A Multi-institutional, Prospective, Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (JLSSG0901)

2015 ◽  
Vol 39 (11) ◽  
pp. 2734-2741 ◽  
Author(s):  
Noriyuki Inaki ◽  
Tsuyoshi Etoh ◽  
Tetsuji Ohyama ◽  
Kazuhisa Uchiyama ◽  
Natsuya Katada ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Advanced Gastric Cancer ◽  
Lymph Node Dissection ◽  
Distal Gastrectomy ◽  
Locally Advanced ◽  
Node Dissection ◽  
D2 Lymph Node Dissection ◽  
Locally Advanced Gastric Cancer ◽  
Prospective Phase

Short-term outcomes from a multi-institutional, phase III study of laparoscopic versus open distal gastrectomy with D2 lymph node dissection for locally advanced gastric cancer (JLSSG0901).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4029-4029 ◽  
Author(s):  
Sang-Woong Lee ◽  
Tsuyoshi Etoh ◽  
Tetsuji Ohyama ◽  
Noriyuki Inaki ◽  
Shinichi Sakuramoto ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Advanced Gastric Cancer ◽  
Lymph Node Dissection ◽  
Distal Gastrectomy ◽  
Locally Advanced ◽  
Node Dissection ◽  
Short Term ◽  
D2 Lymph Node Dissection ◽  
Locally Advanced Gastric Cancer

4029 Background: The safety of laparoscopic gastrectomy for advanced gastric cancer is controversial. We conducted a multi-institutional, randomized controlled trial to compare short- and long-term outcomes of laparoscopic distal gastrectomy (LAP) with D2 lymph node dissection for advanced gastric cancer in comparison to open distal gastrectomy (OP) in Japan (UMIN000003420). We herein demonstrate short-term outcomes of this trial. Methods: Patients with potentially curable gastric cancer (T2-T4, N0-2 and M0) by distal gastrectomy were eligible for inclusion. Between November 2009 and July 2016, 507 patients were randomly assigned to either the LAP group (n = 252) or the OP group (n = 255). Only credentialed surgeons in both the procedures from 37 Japanese institutions participated in the study. The primary endpoint was 5-year relapse free survival. Secondary endpoints were 5-year overall survival, adverse events and short-term clinical outcomes. Results: According to study protocol, 47 patients among the total eligible patients were excluded because of distant metastasis or tumor extension intraoperatively. The remaining 460 patients underwent distal gastrectomy with D2 lymph node dissection and were analyzed as per protocol. Estimated blood loss was lower in LAP than in OP (30 vs. 150 ml, P < 0.001) and operative time was longer in LAP than in OP (291 vs. 205 min, P < 0.001). Post-operative analgesics use was less in LAP than in OP (38.3 vs. 53.6 %, P = 0.001), and first day of flatus was shorter in LAP than in OP (2 vs. 3 days, P < 0.001). There were no significant differences in all grade intra-operative complications (LAP 0.9% vs. OP 2.6%, P = 0.285). In addition, there were no significant differences in grade 3 and higher post-operative complications between the two groups (LAP 3.1% vs. OP 4.7%, P = 0.473). Hospital mortality was 0.4 % in each group. Conclusions: Credentialed surgeons could safely perform laparoscopic distal gastrectomy with D2 lymph node dissection for locally advanced gastric cancer. The laparoscopic approach could be accepted without increasing major surgical complications in this setting. Clinical trial information: 000003420.

The quality of life (QoL) assessment of oxaliplatin-based preoperative chemotherapy for locally advanced gastric cancer: An integration analysis of two prospective phase I study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18263-e18263
Author(s):  
Hironaga Satake ◽  
Akira Miki ◽  
Hisateru Yasui ◽  
Akihito Tsuji
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Neoadjuvant Chemotherapy ◽  
Phase I ◽  
Advanced Gastric Cancer ◽  
Phase I Study ◽  
Locally Advanced ◽  
Node Dissection ◽  
Locally Advanced Gastric Cancer ◽  
Prospective Phase

e18263 Background: Surgery with lymph node dissection is the primary treatment for patients with localized resectable gastric cancer. However, the prognosis of locally advanced gastric cancer is poor. One promising approach is neoadjuvant chemotherapy, however, the use of neoadjuvant chemotherapy consisting of oxaliplatin-based regimen for locally advanced gastric cancer has not been reported. Oxaliplatin-induced neurotoxicity may continue after the chemotherapy and interfere with patients’ daily activities. We conducted two prospective phase I study of oxaliplatin-based neoadjuvant chemotherapy for locally advanced gastric cancer and assessed the oxaliplatin-induced neuropathy using the FACT-Ga and FACT-GOG-Ntx assessments. Methods: We planned two cycles of oxaliplatin administration and evaluated oxaliplatin-induced neuropathy using the FACT-Ga and FACT-GOG-Ntx assessments. Patients with locally advanced gastric cancer received two cycles of neoadjuvant chemotherapy with oxaliplatin (100 or 130 mg/m2) on day 1, as well as S-1 (80 mg/m2/day, b.i.d.) or capecitabine (2000 mg/m2/day, b.i.d.) for 14 days, repeated every 3 weeks. They then underwent gastrectomy with curative D2/3 lymph-node dissection followed by adjuvant S-1 (80 mg/m2/day, b.i.d.) for one year. QoL was assessed at baseline and during treatment. Results: Twelve patients were enrolled and fully assessed the QoL. All patients were chmo-naïve and had a good performance status: median age 70y, 67% male. The mean dose intensity of delivered during the neoadjuvant chemotherapy was 96.0% for oxaliplatin. Peripheral neuropathy was observed in all patients but with no functional disorders. Median time to QoL deterioration in FACT-G and FACT-GOG-NTx was 3 weeks. There were correlation between oxaliplatin administration and QoL deterioration by the repeated-measures ANOVA. Conclusions: FACT-GOG-Ntx showed that sensory neuropathy caused a deterioration in QoL immediately after the initiation of preoperative oxaliplatin-based chemotherapy, but that QoL recovered after the neo-adjuvant chemotherapy. Clinical trial information: UMIN000015950,UMIN000015181.

Result of clinical study on feasibility of laparoscopy-assisted D2 distal gastrectomy to treat advanced gastric cancer (COACT_1001).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4105-4105 ◽  
Author(s):  
Young Woo Kim ◽  
Young-Kyu Park ◽  
Hong Man Yoon ◽  
Byung-Ho Nam ◽  
Keun Won Ryu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Advanced Gastric Cancer ◽  
Lymph Node Dissection ◽  
Distal Gastrectomy ◽  
Perioperative Complications ◽  
Clinical Stage ◽  
Compliance Rate ◽  
Node Dissection ◽  
D2 Lymph Node Dissection

4105 Background: Benefit of quality of life made laparoscopic gastric cancer surgery attractive, but there are still concerns about laparoscopic lymph node dissection. The aim of this study was to evaluate a feasibility of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection compared with open distal gastrectomy (ODG) for advanced gastric cancer (AGC). Methods: Patients with cT2-T4a and cN0-2 (AJCC 7th staging system) distal gastric cancer were randomly assigned to LADG or ODG. The primary endpoint was the non-compliance rate of the lymph node dissection defined as rate of cases where there was more than one missing lymph node station according to the guidelines of the Japanese Research Society for Gastric Cancer lymph node grouping. Secondary endpoints were perioperative complications, changes of inflammatory and immunological parameters, postoperative hospital stay, and 3 year disease free survival. This trial was registered at ClinicalTrials.gov as NCT01088204. Results: Between Jun 2010 and Oct 2011,204 patients were randomly allocated and underwent either LADG (n=105) or ODG (n=99). 8 patients were excluded in the intention to treatment analysis because of protocol violation and patient’s withdrawal of permission, and finally 100 patients in LADG and 95 patients in ODG were analyzed. There were no significant differences of overall non-compliance rate of lymph node dissection between LADG and ODG groups; they were respectively 47.0% and 43.2%. (p=0.648). In the subgroup analysis according to the stratified risk groups, non-compliance rate in LADG was significantly higher than ODG (52.0% vs. 25.0%, p=0.043) for clinical stage III but it was not significantly different for stage II (46.2% vs. 48.9%, p=0.788). Intraoperative event rate was not significantly different between groups (LADG;6.0% and ODG;4.2%, p =0.748). Complications rate in early postoperative period up to 1 month was also not different between groups (LADG;17.0 %, ODG;18.8%, p=0.749). Conclusions: LADG was feasible in AGC compared with ODG, especially in clinical stage II in terms of non-compliance rate of D2 lymph node dissection and perioperative complications. Clinical trial information: NCT01088204.

scholarly journals Comparison of laparoscopic versus open gastrectomy with D2 lymph node dissection for advanced gastric cancer: A meta-analysis

2019 ◽  
Vol 1 (2) ◽  
pp. 110-121
Author(s):  
Sandrie Mariella Mac ◽  
Ashish Bahadur Malla
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Advanced Gastric Cancer ◽  
Lymph Node Dissection ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Open Gastrectomy ◽  
Long Term Results ◽  
Node Dissection ◽  
D2 Lymph Node Dissection

For many decades, D2 procedure has been accepted in the far-east as the standard treatment for both early (EGC) and advanced gastric cancer (AGC). In case of AGC, the debate on the extent of nodal dissection has been open for many years in order to highlight the safety and efficacy of treatment, hence this study. A comprehensive literature research was performed in PubMed to identify studies that compared laparoscopic- assisted gastrectomy (LAG) and open gastrectomy (OG) with D2 lymph node dissection (D2-LND) for treatment of AGC for the last five years. Data of interest were checked and subjected to meta-analysis with RevMan 5.3 software. The pooled risk ratios (RR) and weighted mean difference (WMD) with 95% confidence intervals (CI) were calculated. Overall, 19 studies were included in this meta-analysis. LG had some advantages over OG, including shorter hospitalization (WMD -2.31; 95% CI -4.09 to -0.53; P = 0.01), less blood loss (WMD -120.49; 95% CI -174.27 to -66.71; P < 0.01), faster bowel recovery (WMD -0.55; 95% CI -0.86 to -0.24; P ˂ 0.01) and earlier ambulation (WMD -0.75; 95% CI -1.38 to -0.11; P = 0.02). In terms of surgical and oncological safety, LG could achieve similar lymph nodes (WMD, -0.94, 95% CI, -2.95 to 1.06; P=0.36), a lower complication rate [odds ratio (OR)=0.80; 95%CI, 0.68-0.97; P=0.02], and overall survival (OS) and disease-free survival (DFS) comparable to OG. In conclusion, for AGCs both techniques (LAG and OG) appeared comparable in short- and long-term results. More time was needed to perform LAG; nonetheless, it had some advantages in achieving faster postoperative recovery over OG. In order to clarify this controversial issue ongoing trials and future studies are needed.

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