Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912

Abstract

Backgrounds No confirmatory randomized controlled trials (RCTs) have evaluated the efficacy of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG). We performed an RCT to confirm that LADG is not inferior to ODG in efficacy. Methods We conducted a multi-institutional RCT. Eligibility criteria included histologically proven gastric adenocarcinoma in the middle or lower third of the stomach, clinical stage I tumor. Patients were preoperatively randomized to ODG or LADG. This study is now in the follow-up stage. The primary endpoint is relapse-free survival (RFS) and the primary analysis is planned in 2018. Here, we compared the surgical outcomes of the two groups. This trial was registered at the UMIN Clinical Trials Registry as UMIN000003319.Results Between March 2010 and November 2013, 921 patients (LADG 462, ODG 459) were enrolled from 33 institutions. Operative time was longer in LADG than in ODG (median 278 vs. 194 min, p \ 0.001), while blood loss was smaller (median 38 vs. 115 ml, p \ 0.001). There was no difference in the overall proportion with in-hospital grade 3-4 surgical complications (3.3 %: LADG, 3.7 %: ODG). The proportion of patients with elevated serum AST/ALT was higher in LADG than in ODG (16.4 vs. 5.3 %, p \ 0.001). There was no operation-related death in either arm. Conclusions This trial confirmed that LADG was as safe as ODG in terms of adverse events and short-term clinical outcomes. LADG may be an alternative procedure in clinical IA/IB gastric cancer if the noninferiority of LADG in terms of RFS is confirmed.

Short-term surgical outcomes of laparoscopy-assisted versus open D2 distal gastrectomy for locally advanced gastric cancer in North China: a multicenter randomized controlled trial

“…The well-known advantages of LADG reported in EGC patients [5, 6], such as less blood loss and faster postoperative recovery was confirmed in this trial again. Due to the magnified surgical field and more meticulous surgical procedures, unexpected bleeding and excessive distraction could be prevented efficiently.…”

“…Some well-designed multicenter randomized controlled trials (RCTs) from Japan (JCOG0912 [5]) and Korea (KLASS-01 [6]) revealed that LADG was just as safe as conventional ODG in terms of short-term clinical outcomes for stage I gastric cancer, even with significantly lower overall complication rate [6]. Furthermore, the long-term outcomes of EGC patients undergoing LADG were proven comparable to those of patients treated by ODG from a single-arm, multi-institutional clinical trial (JCOG0703 [7]).…”

Randomized controlled trials evaluating laparoscopic vs. open distal gastrectomy for gastric cancer in 2016: a trilogy finally!

“…Recently, Katai and colleagues of the Japan Clinical Oncology Group (JCOG0912) confirmed the noninferiority and safety of LADG compared to ODG in terms of short-term adverse and clinical outcomes of 912 early gastric cancer patients (LADG: 457 and ODG: 455 patients) (12 groups were published, in which both studies concluded the non-inferiority of laparoscopic surgeries in early and advanced gastric cancer, respectively (13,14).…”

Validity of Laparoscopic Gastrectomy in the Elderly

“…Large clinical trials demonstrated the advantages of laparoscopic gastrectomy over open gastrectomy, including less blood loss, sooner bowel movement recovery, shorter hospital stay, and a similar or lower postoperative morbidity rate [7,21]. However, these trials included a small proportion of elderly patients.…”

“…Consequent-ly, the 12th nationwide survey of endoscopic surgery in Japan showed that the number of laparoscopic gastric cancer surgeries, including laparoscopic distal gastrectomy with extended lymphadenectomy and total gastrectomy, has been gradually increasing [5]. However, the median age of participants in clinical trials exploring the validity of laparoscopic surgery for gastric cancer is approximately 60 years, suggesting that the proportion of elderly patients in the trials is low [4,6,7]; moreover, their results do not sufficiently reflect the laparoscopic surgery outcomes of elderly patients. In addition, some authors have reported the short-term outcomes of laparoscopic gastrectomy in elderly patients [8,9]; however, only a few have investigated the long-term outcomes [10,11].…”