Comparison of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer:A Prospective Randomized Trial
|ClinicalTrials.gov Identifier: NCT01043835|
Recruitment Status : Unknown
Verified June 2012 by Yan Shi, Southwest Hospital, China.
Recruitment status was: Active, not recruiting
First Posted : January 7, 2010
Last Update Posted : June 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasm Laparoscopy Gastrectomy Complications||Procedure: Laparoscopy-assisted gastrectomy Procedure: Open gastrectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||328 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prospective Randomized Trial of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||February 2015|
|Experimental: Laparoscopy-assisted gastrectomy||
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.
|Active Comparator: Open gastrectomy||
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.
- Disease free survival [ Time Frame: 3 years ]
- Complications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22 [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043835
|China, Chong Qing|
|Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital|
|Chong Qing, Chong Qing, China, 400038|
|Southwest Hospital, China|
|Chong Qing, Chong Qing, China, 400038|