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Complete mesogastric excision for locally advanced gastric cancer: short-term outcomes of a randomized clinical trial.

ABSTRACT: Implementation of complete mesogastric excision in gastric cancer surgery, named D2 lymphadenectomy plus complete mesogastric excision (D2+CME), has recently been proposed as an optimal procedure. However, the safety and efficacy of D2+CME remain uncertain. In this randomized controlled trial, patients receiving D2+CME exhibit less intraoperative blood loss, more lymph node harvesting, and earlier postoperative flatus than patients receiving conventional D2 radical surgery. Univariate Cox regression analysis reveals that the risk ratio for postoperative flatus in D2+CME group is 1.247 (p = 0.044). Overall postoperative complications are comparable between the two groups, but complications are significantly less severe in the D2+CME group than the D2 group (Clavien-Dindo classification grade ≥ IIIa: 4 D2+CME patients [11.8%] versus 9 D2 patients [33.3%]; p = 0.041). In conclusion, our work shows that D2+CME is associated with better short-term outcomes and surgical safety than conventional D2 dissection for patients with advanced gastric cancer.

SUBMITTER: Xie D

PROVIDER: S-EPMC7974547 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Complete mesogastric excision for locally advanced gastric cancer: short-term outcomes of a randomized clinical trial.

Xie Daxing D Shen Jie J Liu Liang L Cao Beibei B Wang Yatao Y Qin Jichao J Wu Jianhong J Yan Qun Q Hu Yuanlong Y Yang Chuanyong C Cao Zhixin Z Hu Junbo J Yin Ping P Gong Jianping J

Cell reports. Medicine 20210316 3

Implementation of complete mesogastric excision in gastric cancer surgery, named D2 lymphadenectomy plus complete mesogastric excision (D2+CME), has recently been proposed as an optimal procedure. However, the safety and efficacy of D2+CME remain uncertain. In this randomized controlled trial, patients receiving D2+CME exhibit less intraoperative blood loss, more lymph node harvesting, and earlier postoperative flatus than patients receiving conventional D2 radical surgery. Univariate Cox regres ...[more]

PMID: 33763656

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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.

Project description:BackgroundThe technical challenges and safety issues involving laparoscopic D2 lymphadenectomy plus complete mesogastric excision (D2 + CME) for high body mass index (BMI) patients are still unknown. This study was conducted to compare the short-term outcomes of laparoscopic D2 + CME and D2 lymphadenectomy in distal gastric cancer patients of different BMI status.MethodsWe retrospectively analyzed the data of patients with gastric cancer who underwent laparoscopic-assisted distal gastrectomy (LADG) at our center between 2019 June and 2023 September. Patients who underwent traditional laparoscopic D2 lymphadenectomy were divided into the D2 group, while patients undergoing laparoscopic D2 + CME were divided into the D2 + CME group. In each group, patients were further subdivided based on their BMI into the high BMI group (H-BMI, BMI ≥ 25) and normal BMI (N-BMI, BMI<25) group. A comparison was made between the characteristics of patients and their short-term outcomes in the two subgroups, respectively. Propensity score matching (PSM) at 1:1 ratio was performed to further assess the short-term outcomes of patients with high BMI in two groups.ResultsAII the qualified patients were divided into the D2 group (n = 329) and D2 + CME group (n = 261). In the subgroup analysis of early surgical outcomes of the D2 group, the high BMI subgroup had longer surgery time (p = 0.007), more blood loss (p = 0.006) and longer time to first flatus (p = 0.001), compared to the normal BMI subgroup. Conversely, in the D2 + CME group, significant differences were not observed in early surgical outcomes between the two subgroups(p > 0.05). PSM yielded 44 high BMI patients with comparable baseline characteristics into the A group and the B group. Compared to the A group, patients with high BMI in the B group who received laparoscopic D2 + CME had shorter surgery time(p<0.001), less blood loss(p = 0.004), more retrieved lymph nodes (LNs) (p = 0.016). No statistical differences were observed in terms of the first flatus time, pT stage, pN stage, pathological stage(pStage), vascular invasion, postoperative complications, or postoperative hospital stay(p > 0.05).ConclusionOur findings suggest the high BMI status had a significant impact on the early surgical results of laparoscopic conventional D2 lymphadenectomy. However, laparoscopic D2 + CME was unaffected by a high BMI. In addition, patients with high BMI benefit more from laparoscopic D2 + CME in terms of short-term outcomes. Laparoscopic D2 + CME is a recommended technique for distal gastric cancer patients with high BMI, which deserves further study and promotion.

Project description:ImportanceThe long-term safety of laparoscopic distal gastrectomy for locally advanced gastric cancer (AGC) remains uncertain given the lack of 5-year follow-up results.ObjectiveTo compare the 5-year follow-up results in patients with clinically AGC enrolled in the Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS)-02 randomized clinical trial who underwent laparoscopic or open distal gastrectomy.Design, setting, and participantsThe KLASS-02, a multicenter randomized clinical trial, showed that laparoscopic surgery was noninferior to open surgery for patients with locally AGC. The present study assessed the 5-year follow-up results, including 5-year overall survival (OS) and relapse-free survival (RFS) rates and long-term complications, in patients enrolled in KLASS-02. From November 21, 2011, to April 29, 2015, patients aged 20 to 80 years diagnosed preoperatively with locally AGC were enrolled. Final follow-up was on June 15, 2021. Data were analyzed June 24 to September 9, 2021.InterventionsPatients were treated with R0 resection either by laparoscopic gastrectomy or open gastrectomy as the full analysis set of the KLASS-02 trial.Main outcomes and measuresFive-year OS and RFS rates, recurrence patterns, and long-term surgical complications were evaluated.ResultsThis study enrolled a total of 1050 patients. A total of 974 patients were treated with R0 resection; 492 (50.5%) in the laparoscopic gastrectomy group (mean [SD] age, 59.8 [11.0] years; 351 men [71.3%]) and 482 (49.5%) in the open gastrectomy group (mean [SD] age, 59.4 [11.5] years; 335 men [69.5%]). In patients who underwent laparoscopic and open distal gastrectomy, the 5-year OS (88.9% vs 88.7%) and RFS (79.5% vs 81.1%) rates did not differ significantly. The most common types of recurrence were peritoneal carcinomatosis (73 of 173 [42.1%]), hematogenous metastases (36 of 173 [20.8%]), and locoregional recurrence (23 of 173 [13.2%]), with no between-group differences in types of recurrence at each cancer stage. The correlation between 3-year RFS and 5-year OS at the individual level was highest in patients with stage III gastric cancer (ρ = 0.720). The late complication rate was significantly lower in the laparoscopic than in the open surgery group (32 of 492 [6.5%] vs 53 of 482 [11.0%]). The most common type of complication in both groups was intestinal obstruction (13 of 492 [2.6%] vs 24 of 482 [5.0%]).Conclusions and relevanceThe 5-year outcomes of the KLASS-02 trial support the 3-year results, which is the noninferiority of laparoscopic surgery compared with open gastrectomy for locally AGC. The laparoscopic approach can be recommended in patients with locally AGC to achieve the benefit of low incidence of late complications.Trial registrationClinicalTrials.gov Identifier: NCT01456598.

Project description:ImportanceIt 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.ObjectiveTo report 5-year overall survival data from the CLASS-01 trial of laparoscopic vs open distal gastrectomy among patients with locally advanced gastric cancer.Design, setting, and patientsThis 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.InterventionsParticipants 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.Main outcomes and measuresThe 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.ResultsData 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.Conclusions and relevanceThis 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.Trial registrationClinicalTrials.gov Identifier: NCT01609309.

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Complete mesogastric excision for locally advanced gastric cancer: short-term outcomes of a randomized clinical trial.

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Complete mesogastric excision for locally advanced gastric cancer: short-term outcomes of a randomized clinical trial.

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