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

Primary Purpose

Stomach Neoplasm, Laparoscopy, Gastrectomy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopy-assisted gastrectomy
Open gastrectomy
Sponsored by
Yan Shi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring Stomach Neoplasm, Laparoscopy, gastrectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital
  • Southwest Hospital, China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopy-assisted gastrectomy

Open gastrectomy

Arm Description

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

Complications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22

Full Information

First Posted
January 6, 2010
Last Updated
June 4, 2012
Sponsor
Yan Shi
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1. Study Identification

Unique Protocol Identification Number
NCT01043835
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yan Shi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm, Laparoscopy, Gastrectomy, Complications
Keywords
Stomach Neoplasm, Laparoscopy, gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopy-assisted gastrectomy
Arm Type
Experimental
Arm Title
Open gastrectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy-assisted gastrectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Open gastrectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Complications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically proven gastric adenocarcinoma Age:older than 18 years old,younger than 80 years old Preoperative stage(CT, GFS stage):cT2N0M0, cT2N1M0, cT2N2M0, cT3N0M0, cT3N1M0,cT3N2M0 ASA score:≤3 Patients with an invasion of the gastric serosa exceeding 10 cm2 according to ultrasound examination or examination during surgery were excluded No history of other cancer No history of chemotherapy or radiotherapy Written informed consent Exclusion Criteria: Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy) ASA score:>3 Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy Complicated case needed to get emergency operation Any accompanying surgical condition needed to be performed in same time
Facility Information:
Facility Name
Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital
City
Chong Qing
State/Province
Chong Qing
ZIP/Postal Code
400038
Country
China
Facility Name
Southwest Hospital, China
City
Chong Qing
State/Province
Chong Qing
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

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

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