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Trial Title:
Single-center Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer
NCT ID:
NCT02219854
Condition:
Stomach Neoplasms
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic gastrectomy
Arm group label:
Laparoscopic gastrectomy
Intervention type:
Procedure
Intervention name:
Open gastrectomy
Arm group label:
Open gastrectomy
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.
Criteria for 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
Gender:
All
Minimum age:
19 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Third Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510630
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongbo Wei, M.D., Ph.D.
Phone:
8613760660785
Investigator:
Last name:
Hongbo Wei, M.D.,Ph.D.
Email:
Principal Investigator
Start date:
July 2014
Completion date:
July 2020
Lead sponsor:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Source:
Third Affiliated Hospital, Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02219854
