Short-Term Outcomes Analysis Comparing Open, Laparoscopic, Laparoscopic-Assisted, and Robotic Distal Gastrectomy for Locally Advanced Gastric Cancer: A Randomized Trials Network Analysis.

BACKGROUND: Minimally invasive surgery for the treatment of locally advanced gastric cancer (AGC) is debated. The aim of this study was to execute a comprehensive assessment of principal surgical treatments for resectable distal gastric cancer. METHODS: Systematic review and randomized controlled trials (RCTs) network meta-analysis. Open (Op-DG), laparoscopic-assisted (LapAs-DG), totally laparoscopic (Lap-DG), and robotic distal gastrectomy (Rob-DG) were compared. Pooled effect-size measures were the risk ratio (RR), the weighted mean difference (WMD), and the 95% credible intervals (CrIs). RESULTS: Ten RCTs (3823 patients) were included. Overall, 1012 (26.5%) underwent Lap-DG, 902 (23.6%) LapAs-DG, 1768 (46.2%) Op-DG, and 141 (3.7%) Rob-DG. Anastomotic leak, severe complications (Clavien-Dindo > 3), and in-hospital mortality were comparable. No differences were observed for reoperation rate, pulmonary complications, postoperative bleeding requiring transfusion, surgical-site infection, cardiovascular complications, number of harvested lymph nodes, and tumor-free resection margins. Compared to Op-DG, Lap-DG and LapAs-DG showed a significantly reduced intraoperative blood loss with a trend toward shorter time to first flatus and reduced length of stay. CONCLUSIONS: LapAs-DG, Lap-DG, and Rob-DG performed in referral centers by dedicated surgeons have comparable short-term outcomes to Op-DG for locally AGC.

Laparoscopic vs. open distal gastrectomy for locally advanced gastric cancer: A systematic review and meta-analysis of randomized controlled trials.

Objective: The aim of this systematic review and meta-analysis is to compare the short- and long-term outcomes of laparoscopic distal gastrectomy (LDG) with those of open distal gastrectomy (ODG) for patients with advanced gastric cancer (AGC) who exclusively underwent distal gastrectomy and D2 lymphadenectomy in randomized controlled trials (RCTs). Background: Data in published meta-analyses that included different gastrectomy types and mixed tumor stages prevented an accurate comparison between LDG and ODG. Recently, several RCTs that compared LDG with ODG included AGC patients specifically for distal gastrectomy, with D2 lymphadenectomy being reported and updated with the long-term outcomes. Methods: PubMed, Embase, and Cochrane databases were searched to identify RCTs for comparing LDG with ODG for advanced distal gastric cancer. Short-term surgical outcomes and mortality, morbidity, and long-term survival were compared. The Cochrane tool and GRADE approach were used for evaluating the quality of evidence (Prospero registration ID: CRD42022301155). Results: Five RCTs consisting of a total of 2,746 patients were included. Meta-analyses showed no significant differences in terms of intraoperative complications, overall morbidity, severe postoperative complications, R0 resection, D2 lymphadenectomy, recurrence, 3-year disease-free survival, intraoperative blood transfusion, time to first liquid diet, time to first ambulation, distal margin, reoperation, mortality, or readmission between LDG and ODG. Operative times were significantly longer for LDG [weighted mean difference (WMD) 49.2 min, p < 0.05], whereas harvested lymph nodes, intraoperative blood loss, postoperative hospital stay, time to first flatus, and proximal margin were lower for LDG (WMD -1.3, p < 0.05; WMD -33.6 mL, p < 0.05; WMD -0.7 day, p < 0.05; WMD -0.2 day, p < 0.05; WMD -0.4 mm, p < 0.05). Intra-abdominal fluid collection and bleeding were found to be less after LDG. Certainty of evidence ranged from moderate to very low. Conclusions: Data from five RCTs suggest that LDG with D2 lymphadenectomy for AGC has similar short-term surgical outcomes and long-term survival to ODG when performed by experienced surgeons in hospitals contending with high patient volumes. It can be concluded that RCTs should highlight the potential advantages of LDG for AGC. Systematic Review Registration: PROSPERO, registration number CRD42022301155.

Late complication after gastrectomy for clinical stage I cancer: supplementary analysis of JCOG0912.

BACKGROUND: Late complications following gastric cancer surgery, including postgastrectomy syndromes, are complex problems requiring a solution. Reported risk factors for developing late complications include surgery-related factors, such as the surgical approach and the extent of resection and reconstruction. However, this has not been assessed in a prospective study with a large sample size. Therefore, this study aimed to evaluate associations between surgery-related factors and the development of late complications. Data from the JCOG0912 trial were used. It compared laparoscopy-assisted distal gastrectomy (LADG) to open distal gastrectomy (ODG) in clinical stage I gastric cancer patients. METHODS: This study included 881/921 patients enrolled in the JCOG0912 trial. The incidence of late complications was compared between the ODG and the LADG arms. In addition, associations between surgery-related factors and the development of late complications were assessed by multivariable analyses using the proportional odds model to identify relevant risk factors. RESULTS: There was no difference in the type or number of patients with late complications between the LADG and the ODG arms. The multivariable analysis for each late complication revealed that the Billroth-I reconstruction (vs. R-en-Y or Billroth-II) had a lower risk of cholecystitis [odds ratio (OR) 0.187, 95% confidence interval (CI) 0.039-0.905, P = 0.037] or ileus (OR 0.116, 95%CI 0.033-0.406, P < 0.001), and pylorus-preserving gastrectomy (vs. R-en-Y or Billroth-II) had a higher risk of reflux esophagitis (OR 3.348, 95% CI 1.371-8.176, P = 0.008). The surgical approach was not a risk factor for any late complications. CONCLUSION: Differences in surgical approaches did not constitute a risk for developing late complications after gastrectomy. Billroth-I reconstruction reduced the risk of ileus and cholecystitis, but pylorus-preserving gastrectomy carried a risk for reflux esophagitis.

Comparison of estimated treatment effects between randomized controlled trials, case-matched, and cohort studies on laparoscopic versus open distal gastrectomy for advanced gastric cancer: a systematic review and meta-analysis.

PURPOSE: In actual surgical research, case-matched studies are frequently conducted as an alternative to randomized controlled trials (RCTs). However, it is still unclear what differences there are between RCTs and case-matched studies in upper gastrointestinal surgery, and clarifying them is a very important clinical issue. Thus, the purpose of this study was to investigate estimated treatment effects between RCTs, case-matched studies, and cohort studies regarding laparoscopic distal gastrectomy (LDG) for advanced gastric cancer (AGC). METHODS: We searched the PubMed, Cochrane Central Register of Controlled Trials, and Web of Science databases for studies that compared LDG versus open distal gastrectomy for AGC published from the inception of the databases until July 2021. A meta-analysis was performed using the Review Manager version 5.3 software program from the Cochrane Collaboration, and six short-term outcomes and three long-term outcomes were assessed. RESULTS: Twenty-three studies with 13698 patients were included. There was no difference in estimated treatment effects between RCTs and case-matched studies for all outcomes except for the number of retrieved lymph nodes and postoperative complications. In terms of intraoperative blood loss, postoperative hospital stay, number of retrieved lymph nodes, and recurrence, observational studies tended to overestimate the treatment effects. CONCLUSION: The estimated treatment effects of LDG for AGC in the case-matched study were almost the same as in the RCTs. However, to assess the true magnitude of the treatment effect, the design and actual implementation of the analysis must be critically evaluated.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 versus open distal gastrectomy for advanced gastric cancer: A meta-analysis of randomized controlled trials and high-quality nonrandomized comparative studies.

BACKGROUND: Controversy persists about the effects of laparoscopic distal gastrectomy (LDG) versus open distal gastrectomy (ODG) on short-term surgical outcomes and long-term survival within the field of advanced gastric cancer (AGC). METHODS: Studies published from January 1994 to February 2020 that compare LDG and ODG for AGC were identified. All randomized controlled trials (RCTs) were included. The selection of high-quality nonrandomized comparative studies (NRCTs) was based on a validated tool (Methodological Index for Nonrandomized Studies, MINORS). The short- and long-term outcomes of both procedures were compared. RESULTS: Overall, 30 studies were included in this meta-analysis, which comprised of 8 RCTs and 22 NRCTs involving 16,029 patients (7864 LDGs, 8165 ODGs). The recurrence, 3-year disease-free survival (DFS), 3-year overall survival (OS), and 5-year OS rates for LDG and ODG were comparable. LDG was associated with a lower postoperative complication rate (OR 0.79; P < 0.00001), lower estimated volume of blood loss (WMD -102.21 mL; P < 0.00001), shorter postoperative hospital stay (WMD -1.96 days; P < 0.0001), shorter time to first flatus (WMD -0.54 day; P = 0.0007) and shorter time to first liquid diet (WMD -0.66 day; P = 0.001). The number of lymph nodes retrieved, mortality, intraoperative complications, intraoperative blood transfusion, and time to ambulation were similar. However, LDG was associated with a longer surgical time (WMD 33.57 min; P < 0.00001). CONCLUSIONS: LDG with D2 lymphadenectomy is a safe and effective technique for patients with AGC when performed by experienced surgeons at high-volume specialized centers.

Equivalent feasibility and safety of perioperative care by ERAS in open and laparoscopy-assisted distal gastrectomy for gastric cancer: a single-institution ancillary study using the patient cohort enrolled in the JCOG0912 phase III trial.

BACKGROUND: Laparoscopy-assisted distal gastrectomy (LADG) has an advantage of earlier recovery after surgery due to having lower invasiveness and wound pain than open distal gastrectomy (ODG). However, whether the same enhanced recovery after surgery (ERAS) program for LADG is equally feasible and safe for ODG remains unclear. METHODS: We retrospectively extracted the clinical data of the patients enrolled in JCOG0912 from the medical record system of our hospital and compared the treatment process and short-term surgical outcomes between LADG and ODG. Our ERAS program consisted of 13 elements (4 preoperative, 4 intraoperative, and 5 postoperative elements). The morbidity was defined as complications of grade 2 or more. RESULTS: One hundred and sixty-three patients were entered from our hospital and randomized to undergo ODG (82 patients) or LADG (81 patients). The patient's backgrounds, surgical outcomes, and pathological outcomes were similar between the ODG and LADG groups. The rate of completing the clinical pathway was 95.1% in both groups, and the rates of completing each ERAS element were similar. However, the additional use of acetaminophen was significantly more frequent in the ODG group than in the LADG group (18.3% vs. 6.2%, p = 0.03). The median hospital stay after surgery was 9 days in both groups. Morbidity, defined as Clavien-Dindo classification > grade 2, was observed in 6.1% of the ODG group and 11.1% of the LADG group. No mortality occurred in either group. CONCLUSION: This study showed that the regimen of perioperative care performed by the ERAS program for LADG was equally feasible and safe for ODG with additional pain control. Less pain observed in LADG was not so apparent advantage for completion and safety of ERAS care.

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.

BACKGROUND: Although laparoscopic surgery has been recommended as an optional therapy for patients with early gastric cancer, whether patients with locally advanced gastric cancer (AGC) could benefit from laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy remains elusive due to a lack of comprehensive clinical data. To evaluate the efficacy of LADG, we conducted a multi-institutional randomized controlled trial to compare laparoscopy-assisted versus open distal gastrectomy (ODG) for AGC in North China. METHODS: In this RCT, after patients were enrolled according to the eligibility criteria, they were preoperatively assigned to LADG or ODG arm randomly with a 1:1 allocation ratio. The primary endpoint was the morbidity and mortality within 30 postoperative days to evaluate the surgical safety of LADG. The secondary endpoint was 3-year disease-free survival. This trial was registered at ClinicalTrial.gov as NCT02464215. RESULTS: Between March 2014 and August 2017, a total of 446 patients with cT2-4aN0-3M0 (AJCC 7th staging system) were enrolled. Of these, 222 patients underwent LADG and 220 patients underwent ODG were included in the modified intention-to-treat analysis. The compliance rate of D2 lymph node dissection was identical between the LADG and ODG arms (99.5%, P = 1.000). No significant difference was observed regarding the overall postoperative complication rate in two groups (LADG 13.1%, ODG 17.7%, P = 0.174). No operation-related death occurred in both arms. CONCLUSIONS: This trial confirmed that LADG performed by credentialed surgeons was safe and feasible for patients with AGC compared with conventional ODG.

Does a laparoscopic approach attenuate the body weight loss and lean body mass loss observed in open distal gastrectomy for gastric cancer? a single-institution exploratory analysis of the JCOG 0912 phase III trial.

BACKGROUND: Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer may prevent the loss of body weight and lean body mass resulting from reduced surgical stress in comparison to open distal gastrectomy (ODG). A multicenter phase III trial conducted by the Japan Clinical Oncology Group (JCOG0912 trial) was performed to confirm the non-inferiority of LADG to ODG for stage I gastric cancer in terms of relapse-free survival. METHODS: This study was performed as a single-institution exploratory analysis using the data of the patients from our hospital who were enrolled in the JCOG0912 phase III trial. Body weight and lean body mass were evaluated using a bioelectrical impedance analyzer within 1 week before and at 1 week, 1 month, and 3 months after surgery. RESULTS: One-hundred six patients were randomized to undergo ODG (54 patients) or LADG (51 patients). Body weight loss at 1 week, 1 month, and 3 months was -3.0%, -4.9%, and -5.4%, respectively, in the ODG group and -2.7%, -4.3%, and -5.7%, respectively, in the LADG group; the differences were not statistically significant (p = 0.330, 0.166, and 0.656, respectively). Lean body mass loss at 1 week, 1 month, and 3 months was -2.8%, -4.1%, and -2.3%, respectively, in the ODG group and -2.7%, -2.9%, and -3.0%, respectively, in the LADG group; the differences were not statistically significant (p = 0.610, 0.413, and 0.925, respectively). CONCLUSIONS: The laparoscopic approach did not attenuate the loss of body weight and lean body mass in comparison to patients who underwent open distal gastrectomy for gastric cancer.

Laparoscopy-assisted versus open distal gastrectomy for gastric cancer in elderly patients: a retrospective comparative study.

BACKGROUND: With the current increased longevity in elderly population, surgeons can expect to operate more frequently on elderly patients with both malignancies and comorbid medical conditions. This study aimed to compare the surgical and early postoperative outcomes of laparoscopy-assisted distal gastrectomy (LADG) with those of open distal gastrectomy (ODG) for gastric cancer in patients 70 years of age or older. METHODS: Retrospective analysis based on a prospectively collected database of elderly patients who underwent laparoscopy-assisted distal gastrectomy or ODG from February 2013 to January 2014. Preoperative patient baseline parameters, surgical and oncological outcomes, postoperative complications and pathologic results were analyzed in this report. RESULTS: Distal gastrectomy was performed for 50 patients with the age of 70 years or older, using laparoscopic surgery for 23 patients (LADG group) and open surgery for 27 patients (ODG group). The mean age of LADG group was 76.6 years and ODG group 80.0 years. The comparison between the two groups revealed statistically similar results regarding age, gender, BMI, ASA class, history of previous surgeries, CCI and pathologic characteristics. The LADG group was characterized by less intraoperative blood loss (LADG group 100 mL vs. ODG group 250 mL, P < 0.001), less narcotic use (LADG group 1 day vs. ODG group 3 days, P < 0.001), faster bowel function recovery (time to first flatus: LADG group 51.6 h vs. ODG group 67.2 h, P < 0.001; days to oral intake: LADG group 6.1 days vs. ODG group 7.9 days, P = 0.002) and shorter postoperative hospital stay (LADG group 12 days vs. ODG group 16 days, P < 0.001). There was no significant difference in postoperative complication rate (overall complication rate: LADG group 21.7 % vs. ODG group 25.9 %, P = 0.730), survival rate (P = 0.719), postoperative recurrence and metastasis rate between the patients who underwent LADG and ODG. CONCLUSIONS: LADG for gastric cancer is feasible, efficacious and safe in elderly patients and may be superior to conventional open resection as regards some surgical outcomes.

Laparoscopy-assisted versus open distal gastrectomy for early gastric cancer: A meta-analysis based on seven randomized controlled trials.

OBJECTIVE: This study aims to answer the superiority of comparing laparoscopy-assisted distal gastrectomy (LADG) with open distal gastrectomy (ODG) in the treatment early gastric cancer (EGC). MATERIAL AND METHODS: A comprehensive search up to May 31, 2014 was conducted on PubMed, Web of science, and the Cochrane Library. All eligible studies comparing LADG versus ODG were included. Data synthesis and statistical analysis were performed using RevMan 5.2 software. RESULTS: Seven randomized controlled trials (RCTs) totaling 390 patients (195 LADG and 195 ODG) were analyzed. Compared to ODG, LADG showed longer operative time (WMD = 79.60; 95%CI = 59.86 to 99.35; P < 0.00001), but was associated with less blood loss (WMD = -108.11; 95%CI = -145.97 to -70.26; P < 0.00001), fewer administered analgesics (WMD = -1.70; 95%CI = -2.19 to -1.22; P < 0.00001), fewer number of harvested lymph node (WMD = -2.77; 95%CI = -4.38 to -1.16; P = 0.0007), lower incidence of postoperative complications (OR = 0.26; 95%CI = 0.13 to 0.54; P = 0.0003), shorter postoperative hospital stay (WMD = -1.0; 95% CI = -1.83 to -0.16; P = 0.02) and earlier passage of flatus (WMD = -0.62; 95% CI = -0.96 to -0.27; P = 0.0005). CONCLUSION: This meta-analysis demonstrated that LADG significantly reduced blood loss, decreased the frequency of analgesic administration, faster recovery, a shorter hospital stay and fewer postoperative complications compared with ODG, though at the price of longer operative times and the number of harvested lymph nodes lesser as compared to ODG.

Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01).

A randomized controlled trial to evaluate the long-term outcomes of laparoscopic distal gastrectomy for gastric cancer is currently ongoing in Korea. Patients with cT1N0M0-cT2aN0M0 (American Joint Committee on Cancer, 6th edition) distal gastric cancer were randomized to receive either laparoscopic or open distal gastrectomy. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 cases each of laparoscopy-assisted distal gastrectomy and open distal gastrectomy and their institutions should have performed more than 80 cases each of both procedures each year. Fifteen surgeons from 12 institutions recruited 1,415 patients. The primary endpoint is overall survival. The secondary endpoints are disease-free survival, morbidity, mortality, quality of life, inflammatory and immune responses, and cost-effectiveness (ClinicalTrials.gov ID: NCT00452751).

Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01) / 대한외과학회지

A randomized controlled trial to evaluate the long-term outcomes of laparoscopic distal gastrectomy for gastric cancer is currently ongoing in Korea. Patients with cT1N0M0-cT2aN0M0 (American Joint Committee on Cancer, 6th edition) distal gastric cancer were randomized to receive either laparoscopic or open distal gastrectomy. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 cases each of laparoscopy-assisted distal gastrectomy and open distal gastrectomy and their institutions should have performed more than 80 cases each of both procedures each year. Fifteen surgeons from 12 institutions recruited 1,415 patients. The primary endpoint is overall survival. The secondary endpoints are disease-free survival, morbidity, mortality, quality of life, inflammatory and immune responses, and cost-effectiveness (ClinicalTrials.gov ID: NCT00452751).

Comparison of the Nutritional Status and the Acute Inflammatory Reaction between Laparoscopy-assisted Distal Gastrectomy and Conventional Open Distal Gastrectomy for Early Gastric Cancer

PURPOSE: Laparoscopy-assisted gastrectomy (LAG) is gaining wider acceptance as a minimally invasive treatment for early gastric cancer, but the safety, efficacy and clinical benefits of this type of surgery are still unclear. The purpose of this study is to compare laparoscopy-assisted gastrectomy (LADG) and conventional open distal gastrectomy (CODG) for early gastric cancer (EGC) according to the changes of the postoperative nutritional status and acute inflammatory reaction. MATERIALS AND METHODS: Eighty seven patients with EGC and who underwent a LADG between March 2006 and May 2009 at Daegu Catholic University Hospital, was enrolled. Over the same period, we enrolled 30 patients who underwent CODG and they were confirmed to have EGC from their pathology. The clinico-pathological features and serologic parameters were evaluated from the medical records and then retrospectively analyzed. RESULTS: There were no differences in the preoperative white blood cell (WBC), C-reactive protein (CRP) level, albumin level, the T4/T8 ratio and the other clinical data between the two groups. The total WBC counts gradually increased and they were significant lower at the 1st and 3rd postoperative days in the LADG group than that in the CODG group (P=0.001 and 0.008, respectively). The postoperative CRP levels were significantly lower at postoperative 5th day in the LADG group (P<0.001). The postoperative albumin and T4/T8 ratio gradually decreased, and the T4/T8 ratio was significantly higher at the 3rd postoperative day in the LADG group compared to that in the CODG group (P=0.003). CONCLUSION: This study demonstrates that the LADG has less of an influence on an acute inflammatory reaction than does CODG. Therefore, it is one of the safe and feasible procedures for the treatment of early gastric cancer.

The Effects of Obesity on Laparoscopy-Assisted Distal Gastrectomy and Conventional Open Gastrectomy in Patients with Early Gastric Cancer

PURPOSE: The aim of this study was to assess the short-term results of conventional open distal gastrectomy (ODG) and laparoscopy-assisted distal gastrectomy (LADG) in obese patients with early gastric cancer. METHODS: This study included 28 consecutive patients who underwent LADG and 33 patients who underwent ODG for early gastric cancer. The patients were divided into two groups: obese (body mass index, BMI> or =25) and non-obese (BMI<25). Patient characteristics, operative details, and postoperative outcomes were analyzed and compared between the two groups. RESULTS: The operation time was longer in LADG patients than in ODG patients. In the LADG group, the high BMI subset required significantly longer operative time than the low BMI subset. The number of retrieved lymph nodes, average perioperative hemoglobin concentration, serum albumin, first flatus, and postoperative WBC count were similar between the two groups. Regarding ODG patients, the mean perioperative decrease in hemoglobin concentration was significantly greater in the high BMI subset. The difference in operative time between the ODG/high BMI subset and the ODG/low BMI subset was not statistically significant. CONCLUSION: Obesity has differing effects on LADG and on ODG, and this should be considered when deciding what procedure to utilize in patients with early gastric cancer. Further research is needed to better elucidate the relationship between obesity and gastrectomy for early gastric cancer.