A Phase 3 interventional study of Laparoscopic gastrectomy and Open gastrectomy in Stomach Neoplasms, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 14 sites in China. Open to participants aged 19 Years to 74 Years. Per ClinicalTrials.gov, last updated 2015-01-27.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 3, Interventional, and Treatment
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 1,056 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic gastrectomy
Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Open gastrectomy
* After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection 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.
Also known as: LDG
* After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent. * The type of reconstruction will be selected according to the surgeon's experience.
Also known as: ODG
3-year disease free survival rate
Time frame: 36 months
Morbidity and mortality
The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
Time frame: 30 days; 36 months
3-year overall survival rate
Time frame: 36 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.
Time frame: 36 months
Postoperative recovery course
* Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recovery course. * The amount of abdominal drainage and blood transfusion are also recorded.
Time frame: 10 days
Inflammatory and immune response
The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including IL-6, T cell count, T-helper lymphocytes (CD4+) count, T-suppressor lymphocytes (CD8+) count, natural killer (NK) cells count, B-lymphocytes count, and TNF-α from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time frame: 7 days
This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University