Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway.
Ann Surg. 2018 May;267(5):833-840. doi: 10.1097/SLA.0000000000002511.
The aim of the study was to evaluate if associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) could increase resection rates (RRs) compared with two-stage hepatectomy (TSH) in a randomized controlled trial (RCT).
Radical liver metastasis resection offers the only chance of a cure for patients with metastatic colorectal cancer. Patients with colorectal liver metastasis (CRLM) and an insufficient future liver remnant (FLR) volume are traditionally treated with chemotherapy with portal vein embolization or ligation followed by hepatectomy (TSH). This treatment sometimes fails due to insufficient liver growth or tumor progression.
A prospective, multicenter RCT was conducted between June 2014 and August 2016. It included 97 patients with CRLM and a standardized FLR (sFLR) of less than 30%. Primary outcome-RRs were measured as the percentages of patients completing both stages of the treatment. Secondary outcomes were complications, radicality, and 90-day mortality measured from the final intervention.
Baseline characteristics, besides body mass index, did not differ between the groups. The RR was 92% [95% confidence interval (CI) 84%-100%] (44/48) in the ALPPS arm compared with 57% (95% CI 43%-72%) (28/49) in the TSH arm [rate ratio 8.25 (95% CI 2.6-26.6); P < 0.0001]. No differences in complications (Clavien-Dindo ≥3a) [43% (19/44) vs 43% (12/28)] [1.01 (95% CI 0.4-2.6); P = 0.99], 90-day mortality [8.3% (4/48) vs 6.1% (3/49)] [1.39 [95% CI 0.3-6.6]; P = 0.68] or R0 RRs [77% (34/44) vs 57% (16/28)] [2.55 [95% CI 0.9-7.1]; P = 0.11)] were observed. Of the patients in the TSH arm that failed to reach an sFLR of 30%, 12 were successfully treated with ALPPS.
ALPPS is superior to TSH in terms of RR, with comparable surgical margins, complications, and short-term mortality.
本研究旨在评估与两阶段肝切除术（two-stage hepatectomy，TSH）相比，联合肝脏离断和门静脉结扎的分期肝切除术（associating liver partition and portal vein ligation for staged hepatectomy，ALPPS）能否在随机对照试验（randomized controlled trial，RCT）中提高切除率（resection rates，RRs）。
根治性肝转移灶切除术是结直肠癌肝转移（colorectal liver metastasis，CRLM）患者治愈的唯一机会。传统上，对于未来肝脏残余量（future liver remnant，FLR）不足的结直肠肝转移（colorectal liver metastasis，CRLM）患者，采用化疗联合门静脉栓塞或结扎，随后行肝切除术（TSH）进行治疗。由于肝生长不足或肿瘤进展，这种治疗有时会失败。
本研究是一项于 2014 年 6 月至 2016 年 8 月进行的前瞻性、多中心 RCT。共纳入 97 例 CRLM 患者，FLR 标准化（standardized FLR，sFLR）<30%。主要结局-RRs 以完成治疗两个阶段的患者百分比进行测量。次要结局是并发症、根治性和从最后一次干预开始的 90 天死亡率。
两组患者除体重指数外，基线特征无差异。ALPPS 组 RR 为 92%[95%置信区间（confidence interval，CI）84%-100%]（44/48），TSH 组为 57%[95% CI 43%-72%]（28/49）[RR 8.25（95% CI 2.6-26.6）；P<0.0001]。两组并发症（Clavien-Dindo≥3a）[43%（19/44）与 43%（12/28）]（1.01[95% CI 0.4-2.6]；P=0.99）、90 天死亡率[8.3%（4/48）与 6.1%（3/49）]（1.39[95% CI 0.3-6.6]；P=0.68）或 R0 RR[77%（34/44）与 57%（16/28）]（2.55[95% CI 0.9-7.1]；P=0.11）均无差异。TSH 组未能达到 30%sFLR 的患者中，12 例成功接受了 ALPPS 治疗。
与 TSH 相比，ALPPS 在 RR 方面具有优势，且手术切缘、并发症和短期死亡率相当。
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