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

Official title

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

Overview

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.

Interventions

• Procedure Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach
  * Total gastrectomy with D2(D2-10) lymph node dissection by laparoscopic approach * The number of trocars is 6 or less * Roux-en-Y esophagojejunostomy with any stapling method * Enough(negative) margin from tumor * LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined * Washing cytology * Frozen biopsy for surgical margin at surgeons discretion * Complete omentectomy for grossly serosa-involved tumor * Combined organ resection only in cholecystectomy and splenectom
• Procedure Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
  * Total gastrectomy with D2(D2-10) lymph node dissection by open conventional approach * Roux-en-Y esophagojejunostomy with any stapling method * Enough(negative) margin from tumor * LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined * Washing cytology * Frozen biopsy for surgical margin at surgeons discretion * Complete omentectomy for grossly serosa-involved tumor * Indwelling nasogastric tube and drainage catheter at surgeons discretion * D2 lymphadenectomy s

Primary outcome measures

• 3 year relapse-free survival [Time frame: 3 years after surgery]

Secondary outcome measures (12)

• 3 year overall survival rate [Time frame: 3 years after surgery]
• 5 year relapse-free and overall survival [Time frame: 5 years after surgery]
• Morbidity (early period) [Time frame: from Operation day until POD 21]
• Morbidity (late period) [Time frame: from POD (Post-Operative Day) 22 until 5 years after surgery]
• Mortality [Time frame: at POD 30]
• Mortality [Time frame: at POD 90]
• Quality of life(EORTC QLQ-C30) [Time frame: at POD 21]
• Quality of life(EORTC QLC STO22) [Time frame: at POD 21]
• Quality of life(EORTC QLQ-C30) [Time frame: 3 months after surgery]
• Quality of life(EORTC QLC STO22) [Time frame: 3 months after surgery]
• Quality of life(EORTC QLQ-C30) [Time frame: 12 months after surgery]
• Quality of life(EORTC QLC STO22) [Time frame: 12 months after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Department of Surgery, Yonsei University College of Medicine, Seoul, Korea — Seoul

Identifiers

NCT: NCT03385018 · 4-2017-0940

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗