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
  Purpose

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


Condition Intervention
Stomach Neoplasm
Laparoscopy
Gastrectomy
Complications
Procedure: Laparoscopy-assisted gastrectomy
Procedure: Open gastrectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 328
Study Start Date: February 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043835

Locations
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
Sponsors and Collaborators
Yan Shi
  More Information

No publications provided

Responsible Party: Yan Shi, Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01043835     History of Changes
Other Study ID Numbers: 197691197392
Study First Received: January 6, 2010
Last Updated: June 4, 2012
Health Authority: China: Ministry of Health

Keywords provided by Southwest Hospital, China:
Stomach Neoplasm
Laparoscopy
gastrectomy

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 23, 2014