Clinical trial NCT01043835: Comparison of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer:A Prospective Randomized Trial
Official title: Prospective Randomized Trial of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasm
Laparoscopy
Gastrectomy
Complications
Keywords: Stomach Neoplasm
Laparoscopy
gastrectomy
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.

Detailed description: 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.

Eligibility criteria: 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, cT3N1M0,cT3N2M0
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 cholecystectomy)
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

Primary outcomes:
measure: Disease free survival
timeFrame: 3 years
Secondary outcomes:
measure: Complications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22
timeFrame: 3 years
Other outcomes:
Locations:
city: Chong Qing
country: China
facility: Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital
state: Chong Qing
city: Chong Qing
country: China
facility: Southwest Hospital, China
state: Chong Qing
Study officials:
References: