NCT Number: NCT02902575
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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
Time frame: 30 days
Pathological response grading was performed according to the Becker TRG system
Time frame: 30 days
Radiological response and progression were assessed according to RECIST version 1.1
Time frame: 36 months
3-year disease free survival rate
Time frame: 36 months
3-year overall survival rate
Time frame: 36 months
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Time frame: 30 days
The early mortality are defined as the event observed within 30 days after surgery.
Time frame: 10 days
The data of postoperative recovery course
Time frame: 1 day
Combined organ resection performing by severe injury or abdominal adhesions
Time frame: 1 day
The number of lymph node dissection
Time frame: 12 months
The variation of weight on postoperative 3, 6, 9 and 12 months
Time frame: 7 days
The daily highest body temperature before discharge
Time frame: 10 days
Time to first flatus
Time frame: 10 days
Time to first liquid diet
Time frame: 10 days
Time to soft diet
Time frame: 10 days
Scale the amount of abdominal drainage
Time frame: 10 days
Blood transfusion
Time frame: 1 days
The number of positive lymph nodes
Time frame: 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.
Time frame: 1 days
Intraoperative blood loss
Time frame: 1 day
Time of operation
Time frame: 1 days
Intraoperative injury
Time frame: 1 days
The amount of use of titanium clip
Time frame: 1 days
The rate of conversion to laparotomy
Time frame: 12 month
The variation of albumin on postoperative 3, 6, 9 and 12 months
Time frame: 12 month
the results of endoscopy on postoperative 3 and 12 months
Time frame: 7 days
the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded
Time frame: 7 days
the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 7 days
the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 7 days
the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 10 days
Duration of hospital stay
Time frame: 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.
Time frame: 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)
Fujian Medical University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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