Open Distal Gastrectomy Group Research Articles

Low incidence of postoperative infectious complications following laparoscopic distal gastrectomy for locally advanced gastric cancer in older adult patients above 75 years: Propensity score-matched comparison with open distal gastrectomy.

This study compared the short-term outcomes of older adult patients with locally advanced gastric cancer who underwent open distal gastrectomy (ODG) with those who underwent laparoscopic distal gastrectomy (LDG) using propensity score matching analysis. Overall, 341 consecutive older adult patients aged 75 years with gastric cancer who underwent ODG or LDG between January 2013 and December 2020 were retrospectively assessed. Among them, 121 patients with locally advanced gastric cancer were included. To compare short-term outcomes, a 1:1 propensity score matching analysis was performed. After matching, 29 patients were included in both groups. Compared with the ODG group, the LDG group had a longer operative time (mean, 290 vs. 190 min; p < .0001) and lower estimated blood loss (mean, 39 vs. 223 mL; p < .0001). Overall postoperative complications of grade 2 and higher were observed in 2 (6.9%) and 12 (41%) patients in the LDG and ODG groups, respectively (p = .0046). Of these, the LDG group had a significantly lower incidence rate of infectious complications than the ODG group (3.4% vs. 27.6%; p = .025). Furthermore, in multivariate analysis, the laparoscopic approach was an independent protective factor against postoperative complications (p = .029). LDG is safe and feasible for locally advanced gastric cancer in patients aged ≥75 years. Moreover, it may be a promising alternative to ODG with better short-term outcomes, including significantly lower incidence rates of postoperative complications.

Long-term outcomes of laparoscopic versus open distal gastrectomy for patients with advanced gastric cancer in North China: a multicenter randomized controlled trial

BackgroundLaparoscopic distal gastrectomy (LDG) has become a common procedure for treating advanced gastric cancer (AGC) in China. However, there is uncertainty regarding its oncological outcomes compared to open distal gastrectomy (ODG). This study aims to compare the 3-year disease-free survival (DFS) rates among patients who underwent surgery for AGC in northern China.MethodsA multicenter, non-inferiority, open-label, parallel, randomized clinical trial was conducted to evaluate patients with AGC who were eligible for distal gastrectomy at five tertiary hospitals in North China. In this trial, patients were randomly assigned preoperatively to receive either LDG or ODG in a 1:1 allocation ratio. The primary endpoint was postoperative morbidity and mortality within 30 days and the secondary endpoint was the 3-year DFS rate. This trial has been registered at ClinicalTrials.gov (Identifier: NCT02464215).ResultsA total of 446 patients were randomly allocated to LDG (n = 223) or ODG group (n = 223) between March 2014 and August 2017. After screening, a total of 214 patients underwent the open surgical approach, while 216 patients underwent laparoscopic surgery. The 3-year DFS rate was 85.9% for the LDG group and 84.72% for the ODG group, with no significant statistical difference (Hazard ratio 1.12; 95% CI 0.68–1.84, P = 0.65). Body mass index (BMI) < 25 kg/m2, advanced pathologic T4, and pathologic N2-3 category were confirmed as independent risk factors for DFS in the Cox regression.ConclusionsIn comparison to ODG, LDG with D2 lymphadenectomy yielded similar outcomes in terms of 3-year DFS rates among patients diagnosed with AGC.

Comparison of robotic versus laparoscopic versus open distal gastrectomy for locally advanced gastric cancer: a prospective trial-based economic evaluation.

It is largely unclear whether robotic distal gastrectomy (RDG) is cost-effective for locally advanced gastric cancer (LAGC). To evaluate the cost-effectiveness of RDG, laparoscopic distal gastrectomy (LDG), and open distal gastrectomy (ODG) for patients with LAGC. Inverse probability of treatment weighting (IPTW) was used to balance baseline characteristics. A decision-analytic model was constructed to evaluate the cost-effectiveness of RDG, LDG, and ODG. RDG, LDG, and ODG. Incremental cost-effectiveness ratio (ICER) and quality-adjusted life year (QALY). This pooled analysis of two randomized controlled trials included 449 patients: 117, 254, and 78 patients in the RDG, LDG, and ODG groups, respectively. After IPTW, RDG demonstrated its priority in terms of less blood loss, postoperative length, and complication rate (all P < 0.05). RDG also showed higher QOL with more cost, representing an ICER of $85,739.73 per QALY and $42,189.53 per QALY compared to LDG and ODG, respectively. In probabilistic sensitivity analysis, RDG achieved the best cost-effectiveness for patients with LAGC only when the willingness-to-pay threshold was > $85,739.73 per QALY, which significantly exceeded 3 times Chinese per capita GDP. Furthermore, one of the most important factors was the indirect costs of robotic surgery in terms of the cost-effectiveness of RDG compared to that of LDG or ODG. Although improved short-term outcomes and QOL were seen in patients underwent RDG, the economic burden should be considered in the clinical decision-making regarding robotic surgery use for patients with LAGC. Our findings may vary in different health care settings and affordability. Trial registrationCLASS-01 trial (ClinicalTrials.gov, CT01609309) and FUGES-011 trial (ClinicalTrials.gov, NCT03313700).

Five-Year Survival Outcomes of Laparoscopy-Assisted vs Open Distal Gastrectomy for Advanced Gastric Cancer

Evidence of implementation of laparoscopic gastrectomy for locally advanced gastric cancer is currently insufficient, as the primary end point in previous prospective studies was evaluated at a median follow-up time of 3 years. More robust evidence is necessary to verify noninferiority of laparoscopic gastrectomy. To compare 5-year survival outcomes between laparoscopy-assisted distal gastrectomy (LADG) and open distal gastrectomy (ODG) with D2 lymph node dissection for locally advanced gastric cancer. This was a multicenter, open-label, noninferiority, prospective randomized clinical trial. Between November 26, 2009, and July 29, 2016, eligible patients with histologically proven gastric carcinoma from 37 institutes in Japan were enrolled. Two interim analyses and final analysis were performed in October 2014, May 2018, and November 2021, respectively. Patients were randomly assigned (1:1) to either the ODG or LADG group. The procedures were performed exclusively by qualified surgeons. The primary end point was 5-year relapse-free survival, and the noninferiority margin for the hazard ratio (HR) was set at 1.31. The secondary end points were 5-year overall survival and safety. A total of 502 patients were included in the full-analysis set: 254 (50.6%) in the ODG group and 248 (49.4%) in the LADG group. Patients in the ODG group had a median (IQR) age of 67 (33-80) years and included 168 males (66.1%). Patients in the LADG group had a median (IQR) age of 64 (34-80) years and included 169 males (68.1%). No significant differences were observed in severe postoperative complications between the 2 groups in the safety analysis (ODG, 4.7% [11 of 233] vs LADG, 3.5% [8 of 227]; P = .64). The median (IQR) follow-up for all patients after randomization was 67.9 (60.3-92.0) months. The 5-year relapse-free survival was 73.9% (95% CI, 68.7%-79.5%) and 75.7% (95% CI, 70.5%-81.2%) for the ODG and LADG groups, respectively, and the HR was 0.96 (90% CI, 0.72-1.26; noninferiority 1-sided P = .03). Further, no significant difference was observed in overall survival time between the 2 groups, and the HR was 0.83 (95% CI, 0.57-1.21; P = .34). The pattern of recurrence was similar between the 2 groups. Results of this study show that on the basis of 5-year follow-up data, LADG with D2 lymph node dissection for locally advanced gastric cancer, when performed by qualified surgeons, was proved noninferior to ODG. This laparoscopic approach could become a standard treatment for locally advanced gastric cancer. UMIN Clinical Trial Registry: UMIN000003420.

Long-Term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer: A Propensity Score-Matched Cohort Study.

Laparoscopic gastrectomy for advanced gastric cancer (GC) has been applied more frequently worldwide but is still controversial for patients with serosal invasion (T4a). This study compared short- and long-term outcomes of laparoscopic distal radical gastrectomy (LDG) with open distal gastrectomy (ODG) for T4a GC. We retrospectively studied 472 patients with T4a gastric adenocarcinoma in the lower or middle third of the stomach: 231 underwent LDG and 241 underwent ODG between 2013 and 2020. Short-term outcomes included operative characteristics and complications. Long-term outcomes included overall survival (OS) and disease-free survival (DFS). Propensity score-matched (PSM) analysis was used to adjust for imbalances in baseline characteristics between groups. The PSM strategy resulted in 294 patients (147 in each group). The LDG group had a significantly longer operating time (mean: 200 vs 190 min, p = 0.001) but reduced blood loss (mean: 50 vs 100 ml, p = 0.001). The LDG group had a higher rate of any postoperative complication (23.1% vs 12.2%, p = 0.021) but most were classified as grades I-II according to Clavien-Dindo classification. Grade III-V complications were similar between groups. Five-year OS was 69% versus 60% (p = 0.109) and 5-year DFS was 58% vs 53% (p = 0.3) in LDG and ODG groups, respectively. For tumor size < 5 cm, LDG was better in reduction of blood loss, postoperative hospital length of stay, and OS. LDG is feasible and safe for patients with T4a GC and is comparable to ODG regarding short- and long-term outcomes. Furthermore, LDG can be a favorable option for T4a GC smaller than 5 cm.

The Influences of Obesity in Laparoscopic and Open Distal Gastrectomy for Patients with Early Gastric Cancer.

A recent increase in the number of surgeries performed on obese patents has raised several issues. In this study, we examined the effects of obesity on laparoscopic and open distal gastrectomy. A total of 262 patients with gastric cancer (cStage I) who underwent distal gastrectomy were classified into open distal gastrectomy (ODG) (145 patients) and laparoscopic distal gastrectomy (LDG) (117 patients) groups. According to their body mass index (BMI), they were subdivided into obese (BMI ≥ 25) and non-obese patients (BMI < 25) to examine the duration of surgery, blood loss, the number of lymph node dissections, postoperative hospital stay, and incidence of postoperative complications. The duration of surgery was longer and blood loss was higher for obese patients than for non-obese patients in both groups. The results for these two endpoints were significantly reduced in the LDG group than in the ODG group both in obese and non-obese patients. Furthermore, the number of lymph nodes dissected tended to be higher in the LDG group than in the ODG group in obese patients. Postoperative hospital stay was not significantly different between obese and non-obese patients in both groups, but was significantly shorter in the LDG group than in the ODG group regardless of the body weight. The incidence of postoperative complications was significantly higher in obese patients than in non-obese patients, although the difference between the groups was not significant. These findings indicate that LDG may be useful for obese patients with cStage I gastric cancer.

Open distal gastrectomy versus laparoscopic distal gastrectomy for early gastric cancer: a retrospective study.

Laparoscopic distal gastrectomy (LDG) is gaining popularity because its early postoperative effect has been shown to be better than open distal gastrectomy (ODG). However, to our knowledge, there are no studies demonstrating ODG is oncologically equivalent to LDG. This is a retrospective study based on the prospectively maintained database of the People's Hospital of Jinan City. Patients with operable, pathologically confirmed early-stage gastric cancer were included, while those with advanced disease or carcinoma in situ were excluded. Extracted data included age, body mass index (BMI), sex, clinical TNM stage, and pathologic stage. The primary outcome was 5-year overall survival, and the secondary outcomes included cancer-specific survival, cost-effectiveness, and quality of life. A total of 126 patients were finally enrolled and included 61 in the ODG group and 65 in the LDG group. Baseline clinical and pathological characteristics were generally balanced between the two groups. After a median follow-up of 8.31 years, the 5-year overall survival rate was estimated to be 82.8% (95% CI: 69.4-90.7%) for the ODG group and 86.7% (95% CI: 73.9-93.5%) for the LDG group and the recurrence patterns were similar between the two groups. Our data showed that the surgical results of both approaches are satisfactory, and LDG offers a reasonable option to ODG in patients with early gastric cancer.

Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer

It is not clear whether laparoscopic and open distal gastrectomy produce similar outcomes among patients with locally advanced gastric cancer. Data from a multicenter, randomized clinical trial (Chinese Laparoscopic Gastrointestinal Surgical Study [CLASS]-01) showed that laparoscopic distal gastrectomy did not result in inferior disease-free survival at 3 years compared with open distal gastrectomy. To report 5-year overall survival data from the CLASS-01 trial of laparoscopic vs open distal gastrectomy among patients with locally advanced gastric cancer. This was a noninferiority, open-label, randomized clinical trial conducted at 14 centers in China. A total of 1056 eligible patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 12, 2012, to December 3, 2014. Final follow-up was on December 31, 2019. Participants were randomized in a 1:1 ratio after stratification by site, age, cancer stage, and histologic features to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy. The 5-year overall survival rates were updated to compare laparoscopic distal gastrectomy with open distal gastrectomy. All analyses were performed on an intention-to-treat basis. In addition, per-protocol and as-treated analyses were performed for overall survival. Data from 1039 patients (726 men [69.9%]; mean [SD] age, 56.2 [10.7] years) who received curative therapy were analyzed. At 5 years, the overall survival rates were 72.6% in the laparoscopic distal gastrectomy group and 76.3% in the open distal gastrectomy group (log-rank P = .19; hazard ratio, 1.17; 95% CI, 0.93-1.48; P = .19). After comparison for competing risk events, gastric cancer-related deaths (hazard ratio, 1.14; 95% CI, 0.87-1.49; P = .34) and deaths from other causes (hazard ratio, 1.23; 95% CI, 0.74-2.05; P = .42) did not differ significantly between groups. Overall rates of survival did not differ significantly between groups with each tumor stage. This study found that laparoscopic distal gastrectomy with D2 lymphadenectomy performed by experienced surgeons in high-volume specialized institutions resulted in similar 5-year overall survival compared with open distal gastrectomy among patients with locally advanced gastric cancer. ClinicalTrials.gov Identifier: NCT01609309.

Potential survival benefits of open over laparoscopic radical gastrectomy for gastric cancer patients beyond three years after surgery: result from multicenter in-depth analysis based on propensity matching

BackgroundThe oncologic efficacy of laparoscopic versus open surgery for advanced distal gastric cancer (ADGC) beyond 3 years after surgery remain obscure.MethodsA total of 1256 patients with ADGC at two teaching institutions in China from April 2007 to December 2014 were enrolled. The general data of the two groups were identified to enable rigorous estimation of propensity scores. Restricted mean survival time (RMST) and Landmark analysis was used to compare survival.ResultsAfter matching 461 patients each in the open distal gastrectomy (ODG) and laparoscopic distal gastrectomy (LDG) groups, they were included into analysis. The 3- and 5-year overall survival (OS) and disease-free survival were comparable in two groups. RMST-stratified analysis showed that the 3-year RMST of ODG group was similar to that of LDG group in patients with cT4a (− 1.38 years, p = 0.163) or with cT4a and tumor size > 5 cm, whereas the 5-year RMST had significant differences between groups in cT4a patients(− 8.36 years, P = 0.005) or cT4a and tumor size > 5 cm patients(4.67 years, P = 0.042). In patients with cT4a and tumors > 5 cm, the number of peritoneal recurrences was significantly fewer in the ODG group than in the LDG group (4 vs. 17, P = 0.033), and the peritoneal recurrence time and multiple-site recurrence time were both later in the ODG group.ConclusionBy reducing recurrence, ODG achieves a better survival for GC patients with serous infiltration and tumors larger than 5 cm beyond 3 years after surgery. The present findings can serve as a reference for surgical options and the setting of follow-up time point for clinical studies.

Efficacy of minimally invasive distal gastrectomy for elderly patients with clinical stage I/IIA gastric cancer: a propensity-score matched analysis.

Phase III trials have shown the non-inferiority of minimally invasive distal gastrectomy (MIDG) comparison with open distal gastrectomy (ODG) in patients with gastric cancer; however, it remains unclear whether MIDG is also effective in the elderly. This study aimed to clarify the efficacy of MIDG in elderly gastric cancer patients. This study included 316 patients older than 75years with clinical stage I/IIA gastric cancer who underwent distal gastrectomy from August 2008 to December 2016 at the Shizuoka Cancer Centre. The long-term outcomes between MIDG and ODG were compared after propensity score matching. After propensity score matching, there were 97 patients each in the MIDG and ODG groups, with an improved balance of confounding factors between the two groups. MIDG was associated with significantly longer operative time and a lower level of blood loss than ODG. The incidence of complications was comparable between the two groups. Survival outcomes were better in the MIDG group than in the ODG group (overall survival; P = 0.034, relapse-free survival; P = 0.027). In the multivariable analysis, ODG [hazard ratio (HR) 1.971, P = 0.046], being 80years or older (HR 2.285, P = 0.018), male sex (HR 2.428, 95% P = 0.024), and poor physical status (HR 2.324, P = 0.022) were identified as independent prognostic factors for overall survival. We found that MIDG showed better efficacy than ODG in elderly gastric cancer patients. MIDG is an acceptable option for elderly patients.

Laparoscopic Versus Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Update from the Class-01 Randomized Controlled Trial

BACKGROUND: It is not clear whether laparoscopic and open distal gastrectomy produce similar outcomes in patients with locally advanced gastric cancer. Data from a multicenter, randomized, controlled trial (CLASS-01) showed that laparoscopic distal gastrectomy did not result in inferior disease-free survival at 3 years compared with open distal gastrectomy. Here, we present 5-year overall survival data from this trial. METHODS: From September 2012 through December 2014, we randomly assigned 1056 patients with clinical stage T2, T3, or T4a gastric cancer (without bulky nodes or distant metastases) to undergo either laparoscopic distal gastrectomy or open distal gastrectomy with D2 lymphadenectomy in a 1:1 ratio. We compared 5-year overall survival between groups in the intent to treat population. RESULTS: We analyzed data from 1039 patients who received curative therapy. At 5 years, the overall survival rates were 72.6% in the laparoscopic distal gastrectomy group and 76.3% in the open distal gastrectomy group (log-rank P =0.19; hazard ratio [HR], 1.17; 95% CI, 0.93–1.48; P =0.187). After we compared for competing risk events, gastric cancer-related deaths (HR, 1.14; 95% CI, 0.87–1.49; P =0.34) and deaths from other causes (HR, 1.23; 95% CI, 0.74–2.05; P =0.42) did not differ significantly between groups. Overall rates of survival did not differ significantly between groups with each tumor stage. CONCLUSIONS: Laparoscopic distal gastrectomy with D2 lymphadenectomy results in similar 5-year overall survival compared to open distal gastrectomy in patients with locally advanced gastric cancer by experienced surgeons in high-volume specialized institutions. TRIAL REGISTRATION: ClinicalTrials.gov. number, NCT01609309 FUNDING STATEMENT: This work was supported by the National Natural Science of China, Guangdong Provincial Key Laboratory of Precision Medicine for Gastrointestinal Tumor, the Key Clinical Specialty Discipline Construction Program from the National Health and Family Planning Commission of China, and the Program of Global Medical Affairs Department of Johnson & Johnson Medical Ltd. DECLARATION OF INTERESTS: None. ETHICS APPROVAL STATEMENT: Each participating center obtained institutional review board approval, according to local regulations. Patients provided written informed consent.

159P Open surgery can improve the 3-year postoperative survival in some patients with advanced gastric cancer compared with laparoscopic surgery: A multicenter, propensity score matching, in-depth analysis

The impact of time on the efficacy of advanced distal gastric cancer (ADGC) remains unclear. At 3 years postoperatively, the efficacy of oncologic surgery for ADGC needs to be confirmed. A total of 1256 patients with ADGC at two teaching institutions in China from April 2007 to December 2014 were enrolled. The general data of the two groups were matched using propensity scores. Restricted mean survival time (RMST) was used to compare survival. After matching, 461 patients each in the open distal gastrectomy (ODG) and laparoscopic distal gastrectomy (LDG) groups were analyzed. The 3- and 5-year overall survival (OS) and disease-free survival in ODG group were comparable to those in LDG group. RMST-stratified analysis showed that the 3-year RMST of ODG group was similar to that of LDG group (-1.38 years, P=0.163) in cT4a patients, whereas the 5-year RMST had significant differences between groups (-8.36 years, P=0.005). In further stratified analysis, when patients with cT4a and tumor was >5 cm, the 3-year RMST of ODG group was similar to that of LDG group (0.98 year, P=0.480); however, the 5-year RMST was significantly longer in ODG group (4.67 years, P=0.042). Multivariate regression analysis showed that ODG is a protective factor for 5-year OS in patients with cT4a and tumors >5 cm. Beyond 3 years, ODG can improve the survival of patients with serous infiltration and tumors >5 cm by reducing the risk of recurrence. The present findings can serve as a reference for the preoperative selection of GC surgery options and the setting of follow-up time for clinical studies.

Clinical Outcomes of Laparoscopic Versus Laparotomic Distal Gastrectomy in Gastric Cancer Patients: A Multilevel Analysis Based on a Nationwide Administrative Database in Japan.

The present study compared the short-term outcomes and costs of laparoscopic distal gastrectomy (LDG) with those of open distal gastrectomy (ODG) for gastric cancer using a nationwide administrative database in Japan. Overall, 37,752 patients with gastric cancer who underwent distal gastrectomy at 1074 hospitals in the fiscal year 2012-2013 were evaluated using a diagnosis procedure combination database in Japan. We performed a retrospective analysis via a multilevel analysis (MLA) of the short-term surgical results and costs of the LDG and ODG groups. The models included the age, sex, comorbid complications, smoking, body mass index (BMI), activity of daily living (ADL), stage, and the number of cases of gastrectomy per facility for adjustment. The in-hospital mortality relative to the hospital volume was also compared. The LDG group required postoperative blood transfusion less frequently and had fewer postoperative complications, shorter hospitalization, and lower operative mortality than the ODG group. While this stage did not correlate with the in-hospital mortality, the surgical method, age, sex, ADL, BMI, comorbidity, and yearly volume showed a correlation. A significant association in the in-hospital mortality was observed between low- and very-high-volume hospitals. In this large nationwide cohort of patients with gastric cancer using an MLA, LDG was shown to be safer with lower mortality and postoperative complication rates than ODG.

Survival outcomes after laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection for clinical stage IA or IB gastric cancer (JCOG0912): a multicentre, non-inferiority, phase 3 randomised controlled trial

Laparoscopy-assisted distal gastrectomy (LADG) is increasingly being used as an alternative to open distal gastrectomy (ODG) for gastric cancer treatment. Retrospective studies have shown equivalent survival with the two procedures, but these studies are limited by selection bias because LADG is more technically difficult than ODG. We aimed to evaluate whether LADG was non-inferior to ODG in terms of long-term survival outcomes. We did an open-label, multicentre, non-inferiority, phase 3 randomised controlled trial at 33 institutions in Japan. Patients aged 20-80 years with histologically confirmed gastric adenocarcinoma (T1N0, T1N1, or T2[MP]N0), clinical stage I, in the middle or lower third of the stomach, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with a body-mass index of less than 30 kg/m2, were randomly assigned (1:1) to receive ODG or LADG. Randomisation was done by telephone, fax, or with a web-based system in the Japan Clinical Oncology Group Data Center; a minimisation method with a random component was used to adjust for institution and clinical stage (IA or IB). Only study-accredited surgeons performed ODG and LADG. The primary endpoint was relapse-free survival and was analysed according to the intention-to-treat principle. The non-inferiority margin (LADG vs ODG) was set at a hazard ratio (HR) of 1·54. The trial was registered with the UMIN Clinical Trials Registry, UMIN000003319. Between March 15, 2010, and Nov 29, 2013, 921 patients were enrolled and randomly assigned to receive ODG (n=459) or LADG (n=462). 912 (99%) participants had the assigned surgery. 5-year relapse-free survival was 94·0% (95% CI 91·4-95·9) in the ODG group and 95·1% (92·7-96·8) in the LADG group. LADG was non-inferior to ODG for relapse-free survival (HR 0·84 [90% CI 0·56-1·27]), p=0·0075). The most common grade 3 or 4 adverse event was bowel obstruction, occurring in 11 (2%) of 455 patients in the ODG group and five (1%) of 457 patients in the LADG group. There were no treatment-related deaths. This trial supports the non-inferiority of LADG compared with ODG for clinical stage I gastric cancer relapse-free survival, suggesting that LADG should be considered a standard treatment option when performed by experienced surgeons. Japan National Cancer Center, Ministry of Health, Labour and Welfare of Japan, Japan Agency for Medical Research and Development.

Laparoscopy Assisted Distal Gastrectomy Versus Open Distal Gastrectomy for Patients with Gastric Cancer in A Middle Resources Country

Background:Laparoscopic surgery with a small laparotomy has several advantages over conventional open surgery, including less invasiveness, less pain, earlier recovery, and better cosmoses. The aim of this study was to compare technical feasibility and early clinical outcomes of laparoscopy-assisted distal gastrectomy in comparison with open distal gastrectomy for gastric cancer in a developing country. Patients and methods :In this retrospective study, patients with distal gastric cancer were divided into two groups (a) patients underwent laparoscopy assisted distal gastrectomy (LADG) (21 patients) and (b) open distal gastrectomy (ODG) (21 patients). For the postoperative pathologic results, the tumor-nodal-metastasis (TNM) stage, grade of tumor differentiation, distal and proximal margins, the number of harvested lymph nodes were evaluated. Staging was done according to the 7th edition of the UICC tumor, node, and metastasis (TNM) classification. D1/D2 lymphadenectomy with curative R0 intention was attempted in all cases. Perioperative mortality and morbidity were assessed. Results:The time to initiate oral intake, and postoperative hospital stay were significantly shorter in the LADG group than in the ODG group (P &lt; 0.001). The operative time in the LADG group was significantly less than that of the ODG group (P = 0.05). Blood loss and blood transfusion frequency were significantly lower (P &lt; 0.0001) in the LADG group in comparison to ODG group. Conclusion:Laparoscopic-assisted distal gastrectomy for distal gastric cancer could be safe and feasible technique alternative to open gastrectomy in a middle income country, with at least similar short term surgical and oncological results. However, laparoscopic gastric surgery is in need to adequate training and technical support especially in D2 lymphadenectomy.

Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer

Laparoscopic distal gastrectomy is accepted as a more effective approach to conventional open distal gastrectomy for early-stage gastric cancer. However, efficacy for locally advanced gastric cancer remains uncertain. To compare 3-year disease-free survival for patients with locally advanced gastric cancer after laparoscopic distal gastrectomy or open distal gastrectomy. The study was a noninferiority, open-label, randomized clinical trial at 14 centers in China. A total of 1056 eligible patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 2012 to December 2014. Final follow-up was on December 31, 2017. Participants were randomized in a 1:1 ratio after stratification by site, age, cancer stage, and histology to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy. The primary end point was 3-year disease-free survival with a noninferiority margin of -10% to compare laparoscopic distal gastrectomy with open distal gastrectomy. Secondary end points of 3-year overall survival and recurrence patterns were tested for superiority. Among 1056 patients, 1039 (98.4%; mean age, 56.2 years; 313 [30.1%] women) had surgery (laparoscopic distal gastrectomy [n=519] vs open distal gastrectomy [n=520]), and 999 (94.6%) completed the study. Three-year disease-free survival rate was 76.5% in the laparoscopic distal gastrectomy group and 77.8% in the open distal gastrectomy group, absolute difference of -1.3% and a 1-sided 97.5% CI of -6.5% to ∞, not crossing the prespecified noninferiority margin. Three-year overall survival rate (laparoscopic distal gastrectomy vs open distal gastrectomy: 83.1% vs 85.2%; adjusted hazard ratio, 1.19; 95% CI, 0.87 to 1.64; P = .28) and cumulative incidence of recurrence over the 3-year period (laparoscopic distal gastrectomy vs open distal gastrectomy: 18.8% vs 16.5%; subhazard ratio, 1.15; 95% CI, 0.86 to 1.54; P = .35) did not significantly differ between laparoscopic distal gastrectomy and open distal gastrectomy groups. Among patients with a preoperative clinical stage indicating locally advanced gastric cancer, laparoscopic distal gastrectomy, compared with open distal gastrectomy, did not result in inferior disease-free survival at 3 years. ClinicalTrials.gov Identifier: NCT01609309.

Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer

Laparoscopic distal gastrectomy is gaining popularity over open distal gastrectomy for gastric cancer because of better early postoperative outcomes. However, to our knowledge, no studies have proved whether laparoscopic distal gastrectomy is oncologically equivalent to open distal gastrectomy. To examine whether the long-term survival among patients with stage I gastric cancer undergoing laparoscopic distal gastrectomy is noninferior to that among patients undergoing open distal gastrectomy. The Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group, which includes 15 surgeons from 13 institutes, conducted a phase 3, multicenter, open-label, noninferiority, prospective randomized clinical trial (KLASS-01) of patients with histologically proven, preoperative clinical stage I gastric adenocarcinoma from January 5, 2006, to August 23, 2010. Survival and recurrence status of the patients was determined in December 2016. Patients were randomly assigned (1:1) to laparoscopic distal gastrectomy (n = 705) or open distal gastrectomy (n = 711). Of these patients, 85 received a surgical approach opposite the one to which they were randomized (63 randomized to the open surgery group and 22 to the laparoscopic group). Difference in 5-year overall survival between the laparoscopic and open distal gastrectomy groups. The noninferiority margin was prespecified as -5% (corresponding hazard ratio of 1.54), with an assumed survival of 90% after 5 years in the open surgery group. Among the 1416 patients (mean [SD] age, 57.3 [11.1] years; 940 [66.4%] male) included in the study, the 5-year overall survival rates were 94.2% in the laparoscopic group and 93.3% in the open surgery group (log-rank P = .64). Intention-to-treat analysis confirmed the noninferiority of the laparoscopic approach compared with the open approach (difference, 0.9 percentage points; 1-sided 97.5% CI, -1.6 to infinity). The 5-year cancer-specific survival rates were similar between the 2 groups (97.1% in the laparoscopic group and 97.2% in the open surgery group, log-rank P = .91; difference, -0.03 percentage points; 1-sided 97.5% CI, -1.8 to infinity). Per-protocol analysis results were consistent with the intention-to-treat results for overall and cancer-specific survival rates. The KLASS-01 trial revealed similar overall and cancer-specific survival rates between patients receiving laparoscopic and open distal gastrectomy. Laparoscopic distal gastrectomy is an oncologically safe alternative to open surgery for stage I gastric cancer. ClinicalTrials.gov identifier: NCT00452751.

Oncologic outcomes after laparoscopic and open distal gastrectomy for advanced gastric cancer: A propensity score matching analysis.

135 Background: The aim of this study is to investigate the oncologic outcomes as well as short-term outcomes of laparoscopic distal gastrectomy compared with open distal gastrectomy for advanced gastric cancer using propensity-score matching analysis. Methods: A total of 384 patients underwent distal gastrectomy for advanced gastric cancer from July 2006 to November 2016. Data on short- and long-term outcomes were collected prospectively and reviewed. Propensity-score matching was applied at a ratio of 1:1 comparing the laparoscopic distal gastrectomy (LDG) group and open distal gastrectomy (ODG) groups. Results: The LDG group showed longer operative time than the ODG group. However, resumption of diet and length of hospital stay were shorter in the LDG group than in the ODG group (4.7 vs. 5.6 days, p= 0.049 and 9.6 vs. 11.5 days, p= 0.035, respectively).The extent of lymph node dissection in the LDG group was more limited than in the ODG group ( p= 0.002), although there was no difference in the number of retrieved lymph nodes between the two groups. The 3-year overall survival rates were 98% and 86.9% ( p= 0.018), whereas the 3-year recurrence-free survival were 86.3% and 75.3%, p= 0.259) in the LDG and the ODG groups. Conclusions: Laparoscopic distal gastrectomy is safe and feasible for advanced gastric cancer in terms of earlier recovery after surgery and long-term oncologic outcomes.

Oncologic Outcomes after Laparoscopic and Open Distal Gastrectomy for Advanced Gastric Cancer: Propensity Score Matching Analysis.

PurposeThis study aimed to compare the oncologic and short-term outcomes of laparoscopic distal gastrectomy (LDG) and open distal gastrectomy (ODG) for advanced gastric cancer (AGC).Materials and MethodsFrom July 2006 to November 2016, 384 patients underwent distal gastrectomy for AGC. Data on short- and long-term outcomes were prospectively collected and reviewed. Propensity score matching was applied at a ratio of 1:1 to compare the LDG and ODG groups.ResultsThe operative times were longer for the LDG group than for the ODG group. However, the time to resumption of diet and the length of hospital stay were shorter in the LDG group than in the ODG group (4.7 vs. 5.6 days, P=0.049 and 9.6 vs. 11.5 days, P=0.035, respectively). The extent of lymph node dissection in the LDG group was more limited than in the ODG group (P=0.002), although there was no difference in the number of retrieved lymph nodes between the 2 groups. The 3-year overall survival rates were 98% and 86.9% (P=0.018), and the 3-year recurrence-free survival rates were 86.3% and 75.3% (P=0.259), respectively, in the LDG and ODG groups.ConclusionsLDG is safe and feasible for AGC, with earlier recovery after surgery and long-term oncologic outcomes comparable to those of ODG.

Comparison of Laparoscopic Distal Gastrectomy With Open Distal Gastrectomy for Patients With Advanced Gastric Cancer: A Single-Center Analysis From a Community Hospital

Objective: This study is aimed to investigate the safety and efficacy of laparoscopic distal gastrectomy (LDG) at the community hospital. Summary of Background Data: Although various clinical trials have shown that laparoscopic distal gastrectomy was feasible in patients with early gastric cancer, its safety and efficacy for patients with advanced gastric cancer need to be elucidated. Methods: Patients with pathological Stage IB-III gastric cancer who underwent open distal gastrectomy (ODG) or LDG with D1+ or more extended lymph node (LN) dissection between 2007 and 2014 were eligible for this retrospective study. Patient characteristics, clinicopathologic factors, and post-treatment recurrence were recorded. To evaluate the safety of the surgery, surgical outcomes and postoperative complication were investigated. Results: 638 patients underwent gastrectomy for gastric cancer, with 67 patients included in ODG group and 61 included in LDG group. Patients in the ODG group showed significantly more progressive disease than those in the LDG group. Postoperative infectious complications, [≥Clavien-Dindo (C-D) classification grade III] occurred 6% in all patients, and there was no significant difference between groups. Hospital stay (median, range) was (9, 6–45) in ODG and (7, 5–58) in LDG, with significantly shorter stays in the LDG group (&amp;lt;0.001). Conclusions: LDG could be safely performed for advanced gastric cancer in a community hospital. However, long-term outcomes, including types of postoperative recurrence, need further evaluation.