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术中延长腹腔灌洗预防局部进展期胃癌腹膜复发的前瞻性随机对照研究。

Extended intraoperative peritoneal lavage as prophylactic peritoneal recurrence for locally advanced gastric cancer: a prospective randomized trial.

机构信息

Department of Surgery, Gastro-Oesophageal Surgery Unit, Hospital Universitari Mútua de Terrassa, University of Barcelona, Plaza Dr. Robert, n. 5, 08221, Terrassa, Barcelona, Spain.

Gastro-Oesophageal Surgery Unit, Consorci Sanitari Parc Taulí, Sabadell, Spain.

出版信息

Clin Transl Oncol. 2021 Sep;23(9):1857-1865. doi: 10.1007/s12094-021-02596-8. Epub 2021 Apr 1.

DOI:10.1007/s12094-021-02596-8
PMID:33792839
Abstract

BACKGROUND

To demonstrate whether extensive intraoperative peritoneal lavage (EIPL) could yield better results in overall survival and less recurrence, regardless of peritoneal cytology, compared to standard peritoneal lavage (SPL).

METHODS

A prospective randomised multicenter study including 94 patients (47 per arm) to detect a 20% difference in 3-year overall survival in patients with locally advanced tumours without peritoneal carcinomatosis. Three samples of peritoneal fluid were obtained (at the beginning, the end of procedure and after the assigned peritoneal lavage). Clinicopathological and surgical data were analysed by group. Postoperative complications, location of recurrence and surgical approach were evaluated. Overall survival was calculated by the Kaplan-Meier method and the uni/multivariate analysis for prognostic factors was carried out using Cox regression analysis.

RESULTS

A total of 86 patients were analysed (4 excluded per group). No statistical differences were observed in clinicopathological or surgical data between groups, considering both groups well-balanced for analysis. Overall survival at 3 years was 64.3% for SPL vs. 62.3% for EIPL (p 0.421). Only three patients had at least one positive peritoneal cytology (1:2). There were no differences regarding postoperative complications (SPL: 37.2% vs. EIPL: 32.5%, p 0.65) or between location of recurrence and number of recurrences. The number of recurrences did not differ between surgical approaches, but locoregional and peritoneal recurrences were fewer with the laparoscopic approach (p 0.048).

CONCLUSIONS

The regular use of extensive peritoneal lavage in patients with locally advanced gastric cancer, regardless of peritoneal cytology, has not been effective as prophylaxis of peritoneal recurrence or better survival.

摘要

背景

为了证明广泛腹腔灌洗(EIPL)是否可以在总生存和减少复发方面取得更好的结果,而与腹腔细胞学无关,与标准腹腔灌洗(SPL)相比。

方法

一项前瞻性随机多中心研究纳入了 94 例患者(每组 47 例),以检测无腹膜癌病的局部晚期肿瘤患者 3 年总生存率提高 20%。采集了 3 份腹腔液样本(开始时、手术结束时和分配的腹腔灌洗后)。通过组分析临床病理和手术数据。评估术后并发症、复发部位和手术方法。通过 Kaplan-Meier 法计算总生存率,并使用 Cox 回归分析对预后因素进行单/多因素分析。

结果

共分析了 86 例患者(每组排除 4 例)。考虑到两组分析均衡,两组在临床病理和手术数据方面无统计学差异。SPL 组 3 年总生存率为 64.3%,EIPL 组为 62.3%(p 0.421)。只有 3 例患者至少有一次阳性腹腔细胞学(1:2)。术后并发症(SPL:37.2% vs. EIPL:32.5%,p 0.65)或复发部位和复发次数无差异。手术方法之间复发次数无差异,但腹腔镜方法局部和腹膜复发较少(p 0.048)。

结论

在局部晚期胃癌患者中,无论腹腔细胞学如何,常规使用广泛腹腔灌洗作为腹膜复发的预防或改善生存均无效。

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本文引用的文献

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A proposal of a practical and optimal prophylactic strategy for peritoneal recurrence.腹腔复发的实用且优化的预防策略提案。
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Mechanisms of peritoneal metastasis after operation for non-serosa-invasive gastric carcinoma: an ultrarapid detection system for intraperitoneal free cancer cells and a prophylactic strategy for peritoneal metastasis.非浆膜浸润性胃癌术后腹膜转移机制:腹腔游离癌细胞超快速检测系统及腹膜转移预防策略
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Does Extended Intraoperative Peritoneal Lavage Really Bring Benefit on Patients With Gastric Cancer? A Meta-Analysis of Published Clinical Trials.
术中延长腹腔冲洗真的能给胃癌患者带来益处吗?已发表临床试验的荟萃分析
Front Oncol. 2021 Aug 24;11:715040. doi: 10.3389/fonc.2021.715040. eCollection 2021.