Annals of surgery · 2024
Laparoscopic Pylorus-preserving Gastrectomy Versus Distal Gastrectomy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial (KLASS-04).
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Lee Hyuk-Joon, Kim Young-Woo, Park Do Joong, Han Sang Uk, Ryu Keun Won, Kim Hyung-Ho, Hyung Woo Jin, Park Ji-Ho, Suh Yun-Suhk, Kwon Oh-Kyung, Kim Wook, Park Young-Kyu, Yoon Hong Man, Ahn Sang-Hoon, Kong Seong-Ho, Yang Han-Kwang
Аннотация
OBJECTIVE: To evaluate the long-term outcomes of laparoscopic pylorus-preserving gastrectomy (LPPG) with laparoscopic distal gastrectomy (LDG) for early gastric cancer.
BACKGROUND: Pylorus-preserving gastrectomy is considered a function-preserving surgery for early gastric cancer. However, there has been no multicenter randomized controlled trial comparing pylorus-preserving gastrectomy with distal gastrectomy until now.
METHODS: A multicenter randomized controlled trial (KLASS-04) with 256 patients with cT1N0M0 gastric cancer located in the mid portion of the stomach was conducted. The primary endpoint was the incidence of dumping syndrome at postoperative 1 year. Secondary endpoints included survival and recurrence, gallstone formation, nutritional parameters, gastroscopic findings, and quality of life for 3 years.
RESULTS: In the intention-to-treat analyses, there was no difference in the incidence of dumping syndrome at 1 year postoperatively (13.2% in LPPG vs 15.8% in LDG, P = 0.622). Gallstone formation after surgery was significantly lower in LPPG than in LDG (2.33% vs 8.66%, P = 0.026). Hemoglobin (+0.01 vs -0.76 gm/dL, P < 0.001) and serum protein (-0.15 vs -0.35 gm/dL, P = 0.002) were significantly preserved after LPPG. However, reflux esophagitis (17.8% vs 6.3%, P = 0.005) and grade IV delayed gastric emptying (16.3% vs 3.9%, P = 0.001) were more common in LPPG. Changes in body weight and postoperative quality of life were not significantly different between groups. Three-year overall survival and disease-free survival were not different (1 case of recurrence in each group, P = 0.98).
CONCLUSIONS: LPPG can be used as an alternative surgical option for cT1N0M0 gastric cancer in the mid portion of the stomach.
BACKGROUND: Pylorus-preserving gastrectomy is considered a function-preserving surgery for early gastric cancer. However, there has been no multicenter randomized controlled trial comparing pylorus-preserving gastrectomy with distal gastrectomy until now.
METHODS: A multicenter randomized controlled trial (KLASS-04) with 256 patients with cT1N0M0 gastric cancer located in the mid portion of the stomach was conducted. The primary endpoint was the incidence of dumping syndrome at postoperative 1 year. Secondary endpoints included survival and recurrence, gallstone formation, nutritional parameters, gastroscopic findings, and quality of life for 3 years.
RESULTS: In the intention-to-treat analyses, there was no difference in the incidence of dumping syndrome at 1 year postoperatively (13.2% in LPPG vs 15.8% in LDG, P = 0.622). Gallstone formation after surgery was significantly lower in LPPG than in LDG (2.33% vs 8.66%, P = 0.026). Hemoglobin (+0.01 vs -0.76 gm/dL, P < 0.001) and serum protein (-0.15 vs -0.35 gm/dL, P = 0.002) were significantly preserved after LPPG. However, reflux esophagitis (17.8% vs 6.3%, P = 0.005) and grade IV delayed gastric emptying (16.3% vs 3.9%, P = 0.001) were more common in LPPG. Changes in body weight and postoperative quality of life were not significantly different between groups. Three-year overall survival and disease-free survival were not different (1 case of recurrence in each group, P = 0.98).
CONCLUSIONS: LPPG can be used as an alternative surgical option for cT1N0M0 gastric cancer in the mid portion of the stomach.