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前入路与传统肝切除术治疗结直肠癌肝转移的随机临床试验。

Anterior Approach vs Conventional Hepatectomy for Resection of Colorectal Liver Metastasis: A Randomized Clinical Trial.

机构信息

Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.

now affiliated with Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

出版信息

JAMA Surg. 2021 Jan 1;156(1):31-40. doi: 10.1001/jamasurg.2020.5050.

Abstract

IMPORTANCE

Tumor relapse after partial hepatectomy for colorectal liver metastasis (CRLM) remains an unsolved issue. Intraoperative manipulation of the liver during conventional hepatectomy might enhance hematogenous tumor cell spread. The anterior approach is an alternative approach that may reduce intraoperative tumor cell dissemination.

OBJECTIVE

To determine the efficacy and safety of the anterior approach compared with conventional hepatectomy in patients undergoing resection for CRLM.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical study evaluated the efficacy and safety of the anterior approach compared with conventional hepatectomy in adult patients with CRLM who were scheduled for hepatectomy from February 1, 2003, to March 31, 2012, at a tertiary-care hospital. A total of 80 patients with CRLM were randomized to the anterior approach and conventional hepatectomy groups in a 1:1 ratio. Bone marrow and blood samples were analyzed for disseminated tumor cells and circulating tumor cells (CTC) using cytokeratin 20 reverse transcriptase-polymerase chain reaction analysis. Data were analyzed from April 1 to December 1, 2018, using intention to treat.

INTERVENTIONS

Anterior approach vs conventional hepatectomy.

MAIN OUTCOMES AND MEASURES

The primary end point was intraoperative CTC detection in central blood samples after liver resection. Secondary end points included postoperative morbidity, mortality, and long-term survival.

RESULTS

Among the 80 patients included in the analysis (48 men [60%]; mean [SD] age, 61 [10] years), baseline characteristics, including preoperative CTC detection, were comparable between both groups. There was no statistically significant difference in intraoperative CTC detection between patients in the conventional hepatectomy (5 of 21 [24%]) and anterior approach (6 of 22 [27%]) groups (P = .54). Except for a longer operating time in the anterior approach group (mean [SD], 171 [53] vs 221 [53] minutes; P < .001), there were no significant differences in intraoperative and postoperative outcomes between both study groups. Although detection of CTC was associated with poor overall (median, 46 [95% CI, 40-52] vs 81 [95% CI, 54-107] months; P = .03) and disease-free (median, 40 [95% CI, 34-46] vs 60 [95% CI, 46-74] months; P = .04) survival, there was no significant difference in overall (median, 73 [95% CI, 42-104] vs 55 [95% CI, 35-75] months; P = .43) and disease-free (median, 48 [95% CI, 40-56] vs 40 [95% CI, 28-52] months; P = .88) survival between the conventional hepatectomy and anterior approach groups. Also, there was no significant difference in patterns of recurrence between both groups.

CONCLUSIONS AND RELEVANCE

This randomized clinical trial found that the anterior approach was not superior to conventional hepatectomy in reducing intraoperative tumor cell dissemination in patients undergoing resection of CRLM.

TRIAL REGISTRATION

isrctn.org Identifier: ISRCTN45066244.

摘要

重要性

结直肠癌肝转移(CRLM)患者行部分肝切除术后肿瘤复发仍是一个未解决的问题。在常规肝切除术中对肝脏的术中操作可能会增强血源性肿瘤细胞的播散。前入路是一种替代方法,可能会减少术中肿瘤细胞的扩散。

目的

确定前入路与常规肝切除术在接受 CRLM 切除术的患者中的疗效和安全性。

设计、地点和参与者:这项随机临床研究评估了前入路与常规肝切除术在 2003 年 2 月 1 日至 2012 年 3 月 31 日在一家三级医院接受肝切除术的 CRLM 成年患者中的疗效和安全性。80 例 CRLM 患者按 1:1 的比例随机分为前入路组和常规肝切除术组。使用细胞角蛋白 20 逆转录-聚合酶链反应分析分析骨髓和血液样本中的播散肿瘤细胞和循环肿瘤细胞(CTC)。数据于 2018 年 4 月 1 日至 12 月 1 日采用意向治疗进行分析。

干预措施

前入路与常规肝切除术。

主要结局和测量指标

主要终点是肝切除后中央血样中术中 CTC 的检测。次要终点包括术后发病率、死亡率和长期生存。

结果

在分析的 80 例患者(48 例男性[60%];平均[标准差]年龄 61[10]岁)中,两组患者的基线特征(包括术前 CTC 检测)均无统计学差异。常规肝切除术组(21 例中有 5 例[24%])和前入路组(22 例中有 6 例[27%])患者术中 CTC 检测无统计学差异(P = .54)。除前入路组手术时间较长(平均[标准差]171[53]比 221[53]分钟;P < .001)外,两组患者术中及术后结局均无显著差异。虽然 CTC 的检测与总体生存率(中位数,46[95%CI,40-52]与 81[95%CI,54-107]个月;P = .03)和无病生存率(中位数,40[95%CI,34-46]与 60[95%CI,46-74]个月;P = .04)较差相关,但常规肝切除术组与前入路组之间的总体生存率(中位数,73[95%CI,42-104]与 55[95%CI,35-75]个月;P = .43)和无病生存率(中位数,48[95%CI,40-56]与 40[95%CI,28-52]个月;P = .88)无显著差异。此外,两组之间的复发模式也没有显著差异。

结论和相关性

这项随机临床试验发现,前入路在减少 CRLM 切除术患者术中肿瘤细胞播散方面并不优于常规肝切除术。

试验注册

isrctn.org 标识符:ISRCTN45066244。

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