Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)

Not Applicable

Recruiting

Interventions: Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach
Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach

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 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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Laparoscopic group	Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach	Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection
Open group	Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach	Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection

Primary Outcome Measures

Name	Time	Method
3 year relapse-free survival	3 years after surgery	Non-inferiority of 3 year relapse-free survival rate after laparoscopic radical total gastrectomy and lymphadenectomy for locally advanced gastric cancer comparing with open conventional surgery. The "event" of relapse-free survival is defined as "recurrence" after 4 weeks of operation. The "censoring" is defined as non-traceable patient who cannot be confirmed with recurrence or patient who are alive without recurrence until follow-up. The "relapse-free survival time" is defined as the time from surgery to "event" or "censoring".

Secondary Outcome Measures

Name	Time	Method
3 year overall survival rate	3 years after surgery
5 year relapse-free and overall survival	5 years after surgery
Morbidity (early period)	from Operation day until POD 21
Morbidity (late period)	from POD (Post-Operative Day) 22 until 5 years after surgery
Mortality	at POD 90	death with any cause
Quality of life(EORTC QLQ-C30)	12 months after surgery	Quality of life measured by EORTC QLQ-C30(Version 3)
Quality of life(EORTC QLC STO22)	12 months after surgery	Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).

Locations (1): Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
🇰🇷
Seoul, Korea, Republic of