Prognostic significance of distal subtotal gastrectomy with standard D2 and extended D2 lymphadenectomy for locally advanced gastric cancer.
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ABSTRACT:
SUBMITTER: Zhang CD
PROVIDER: S-EPMC4658555 | biostudies-other | 2015
REPOSITORIES: biostudies-other
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Project description:BackgroundDespite 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/designThis 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.DiscussionThis 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.Trial registrationClinicalTrial.gov, NCT01456598.
| S-EPMC4432816 | biostudies-literature
Project description:BackgroundAlthough radical gastrectomy with D2 lymph node dissection has become the standard surgical approach for locally advanced gastric cancer, patients still have a poor prognosis after operation. Previously, we proposed laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision [D2 + CME]) as an optimized surgical procedure for locally advanced gastric cancer. By dissection along the boundary of the mesogastrium, D2 + CME resected proximal segments of the dorsal mesogastrium completely with less blood loss, and it improved the short-term surgical outcome. However, the oncologic therapeutic effect of D2 + CME has not yet been confirmed.Methods/designA single-center, prospective, parallel-group, randomized controlled trial of laparoscopic distal gastrectomy with D2 + CME versus conventional D2 was conducted for patients with locally advanced gastric cancer at Tongji Hospital, Wuhan, China. In total, 336 patients who met the following eligibly criteria were included and were randomized to receive either the D2 + CME or D2 procedure: (1) pathologically proven adenocarcinoma; (2) 18 to 75 years old; cT2-4, N0-3, M0 at preoperative evaluation; (3) expected curative resection via laparoscopic distal gastrectomy; (4) no history of other cancer, chemotherapy, or radiotherapy; (5) no history of upper abdominal operation; and (6) perioperative American Society of Anesthesiologists class I, II, or III. The primary endpoint is 3 years of disease-free survival. The secondary endpoints are overall survival, recurrence pattern, mortality, morbidity, postoperative recovery course, and other parameters.DiscussionPrevious studies have demonstrated the safety and feasibility of D2 + CME for locally advanced gastric cancer; however, there is still a lack of evidence to support its therapeutic effect. Thus, we performed this randomized trial to investigate whether D2 + CME can improve oncologic outcomes of patients with locally advanced gastric cancer. The findings from this trial may potentially optimize the surgical procedure and may improve the prognosis of patients with locally advanced gastric cancer.Trial registrationClinicalTrials.gov, NCT01978444 . Registered on October 31, 2013.
| S-EPMC6085680 | biostudies-literature
Project description:By overcoming technical difficulties with limited access faced when performing reduced-port surgery for gastric cancer, reduced-port totally robotic gastrectomy (RPRDG) could be a safe alternative to conventional minimally invasive gastrectomy. An initial 100 consecutive cases of RPRDG for gastric cancer were performed from February 2016 to September 2018. Short-term outcomes for RPRDG with those for 261 conventional laparoscopic (CLDG) and for 241 robotic procedures (CRDG) over the same period were compared. Learning curve analysis for RPRDG was conducted to determine whether this procedure could be readily performed despite fewer access. During the first 100 cases of RPRDG, no surgeries were converted to open or laparoscopic surgery, and no additional ports were required. RPRDG showed longer operation time than CLDG (188.4 min vs. 166.2 min, p < 0.001) and similar operation time with CRDG (183.1 min, p = 0.315). The blood loss was 35.4 ml for RPRDG, 85.2 ml for CLDG (p < 0.001), and 41.2 ml for CRDG (p = 0.33). The numbers of retrieved lymph nodes were 50.5 for RPRDG, 43.9 for CLDG (p = 0.003), and 55.0 for CRDG (p = 0.055). Postoperative maximum C-reactive protein levels were 96.8 mg/L for RPRDG, 87.8 mg/L for CLDG (p = 0.454), and 81.9 mg/L for CRDG (p = 0.027). Learning curve analysis indicated that the overall operation time of RPRDG stabilized at 180 min after 21 cases. The incidence of major postoperative complications did not differ among groups. RPRDG for gastric cancer is a feasible and safe alternative to conventional minimally invasive surgery. Notwithstanding, this procedure failed to reduce postoperative inflammatory responses.
| S-EPMC7524794 | biostudies-literature
Project description:BackgroundThe complete mesogastrium excision (CME) based on D2 radical gastrectomy is believed to significantly reduce the local-regional recurrence compared with D2 radical gastrectomy in advanced gastric cancer, and it is widely used in China. This study aimed to explore whether D2 + CME is superior to D2 on surgical outcomes during gastrectomy from Chinese data.MethodsFeasible studies comparing the D2 + CME (D2 + CME group) and D2 (D2 group) published up to March 2020 are searched from electronic databases. The data showing surgical and complication outcomes are extracted to be pooled and analyzed.ResultsFourteen records including 1352 patients were included. The D2 + CME group had a shorter mean operative time (weighted mean difference [WMD] = -16.72 min, 95% confidence interval [CI]: -26.56 to -6.87 min, P < 0.001), lower mean blood loss (WMD = -39.08 mL, 95% CI: -49.94 to -28.21 mL, P < 0.001), higher mean number of retrieved lymph nodes (WMD = 2.13, 95% CI: 0.58-3.67, P = 0.007), shorter time to first flatus (WMD = -0.31 d, 95% CI: -0.53 to - 0.10 d, P = 0.005), and postoperative hospital days (WMD = -1.09, 95% CI: -1.92 to -0.25, P = 0.010) than the D2 group. Subgroup analysis suggested that the advantages from the D2 + CME group were obvious in traditional open radical gastrectomy, proximal gastrectomy, and distal gastrectomy compared with D2 group. The evaluations of post-operative complications showed that the patients who underwent D2 + CME had a lower incidence of post-operative complications than the patients who underwent D2 surgery alone (relative risk [RR] = 0.65, 95% CI: 0.45-0.87, P = 0.003). The D2 radical gastrectomy plus CME improved 3-year overall survival (OS) (RR = 1.16, 95% CI: 1.02-1.32, P = 0.020) and lowered the local recurrence rate (RR = 0.51, 95% CI: 0.28-0.94, P = 0.030). The patients undergoing laparoscopic surgery or total gastrectomy had more significant advantages compared between D2 + CME and D2 groups in 3-year OS.ConclusionThe data from China show that D2 radical gastrectomy plus CME are reliable procedures and safety compared to D2 radical gastrectomy with faster recovery, lower risk, and better prognosis.
| S-EPMC9337254 | biostudies-literature
Project description:Background/aimsTotal gastrectomy (TG) has shown to be superior regarding low risk of recurrence and readmission to distal subtotal gastrectomy (DG) for treatment of distal stomach cancer, but the incidence of postoperative morbidity and mortality in TG cannot be ignored. Therefore, we performed a meta-analysis to compare the effectiveness between TG and DG for distal stomach cancer.MethodologyA search in PubMed, EMBASE, the Cochrane Library, Web of Science, Chinese Biomedical Database through January 2016 was performed. Eligible studies in comparing of TG and DG for distal gastric cancer were included in this meta-analysis. Review Manager 5.2 software from the Cochrane Collaboration was used for the performance of meta-analysis and STATA 12.0 software for meta-regression analysis.ResultsTen retrospective cohort studies and one randomized control trial involving 5447 patients were included. The meta-analysis showed no significant difference of postoperative mortality (RR = 1.48, 95%CI = 0. 90-2.44,p = 0.12), intraoperative blood loss (MD = 24.34, 95%CI = -3.31-51.99, p = 0.08) and length of hospital stay(MD = 0.76, 95%CI:-0.26-1.79, p = 0.15). TG procedure could retrieve more lymph nodes than DG(MD = 4.33, 95% CI = 2.34-6.31, p<0.0001). According to different postoperative complications, we performed subgroup analysis, subgroup analysis revealed that patients in TG group tended to have a higher rate of postoperative intra-abdominal abscess than DG procedure (RR = 3.41, 95% CI = 1.21-9.63,p<0.05). No statistical differences were found in leakage, intestinal obstruction, postoperative bleeding, anastomotic stricture and wound infection between the two groups (p>0.05). We pooled the data together, the accumulated 5-year Overall Survival rates of TG and DG groups were 49.6% (919/1852) vs.55.9%(721/1290) respectively. Meta-analysis revealed a favoring trend to DG procedure and there was a statistical difference between the two groups (RR = 0.91,95% CI = 0.85-0.97,p = 0.006).ConclusionBased on current retrospective evidences, we found that in spite of similar postoperative mortality, TG for distal gastric cancer provided a high risk of five-year Overall Survival rate. DG procedure can be a recommendation for distal gastric cancer, whereas due to lack of high quality RCTs in multicenter and the relatively small sample size of long-term outcomes, further comparative studies are still needed.
| S-EPMC5082689 | biostudies-literature
Project description:The objective of this study is to describe the compliance to D2 lymphadenectomy in laparoscopic gastrectomy. Radical partial or total gastrectomy with modified D2 lymphadenectomy is the standard of care for locally advanced gastric cancer. It is unclear whether compliance to D2 lymphadenectomy in laparoscopy is comparable to that in open surgery. A review of the literature was performed and results are described in a descriptive review. Available randomized trials are mostly performed for early gastric cancer, for which formal D2 lymphadenectomy is usually not required. Most trials report no differences in number of retrieved lymph nodes between open and laparoscopic gastrectomy. Only one trial used adherence to D2 lymphadenectomy as primary outcome parameter, and found no difference between laparoscopic and open gastrectomy. Results from randomized trials in advanced gastric cancer are awaited. In the meantime, the laparoscopic approach can be used in experienced centers.
| S-EPMC6060987 | biostudies-literature
Project description:To conduct a meta-analysis comparing laparoscopic (LGD2) and open D2 gastrectomies (OGD2) for the treatment of advanced gastric cancer (AGC).Randomized controlled trials (RCTs) and non-RCTs comparing LGD2 with OGD2 for AGC treatment, published between 1 January 2000 and 12 January 2013, were identified in the PubMed, Embase, and Cochrane Library databases. Primary endpoints included operative outcomes (operative time, intraoperative blood loss, and conversion rate), postoperative outcomes (postoperative analgesic consumption, time to first ambulation, time to first flatus, time to first oral intake, postoperative hospital stay length, postoperative morbidity, incidence of reoperation, and postoperative mortality), and oncologic outcomes (the number of lymph nodes harvested, tumor recurrence and metastasis, disease-free rates, and overall survival rates). The Cochrane Collaboration tools and the modified Newcastle-Ottawa scale were used to assess the quality and risk of bias of RCTs and non-RCTs in the study. Subgroup analyses were conducted to explore the incidence rate of various postoperative morbidities as well as recurrence and metastasis patterns. A Begg's test was used to evaluate the publication bias.One RCT and 13 non-RCTs totaling 2596 patients were included in the meta-analysis. LGD2 in comparison to OGD2 showed lower intraoperative blood loss [weighted mean difference (WMD) = -137.87 mL, 95%CI: -164.41--111.33; P < 0.01], lower analgesic consumption (WMD = -1.94, 95%CI: -2.50--1.38; P < 0.01), shorter times to first ambulation (WMD = -1.03 d, 95%CI: -1.90--0.16; P < 0.05), flatus (WMD = -0.98 d, 95%CI: -1.30--0.66; P < 0.01), and oral intake (WMD = -0.85 d, 95%CI: -1.67--0.03; P < 0.05), shorter hospitalization (WMD = -3.08 d, 95%CI: -4.38--1.78; P < 0.01), and lower postoperative morbidity (odds ratio = 0.78, 95%CI: 0.61-0.99; P < 0.05). No significant differences were observed between LGD2 and OGD2 for the following criteria: reoperation incidence, postoperative mortality, number of harvested lymph nodes, tumor recurrence/metastasis, or three- or five-year disease-free and overall survival rates. However, LGD2 had longer operative times (WMD = 57.06 min, 95%CI: 41.87-72.25; P < 0.01).Although a technically demanding and time-consuming procedure, LGD2 may be safe and effective, and offer some advantages over OGD2 for treatment of locally AGC.
| S-EPMC4248223 | biostudies-other
Project description:BackgroundNeoadjuvant chemotherapy followed by gastrectomy with D2 lymphadenectomy is commonly used for patients with locally advanced gastric adenocarcinoma. The eighth AJCC ypTNM staging system was validated based on patients undergoing more limited lymphadenectomy (less than D2). The aim of this study was to develop a system for accurate staging of patients with locally advanced gastric adenocarcinoma who receive neoadjuvant chemotherapy followed by gastrectomy with D2 lymphadenectomy.MethodsA modified system of ypTNM was developed, based on overall survival (OS) of patients receiving neoadjuvant chemotherapy followed by gastrectomy with D2 lymphadenectomy at Memorial Sloan Kettering Cancer Center, and validated using data from an international cohort of patients who had similar treatment.ResultsOf 325 patients in the derivation cohort, 33 (10·2 per cent) had ypT0 N0/+ tumours, which are not classifiable under the AJCC system. The 5-year OS rate for modified ypTNM stages I, II, IIIA and IIIB was 89, 71, 42·3 and 10 per cent respectively, compared with 82, 65·2 and 24·1 for AJCC stages I, II and III respectively. The concordance index (0·730 versus 0·709), estimated area under the curve (0·765 versus 0·740) and time-dependent receiver operating characteristic (ROC) curve throughout the observation period were all superior for modified ypTNM staging. For the validation cohort of 186 patients, the modified system was again better at separating patients into prognostic groups for OS.ConclusionThe modified ypTNM staging system improves the accuracy of OS prediction for patients treated with neoadjuvant chemotherapy followed by gastrectomy with D2 lymphadenectomy.
| S-EPMC8194033 | biostudies-literature
Project description:BackgroundThe effectiveness of laparoscopic total gastrectomy with D2 lymphadenectomy (LTGD2) remains controversial. This meta-analysis compares surgical and survival outcomes of LTGD2 and open total gastrectomy with D2 lymphadenectomy (OTGD2) for gastric cancer.MethodsControlled studies comparing LTGD2 and OTGD2 published before November 2021 were retrieved via database searches. We compared intraoperative outcomes, pathological data, postoperative outcomes, 5-year disease-free survival (DFS), and overall survival (OS).Results17 studies were included, containing 4742 patients. Compared with OTGD2, the LTGD2 group had less blood loss (mean difference [MD] = - 122.48; 95% CI: - 187.60, - 57.37; P = 0.0002), fewer analgesic medication (MD = -2.48; 95% CI: - 2.69, - 2.27; P < 0.00001), earlier first flatus (MD = - 1.03; 95% CI: - 1.80, - 0.26; P = 0.009), earlier initial food intake (MD = - 0.89; 95% CI: - 1.09, - 0.68; P < 0.00001) and shorter hospital stay (MD = - 3.24; 95% CI: - 3.75, - 2.73; P < 0.00001). The LTGD2 group had lower postoperative total complication ratio (OR = 0.76; 95% CI: 0.62, 0.92; P = 0.006), incision (OR = 0.50; 95% CI:0.31, 0.79; P = 0.003) and pulmonary (OR = 0.57; 95% CI: 0.34, 0.96; P = 0.03) complication rates, but similar rates of other complications and mortality. Total number of dissected lymph nodes were similar, but the number of No. 10 dissected nodes was less with LTGD2 (MD = - 0.31; 95% CI: - 0.46, - 0.16; P < 0.0001). There was no difference in 5-year OS (P = 0.19) and DFS (P = 0.34) between LTGD2 and OTGD2 groups.ConclusionsLTGD2 produces small trauma, fast postoperative recovery and small length of hospital stays than OTGD2, and had similar long-term clinical efficacy as OTGD2. However, these results still need further high-quality prospective randomized controlled trials confirmation.
| S-EPMC9290297 | biostudies-literature
Project description:There has still not been a consensus in aspects of survival benefit and safety on No.12a lymph nodes (LNs) dissection for gastric cancer patients. This study was aimed to evaluate this issue for patients with distal or total gastrectomy. Patients were retrospectively divided into 12aD+ group (with No.12a dissection) and 12aD-group (without No.12a dissection). Clinicopathologic characteristics, survival rate, morbidity and mortality were compared. There were 670 patients in 12aD+ group, while 567 in 12aD-group. The baselines between the two groups were comparable. The No.12a LNs metastasis ratio was 11.6% and higher in lower third tumor. The metastasis of No.5 LNs, N stage and M stage were correlated to metastasis of No.12a LNs. There was no difference in morbidity nor mortality between the two groups. The 5-year overall survival rates (5-y OS) were 59.6% and 55.1% in 12aD+ group and 12aD-group respectively (P = 0.075). The 5-y OS of patients with negative and positive No.12a LNs were 62.3% and 24.1%. The survival of stage III patients with No.12a positive was better than that of stage IV patients. The 5-y OS were better in 12aD+ group for patients with ages more than 60, lower third tumor, distal gastrectomy, N3 status, or III stages compared with 12aD-group. No.12a lymphadenectomy was independently better prognostic factors for stage III patients. No.12a LNs metastasis should not be considered as distant metastasis. No.12a lymphadenectomy can be performed safely and should be indicated for potentially curable progressive stage tumors requiring distal gastrectomy and might be reserved in patients with stage I or II, or upper third tumor.
| S-EPMC4951326 | biostudies-literature