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

Not Applicable

Completed

• Conditions: Stomach Neoplasms
• Interventions: Procedure: Laparoscopic-assisted gastrectomy with D2 lymphadenectomy

• Registration Number: NCT02902575
• Lead Sponsor: Fujian Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-11
• Study First Submitted QC: 2016-09-11
• Study First Posted: 2016-09-16
• Primary Completion: 2019-10-31
• Study Completion: 2019-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic-assisted Gastrectomy	Laparoscopic-assisted gastrectomy with D2 lymphadenectomy	Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group

Primary Outcome Measures

Name	Time	Method
Morbidity	30 days	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

Secondary Outcome Measures

Name	Time	Method
3-year disease free survival rate	36 months	3-year disease free survival rate
The values of C-reactive protein	7 days	the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Pathological response	30 days	Pathological response grading was performed according to the Becker TRG system
The number of lymph node dissection	1 day	The number of lymph node dissection
Time to first flatus	10 days	Time to first flatus
Blood transfusion	10 days	Blood transfusion
Duration of hospital stay	10 days	Duration of hospital stay
3-year overall survival rate	36 months	3-year overall survival rate
Time to first liquid diet	10 days	Time to first liquid diet
Time of operation	1 day	Time of operation
Intraoperative injury	1 days	Intraoperative injury
Mortality	30 days	The early mortality are defined as the event observed within 30 days after surgery.
Time to first ambulation	10 days	The data of postoperative recovery course
Rates of combined organ resection	1 day	Combined organ resection performing by severe injury or abdominal adhesions
Time to soft diet	10 days	Time to soft diet
The number of positive lymph nodes	1 days	The number of positive lymph nodes
The amount of use of titanium clip	1 days	The amount of use of titanium clip
The values of white blood cell count	7 days	the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded
Radiological response	30 days	Radiological response and progression were assessed according to RECIST version 1.1
Scale the amount of abdominal drainage	10 days	Scale the amount of abdominal drainage
The results of endoscopy	12 month	the results of endoscopy on postoperative 3 and 12 months
The values of hemoglobin	7 days	the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Adverse events	30 days	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)
3-year recurrence pattern	36 months	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
The variation of weight	12 months	The variation of weight on postoperative 3, 6, 9 and 12 months
The daily highest body temperature	7 days	The daily highest body temperature before discharge
Intraoperative lymph node dissection time	1 days	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.
Intraoperative blood loss	1 days	Intraoperative blood loss
The rate of conversion to laparotomy	1 days	The rate of conversion to laparotomy
The variation of albumin	12 month	The variation of albumin on postoperative 3, 6, 9 and 12 months
The values of prealbumin	7 days	the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Late postoperative complication	36 months	The late postoperative complication was defined as the event observed within the period from postoperative day 31th to the end of month 36th.