Laparoscopy Clinical Trial
Official title:
Prospective Randomized Trial of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer
The purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.
Background: The use of laparoscopic surgery in the management of advanced gastric cancer
(AGC) has not yet met with widespread acceptance and remains limited to only a few centers.
Intervention: According to tumor pathological stage (JGCA, 2nd English ed), location of
tumor, and patient clinical condition, a laparoscopy-assisted radical gastrectomy and open
gastrectomy were performed. Laparoscopy-assisted radical gastrectomy consisted of the
following procedures: 1) laparoscopic dissection of the lesser and greater omentum, ligation
and division of the main vessels to mobilize the stomach under pneumoperitoneum, 2)
laparoscopic D2 lymph node dissection, based on the Guidelines of the Japan Gastric Cancer
Association and 3) resection of the distal two thirds (LADG), proximal third (LAPG), or
total stomach (LATG), depending on the location of the tumor, followed by reconstruction by
the Billroth I, Billroth Ⅱ, esophagogastrostomy, or Roux-en-Y method through a 3 to
5-cm-long minilaparotomy incision.
Follow-up schedule: All patients were monitored postoperatively by physical examination, and
blood tests including a test for serum carcinoembryonic antigen (CEA) at least every three
months for the first year, every six months for the next two years, and every year for the
fourth and fifth year, and thereafter by abdominal ultrasonography, CT, chest radiography,
and gastroscopy at least once each year.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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