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

NCT ID: NCT03385018

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 772 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2027-12-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic group

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

• 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 splenectomy
• Indwelling nasogastric tube and drainage catheter at surgeons discretion
• D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection

Open group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

• 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 should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection

Interventions

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 splenectomy
• Indwelling nasogastric tube and drainage catheter at surgeons discretion
• D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection

Intervention Type: 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 should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Woo Jin Hyung, MD, PhD

Role: CONTACT

wjhyung@yuhs.ac

+82-2-2228-2100

Facility Contacts

Woo Jin Hyung, MD

Role: primary

WJHYUNG@yuhs.ac

+82-2-2228-2100

Other Identifiers

4-2017-0940

Identifier Type: -

Identifier Source: org_study_id