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Trial Title:
A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection
NCT ID:
NCT02311595
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
gastric cancer
laparoscope
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
reduced port laparoscopic distal gastrectomy
Arm group label:
reduced port
Summary:
The purpose of this study is to determine if reduced port totally laparoscopic distal
gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and
oncological feasible.
67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo
reduced port totally laparoscopic distal gastrectomy.
The primary end point of this study is to measure compliance rate with pathology report
and compare with previous compliance rate data.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- histologically confirmed adenocarcinoma of the stomach
- Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance
status 0-1,
- signed informed consent
- location of the primary tumor in the antrum, angle and lower body
- no evidence of distant metastasis or invasion to adjacent organs or serosal
infiltration
Exclusion Criteria:
- metastatic disease
- previous history of malignancy in any organ
- any co-morbidity obviating major surgery
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
December 2014
Completion date:
March 2015
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02311595
