RecruitingNot ApplicableNCT03385018

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

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

Sponsor

Yonsei University

Enrollment

772 participants

Start Date

Apr 5, 2018

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer

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.

Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating whether performing a total stomach removal (total gastrectomy) using laparoscopic (minimally invasive, keyhole) surgery is as safe and effective as traditional open surgery for patients with stomach cancer that has grown into the muscle layer of the stomach. **You may be eligible if...** - You are between 20 and 80 years old - You are in good overall health (ECOG performance status 0 or 1) and considered fit for anesthesia - You have been diagnosed with stomach cancer (gastric adenocarcinoma) not involving the junction between the stomach and esophagus, confirmed by endoscopy and biopsy - The cancer appears to be surgically removable and has not yet invaded adjacent organs (stage cT2 to cT4a) - You have provided written informed consent **You may NOT be eligible if...** - The cancer involves the area where the stomach meets the esophagus - The cancer has spread to nearby organs or distant sites - You have had previous stomach surgery or treatments that affect eligibility - Your overall health is too poor for the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERadical 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

PROCEDURERadical 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

Locations(1)

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

Seoul, South Korea

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