Hur Hoon, Lee Hyun Yong, Lee Hyuk-Joon, Kim Min Chan, Hyung Woo Jin, Park Young Kyu, Kim Wook, Han Sang-Uk
Department of Surgery, Ajou University Medical Center, Ajou University School of Medicine, 206 Worldcup-ro, Youngtong-gu, Suwon, 443-749, Korea.
Clinical Trial Center, Ajou University Medical Center, Ajou University School of Medicine, Suwon, 443-749, Korea.
BMC Cancer. 2015 May 5;15:355. doi: 10.1186/s12885-015-1365-z.
Despite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial.
METHODS/DESIGN: This trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2-cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial.
This clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure.
ClinicalTrial.gov, NCT01456598.
尽管腹腔镜手术在胃癌手术中具有诸如术中失血少和术后恢复快等诸多已被充分描述的益处，但由于缺乏临床证据，腹腔镜手术在局部进展期胃癌（AGC）患者中的应用仍不明确。最近，韩国腹腔镜外科学会组开展了一项新的多中心随机临床试验（RCT），以比较腹腔镜与开放D2淋巴结清扫术治疗局部AGC患者的疗效。在此，我们介绍该临床试验的方案。
方法/设计：本试验是一项由研究者发起的随机、对照、平行组、非劣效性试验。招募术前研究诊断为原发性肿瘤侵犯固有肌层但未侵犯相邻器官（cT2 - cT4a）的胃癌患者。另一个入选标准是无淋巴结转移或胃周淋巴结（包括胃左动脉周围淋巴结）转移局限。两组共需要1050例患者，以从统计学上显示腹腔镜手术在主要终点即3年无复发生存方面不劣于开放手术。次要结局包括术后发病率和死亡率、术后恢复情况、生活质量和总生存期。经手术视频同行评审验证的外科医生可参与本临床试验。
本临床试验旨在为参与的外科医生维持具有内部有效性的外科临床试验原则。通过KLASS - ０２RCT，我们希望证明与开放手术相比，腹腔镜D2淋巴结清扫术在AGC患者中的疗效。
ClinicalTrial.gov，NCT01456598。
