An interventional study of Laparoscopic gastrectomy and Open gastrectomy in Stomach Neoplasms, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 19 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric cancer is popular in East Asian countries. However, the long-term follow-up outcome based on randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is still limited because of lack of solid evidence on the oncologic efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 percent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer based on a well designed RCT is needed.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 178 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 130 studies on the registry; 34 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
3-year disease free survival rate
Time frame: 36 months
Morbidity
Time frame: 30 days
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Mortality
Time frame: 30 days
Morbidity
Time frame: 36 months
Mortality
Time frame: 36 months
Postoperative recovery situation
Time to first ambulation, flatus, liquid diet, soft diet and duration of hospital stay are used to assess the postoperative recovery situation.
Time frame: 10 days
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Third Affiliated Hospital, Sun Yat-Sen University