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Prospective Randomized Trial of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer

18 Years
80 Years
Open (Enrolling)
Stomach Neoplasm, Laparoscopy, Gastrectomy, Complications

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Trial Information

Prospective Randomized Trial of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer

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.

Inclusion Criteria:

1. Pathologically proven gastric adenocarcinoma

2. Age:older than 18 years old,younger than 80 years old

3. Preoperative stage(CT, GFS stage):cT2N0M0, cT2N1M0, cT2N2M0, cT3N0M0,

4. ASA score:≤3

5. Patients with an invasion of the gastric serosa exceeding 10 cm2 according to
ultrasound examination or examination during surgery were excluded

6. No history of other cancer

7. No history of chemotherapy or radiotherapy

8. Written informed consent

Exclusion Criteria:

1. Concurrent cancer patients or patient who was treated due to other types of cancer
before the patient was diagnosed as a gastric cancer patient

2. Patient who was treated by other types of treatment methods, such as chemotherapy,
immunotherapy, or radiotherapy

3. Patient who was received upper abdominal surgery (except, laparoscopic

4. ASA score:>3

5. Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias,
diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy

6. Complicated case needed to get emergency operation

7. Any accompanying surgical condition needed to be performed in same time

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

3 years

Safety Issue:



China: Ministry of Health

Study ID:




Start Date:

February 2010

Completion Date:

February 2015

Related Keywords:

  • Stomach Neoplasm
  • Laparoscopy
  • Gastrectomy
  • Complications
  • Stomach Neoplasm
  • Laparoscopy
  • gastrectomy
  • Neoplasms
  • Stomach Neoplasms