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

Fujian Medical University

Status

Completed

Conditions

Stomach Neoplasms

Treatments

Procedure: Laparoscopic-assisted gastrectomy with D2 lymphadenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02902575

FUGES-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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