Back to resultsSingle-center Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic gastrectomy
Open gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Age from over 18 to under 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) score class I, II, or III Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging History of other malignant disease within past five years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of predicted values
Sites / Locations
- The Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoscopic gastrectomy
Open gastrectomy
Arm Description
Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Outcomes
Primary Outcome Measures
3-year disease free survival rate
Secondary Outcome Measures
Morbidity
3-year overall survival rate
3-year recurrence pattern
Mortality
Morbidity
Mortality
Postoperative recovery situation
Time to first ambulation, flatus, liquid diet, soft diet and duration of hospital stay are used to assess the postoperative recovery situation.
Full Information
NCT ID
NCT02219854
First Posted
August 14, 2014
Last Updated
March 4, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02219854
Brief Title
Single-center Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric cancer is popular in East Asian countries. However, the long-term follow-up outcome based on randomized clinical trial (RCT) is still rare. Some studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is still limited because of lack of solid evidence on the oncologic efficacy. Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 percent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.Accordingly, the comparison of long-term outcome between laparoscopic and open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer based on a well designed RCT is needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic gastrectomy
Arm Type
Experimental
Arm Description
Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Arm Title
Open gastrectomy
Arm Type
Active Comparator
Arm Description
Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Open gastrectomy
Primary Outcome Measure Information:
Title
3-year disease free survival rate
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
30 days
Title
3-year overall survival rate
Time Frame
36 months
Title
3-year recurrence pattern
Time Frame
36 months
Title
Mortality
Time Frame
30 days
Title
Morbidity
Time Frame
36 months
Title
Mortality
Time Frame
36 months
Title
Postoperative recovery situation
Description
Time to first ambulation, flatus, liquid diet, soft diet and duration of hospital stay are used to assess the postoperative recovery situation.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from over 18 to under 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) score class I, II, or III Written informed consent
Exclusion Criteria:
Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging History of other malignant disease within past five years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of predicted values
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongbo Wei, M.D. Ph.D.
Phone
+86-189-2210-2969
Email
drweihb@126.com
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbo Wei, M.D., Ph.D.
Phone
8613760660785
First Name & Middle Initial & Last Name & Degree
Hongbo Wei, M.D.,Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Single-center Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer
We'll reach out to this number within 24 hrs