Actively Recruiting
Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Led by Yonsei University · Updated on 2019-03-19
772
Participants Needed
1
Research Sites
508 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses. Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery. Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.
CONDITIONS
Official Title
Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are over 20 and below 80 years old
- Patients who have performance status of ECOG 0 or 1
- Patients with American Society of Anesthesiology score of class I to III
- Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
- Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
- Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 ~ cT4a)
- Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 ~ cN2)
- Patients who agree with participating in the clinical study with informed consents
- Patients who can be followed for at least 3 years after study enrollment
You will not qualify if you...
- Patients who have possibility of distant metastasis in preoperative studies
- Patients who have history of gastric resection with any cause
- Patients who have complications (bleeding or obstruction) of gastric cancer
- Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
- Patients who are diagnosed and treated with other malignancies within 5 years
- Vulnerable patients
- Patients who participating or participated in other clinical trial within 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Seoul, South Korea, 120-752
Actively Recruiting
Research Team
W
Woo Jin Hyung, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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