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

NARecruitingINTERVENTIONAL
Enrollment

772

Participants

Timeline

Start Date

April 5, 2018

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2027

Conditions
Gastric Cancer
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 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"

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"

Trial Locations (1)

120-752

RECRUITING

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

All Listed Sponsors
lead

Yonsei University

OTHER