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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yan Shi, Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01043835
First received: January 6, 2010
Last updated: June 4, 2012
Last verified: June 2012

January 6, 2010
June 4, 2012
February 2010
February 2015   (final data collection date for primary outcome measure)
Disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01043835 on ClinicalTrials.gov Archive Site
Complications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer:A Prospective Randomized Trial
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Stomach Neoplasm
  • Laparoscopy
  • Gastrectomy
  • Complications
  • Procedure: Laparoscopy-assisted gastrectomy
    A 10-mm trocar for laparoscope was inserted below the umbilicus. Another 10-mm trocar was introduced in the left preaxillary line 2 cm below the costal margin as a major hand port,and a 5-mm trocar was placed at the contralateral site for traction. A 5-mm trocar was inserted in the left midclavicular line 2 cm above the umbilicus as an accessory port, and a 15-mm trocar also as an accessory port was placed at the contralateral site. The operator stood on the left side of the patient. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction. Dissected stomach and lymph node are collected through additional 5 cm incision at a median superior abdominal incision.
  • Procedure: Open gastrectomy
    Approximately 15~20 cm length incision is made from falciform process to periumbilical area. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction for all cases.
  • Experimental: Laparoscopy-assisted gastrectomy
    Intervention: Procedure: Laparoscopy-assisted gastrectomy
  • Active Comparator: Open gastrectomy
    Intervention: Procedure: Open gastrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
328
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01043835
197691197392
Yes
Yan Shi, Southwest Hospital, China
Yan Shi
Not Provided
Not Provided
Southwest Hospital, China
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP