white blood cell count(7 days)
  • The values of hemoglobin(7 days)
  • Time to first ambulation(10 days)
  • The number of lymph node dissection(10day)
  • The daily highest body temperature(7 day)
  • Time to first flatus(10 days)
  • The amount of abdominal drainage(10 days)
  • Intraoperative lymph node dissection time(1 day)
  • The amount of use of titanium clip(1 day)
  • The rate of conversion to laparotomy(1 day)
  • The variation of cholesterol(12 months)
  • The results of endoscopy(12 months)
  • Visual Analog Score for pain(7 days)
  • EORTC QLQ-C30 and QLQ - STO22(Time Frame: 36 months)
  • 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)
  • The values of relevant immune cytokines(7 days)
  • The values of prealbumin(7 days)

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