Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy with Lymph Node Dissection for Gastric Cancer (KLASS-06)

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0003095
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 772

Inclusion Criteria

1) Patients who are over 20 and below 80 years old
2) Patients who have performance status of ECOG 0 or 1
3) Patients with American Society of Anesthesiology score of class I to III
4) Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
5) Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (clinical T2 ~ clinical T4a)
6) Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (clinical N0 ~ clinical N2)
7) Patients with tumors which can be curatively resected by total gastretomy with D2 (or D2-#10) lymph node dissection based on preoperative study
8) Patients who agree with participating in the clinical study with informed consents
9) Patients who can be followed for at least 3 years after study enrollment

Exclusion Criteria

1) Patients who have possibility of distant metastasis in preoperative studies
2) Patients who have history of gastric resection with any cause
3) Patients who have complications (bleeding or obstruction) of gastric cancer
4) Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
5) Patients who are diagnosed and treated with other malignancies within 5 years
6) Vulnerable patients
7) Patients who participating or participated in other clinical trial within 6 months
8) Patients who have active synchronous cancer

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year relapse-free survival

Secondary Outcome Measures

Name	Time	Method
3-year and 5-year overall survival;5-year relapse-free survival;Quality of Life score using EORTC C-30, Sto-22 questionnaire;Postoperative recovery;Leakage rate of esophagojejunostomy, duodenal stump;Postoperative complication;Postoperative mortality