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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

• 3 year relapse-free survival [Срок оценки: 3 years after surgery]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

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

Идентификаторы

NCT: NCT03385018 · 4-2017-0940

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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