Status:
RECRUITING
Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Lead Sponsor:
Yonsei University
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
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 limi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
772 Patients enrolled
Trial Details
Trial ID
NCT03385018
Start Date
April 5 2018
End Date
December 31 2027
Last Update
March 19 2019
Active Locations (1)
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1
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Seoul, South Korea, 120-752