Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Procedure: D2 lymphadenectomy including No. 14v; Procedure: lymphadenectomy excluding No. 14v

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.

• Study Type: Interventional
• Enrollment (Anticipated): 326
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: D2 lymphadenectomy including No. 14v; 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
Active Comparator: D2 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	Procedure: lymphadenectomy excluding No. 14v; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
3-year disease overall survival rate	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss		1 day
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.	30 days; 36 months
Time to first ambulation	The data of postoperative recovery course.	10 days
The variation of weight	The variation of weight on postoperative 3, 6, 9 and 12 months	12 months
The daily highest body temperature	The daily highest body temperature before discharge	7 day
Time to first flatus		10 days
Time to first liquid diet		10 days
Time to soft diet		10 days
Duration of hospital stay		10 days
The amount of abdominal drainage		10 days
Blood transfusion		10 days
The number of positive lymph nodes		1 day
The rate of conversion to laparotomy		1 day
The variation of cholesterol	The variation of cholesterol on postoperative 3, 6, 9 and 12 months	12 months
The variation of albumin	The variation of albumin on postoperative 3, 6, 9 and 12 months	12 months
The results of endoscopy	the results of endoscopy on postoperative 3 and 12 months	12 months
Visual Analog Score for pain	the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded.	7 days
No.14v Lymph node metastasis rate		10 days
3-year free survival rate		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	36 months
The number of lymph node dissection		10day
Intraoperative lymph node dissection time	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	1 day
Intraoperative injury		1 day
The amount of use of titanium clip		1 day
The values of white blood cell count	the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded	7 days
The values of hemoglobin	and the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
The values of C-reactive protein	and the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
The values of prealbumin	and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
The values of relevant immune cytokines	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.	7 days
EORTC QLQ-C30 and QLQ - STO22	European Organization fo Research and Treatment(EORTC) QLQ-C30 and QLQ - STO22 before operation and on postoperative month 6,12,36 are recorded.	Time Frame: 36 months

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: May 29, 2016
• First Submitted That Met QC Criteria: May 29, 2016
• First Posted (Estimate): June 3, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2016-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No