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A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, laparoscope
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: reduced port laparoscopic distal gastrectomy
Type: Procedure
Overall Status
Not yet recruiting
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.
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
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
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
- 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
Location
Start Date
December 2014
Completion Date
March 2015
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page