Overview

This trial is active, not recruiting.

Condition stomach neoplasms
Treatments d2 lymphadenectomy including no. 10, d2 lymphadenectomy excluding no. 10
Phase phase 3
Sponsor Fujian Medical University
Start date January 2015
End date December 2017
Trial size 536 participants
Trial identifier NCT02333721, 2015-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 including no. 10
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
(Active Comparator)
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
d2 lymphadenectomy excluding no. 10
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy

Primary Outcomes

Measure
3-year disease free survival rate
time frame: 36 months

Secondary Outcomes

Measure
Morbidity and mortality
time frame: 30 days; 36 months
3-year overall survival rate
time frame: 36 months
3-year recurrence pattern
time frame: 36 months
Time to first ambulation
time frame: 10 days
Rates of splenectomy
time frame: 1 day
Rates of injury to splenic vessels
time frame: 1 day
The number of lymph node dissection
time frame: 1 day
The variation of weight
time frame: 12 months
The daily highest body temperature
time frame: 7 days
Time to first flatus
time frame: 10 days
Time to first liquid diet
time frame: 10 days
Time to soft diet
time frame: 10 days
Duration of hospital stay
time frame: 10 days
The amount of abdominal drainage
time frame: 10 days
Blood transfusion
time frame: 10 days
The number of positive lymph nodes
time frame: 1 day
Intraoperative lymph node dissection time
time frame: 1 day
Intraoperative blood loss
time frame: 1 day
Intraoperative injury
time frame: 1 day
The amount of use of titanium clip
time frame: 1 day
The rate of conversion to laparotomy
time frame: 1 day
The variation of cholesterol
time frame: 12 months
The variation of albumin
time frame: 12 months
The results of endoscopy
time frame: 12 months
The values of white blood cell count
time frame: 7 days
The values of hemoglobin
time frame: 7 days
The values of C-reactive protein
time frame: 7 days
The values of prealbumin
time frame: 7 days
The values of relevant immune cytokines
time frame: 7 days

Eligibility Criteria

Male or female participants from 10 years up to 75 years old.

Inclusion Criteria: - Age from 18 to 75 years - Primary distal 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 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

Additional Information

Official title Study on Long-term Outcome of Laparoscopic Spleen-Preserving D2 Lymphadenectomy With and Without No. 10 Lymph Node Dissection for Advanced Gastric Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Fujian Medical University.