The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy

The purpose of this study is to explore the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Procedure: Laparoscopic-assisted gastrectomy with D2 lymphadenectomy

Detailed Description

A prospective single-arm study designed to further evaluate laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy will be performed, to evaluate the safety, feasibility, long-term and oncological outcomes. The evaluation parameters are perioperative mobility and mortality, perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age from 18 to 75 years
• Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
• cT2-4aN+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, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
• History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
• History of other malignant disease within past five years
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Laparoscopic-assisted Gastrectomy; Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group

Procedure: Laparoscopic-assisted gastrectomy with D2 lymphadenectomy; After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic-assisted gastrectomy with D2 lymphadenectomy 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	The early postoperative complication are defined as the event observed within 30 days after surgery.Postoperative complications were graded according to the Clavien-Dindo classification system	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The variation of weight	The variation of weight on postoperative 3, 6, 9 and 12 months	12 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 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
3-year disease free survival rate	3-year disease free survival rate	36 months
Time to first flatus	Time to first flatus	10 days
Time to first liquid diet	Time to first liquid diet	10 days
3-year overall survival rate	3-year overall survival rate	36 months
Rates of combined organ resection	Combined organ resection performing by severe injury or abdominal adhesions	1 day
The daily highest body temperature	The daily highest body temperature before discharge	7 days
The values of hemoglobin	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	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	the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
Late postoperative complication	The late postoperative complication was defined as the event observed within the period from postoperative day 31th to the end of month 36th.	36 months
Duration of hospital stay	Duration of hospital stay	10 days
Pathological response	Pathological response grading was performed according to the Becker TRG system	30 days
Radiological response	Radiological response and progression were assessed according to RECIST version 1.1	30 days
Mortality	The early mortality are defined as the event observed within 30 days after surgery.	30 days
Time to first ambulation	The data of postoperative recovery course	10 days
The number of lymph node dissection	The number of lymph node dissection	1 day
Time to soft diet	Time to soft diet	10 days
Scale the amount of abdominal drainage	Scale the amount of abdominal drainage	10 days
Blood transfusion	Blood transfusion	10 days
The number of positive lymph nodes	The number of positive lymph nodes	1 days
Intraoperative lymph node dissection time	intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node and jejunal lymph nodes adjacent to the anastomosis.	1 days
Intraoperative blood loss	Intraoperative blood loss	1 days
Time of operation	Time of operation	1 day
Intraoperative injury	Intraoperative injury	1 days
The amount of use of titanium clip	The amount of use of titanium clip	1 days
The rate of conversion to laparotomy	The rate of conversion to laparotomy	1 days
The variation of albumin	The variation of albumin on postoperative 3, 6, 9 and 12 months	12 month
The results of endoscopy	the results of endoscopy on postoperative 3 and 12 months	12 month
Adverse events	Adverse events (AEs) of neoadjuvant chemotherapy were assessed at each visit per the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)	30 days

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: September 11, 2016
• First Submitted That Met QC Criteria: September 11, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Laparoscopy; Stomach Neoplasms; Neoadjuvant Chemotherapy; Advanced Gastric Cancer
• 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: FUGES-05