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开腹与微创肝脏手术治疗结直肠癌肝转移(LapOpHuva):一项前瞻性随机对照试验。

Open versus minimally invasive liver surgery for colorectal liver metastases (LapOpHuva): a prospective randomized controlled trial.

机构信息

Department of Liver Surgery and Transplantation, Virgen de la Arrixaca Clinic and University Hospital, IMIB, El Palmar, Murcia, Spain.

出版信息

Surg Endosc. 2019 Dec;33(12):3926-3936. doi: 10.1007/s00464-019-06679-0. Epub 2019 Jan 30.

DOI:10.1007/s00464-019-06679-0
PMID:30701365
Abstract

OBJECTIVE

To present surgical and oncological outcomes using a prospective and randomized trial (LapOpHuva, NCT02727179) comparing minimally invasive liver resection (LLR) versus open liver resection (OLR) in patients with colorectal liver metastases (CRLM).

METHODS

Between February 2005 and March 2016, 204 selected patients with CRLM were randomized and 193 were included: LLR (n = 96) and OLR (n = 97). The primary endpoint was to compare postoperative morbidity. Other secondary endpoints were oncological outcomes, use of the Pringle maneuver, surgical time, blood losses, transfusions, hospital stay, mortality and OS, and disease-free survival (DFS) at 3, 5, and 7 years.

RESULTS

LLR presented with lower global morbidity (11.5% vs. 23.7%, p = 0.025) but with similar severe complications. Long-term survival outcomes were similar in both groups. The cumulative 1-, 3-, 5-, 7-year OS for LLR and OLR were 92.5%, 71.5%, 49.3%, 35.6% versus 93.6%, 69.7%, 47.4%, 35.5%, respectively (log-rank = 0.047, p = 0.82). DFS for LLR and OLR was 72.7%, 33.5%, 22.7%, and 20.8% versus 61.6%, 27.2%, 23.9%, and 17.9%, respectively (log-rank = 1.427, p = 0.23). LLR involved more use of the Pringle maneuver (15.5% vs. 30.2%, p = 0.025) and a shorter hospital stay (4 vs. 6 days, p < 0.001). There were no differences regarding surgical time, blood losses, transfusion, and mortality.

CONCLUSIONS

In selected patients with CRLM, LLR presents similar oncological outcomes with the advantages of the short-term results associated with LLR.

摘要

目的

通过前瞻性、随机试验(LapOpHuva,NCT02727179)报告手术和肿瘤学结果,比较微创肝切除术(LLR)与开腹肝切除术(OLR)在结直肠癌肝转移(CRLM)患者中的应用。

方法

2005 年 2 月至 2016 年 3 月,对 204 例 CRLM 患者进行了随机分组,其中 193 例患者入组:LLR(n=96)和 OLR(n=97)。主要终点是比较术后发病率。其他次要终点包括肿瘤学结果、Pringle 操作的使用、手术时间、出血量、输血、住院时间、死亡率和总生存期(OS),以及 3、5 和 7 年的无病生存期(DFS)。

结果

LLR 的总体发病率较低(11.5% vs. 23.7%,p=0.025),但严重并发症相似。两组的长期生存结果相似。LLR 和 OLR 的累积 1、3、5、7 年 OS 分别为 92.5%、71.5%、49.3%、35.6%和 93.6%、69.7%、47.4%、35.5%(log-rank=0.047,p=0.82)。LLR 和 OLR 的DFS 分别为 72.7%、33.5%、22.7%和 20.8%和 61.6%、27.2%、23.9%和 17.9%(log-rank=1.427,p=0.23)。LLR 更频繁地使用Pringle 操作(15.5% vs. 30.2%,p=0.025)和较短的住院时间(4 天 vs. 6 天,p<0.001)。手术时间、出血量、输血和死亡率无差异。

结论

在选择的 CRLM 患者中,LLR 具有相似的肿瘤学结果,并具有与 LLR 相关的短期结果的优势。

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