The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
NCT ID: NCT02902575
Last Updated: 2021-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2016-09-01
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Laparoscopic-assisted Gastrectomy
Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Fujian Medical University
OTHER
Responsible Party
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Chang-Ming Huang, Prof.
Professor
Other Identifiers
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FUGES-05
Identifier Type: -
Identifier Source: org_study_id
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