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局部进展期胃癌的微创与开放远端胃切除术:随机试验的序贯分析

Minimally Invasive Versus Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Trial Sequential Analysis of Randomized Trials.

作者信息

Aiolfi Alberto, Calì Matteo, Cammarata Francesco, Grasso Federica, Bonitta Gianluca, Biondi Antonio, Bonavina Luigi, Bona Davide

机构信息

IRCCS Ospedale Galeazzi-Sant'Ambrogio, Division of General Surgery, Department of Biomedical Science for Health, University of Milan, Via C. Belgioioso, 173, 20157 Milan, Italy.

G. Rodolico Hospital, Surgical Division, Department of General Surgery and Medical Surgical Specialties, University of Catania, 95131 Catania, Italy.

出版信息

Cancers (Basel). 2024 Dec 6;16(23):4098. doi: 10.3390/cancers16234098.

Abstract

BACKGROUND

Minimally invasive distal gastrectomy (MIDG) has been shown to be associated with improved short-term outcomes compared to open distal gastrectomy (ODG) in patients with locally advanced gastric cancer (LAGC). The impact of MIDG on long-term patient survival remains debated. Aim was to compare the MIDG vs. ODG effect on long-term survival.

METHODS

Systematic review and trial sequential analysis (TSA) of randomized controlled trials (RCTs). Web of Science, Scopus, MEDLINE, the Cochrane Central Library, and ClinicalTrials.gov were queried. Hazard ratio (HR) and 95% confidence intervals (CI) were used as pooled effect size measures. Five-year overall (OS) and disease-free survival (DFS) were primary outcomes.

RESULTS

Five RCTs were included (2835 patients). Overall, 1421 (50.1%) patients underwent MIDG and 1414 (49.9%) ODG. The ages ranged from 48 to 70 years and 63.4% were males. The pooled 5-year OS (HR = 0.86; 95% CI 0.70-1.04; I = 0.0%) and 5-year DFS (HR = 1.03; 95% CI 0.87-1.23; I = 0.0%) were similar for MIDG vs. ODG. The TSA shows a cumulative z-curve without crossing the monitoring boundaries line (Z = 1.96), thus suggesting not conclusive 5-year OS and DFS results because the total information size was not sufficient.

CONCLUSIONS

MIDG and ODG seem to have equivalent 5-year OS and DFS in patients with LAGC. However, the cumulative evidence derived from the TSA showed that the actual information size is not sufficient to provide conclusive data.

摘要

背景

在局部晚期胃癌(LAGC)患者中,与开放远端胃切除术(ODG)相比,微创远端胃切除术(MIDG)已被证明与改善短期预后相关。MIDG对患者长期生存的影响仍存在争议。目的是比较MIDG与ODG对长期生存的影响。

方法

对随机对照试验(RCT)进行系统评价和试验序贯分析(TSA)。检索了Web of Science、Scopus、MEDLINE、Cochrane中央图书馆和ClinicalTrials.gov。风险比(HR)和95%置信区间(CI)用作合并效应量指标。五年总生存(OS)和无病生存(DFS)是主要结局。

结果

纳入了五项RCT(2835例患者)。总体而言,1421例(50.1%)患者接受了MIDG,1414例(49.9%)接受了ODG。年龄范围为48至70岁,63.4%为男性。MIDG与ODG的合并5年OS(HR = 0.86;95% CI 0.70 - 1.04;I² = 0.0%)和5年DFS(HR = 1.03;95% CI 0.87 - 1.23;I² = 0.0%)相似。TSA显示累积z曲线未越过监测边界线(Z = 1.96),因此表明5年OS和DFS结果尚无定论,因为总信息量不足。

结论

在LAGC患者中,MIDG和ODG似乎具有等效的5年OS和DFS。然而,TSA得出的累积证据表明,实际信息量不足以提供确凿的数据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5984/11640675/07e8c89816c2/cancers-16-04098-g001.jpg

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