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

Yonsei University

Status: Enrolling

Conditions: Gastric Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03385018

4-2017-0940

Details and patient eligibility

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.

Enrollment: 772 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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772 participants in 2 patient groups

Laparoscopic group

Experimental group

Description:

Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection

Treatment:

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

Open group

Active Comparator group

Description:

Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection

Treatment:

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