Abstract
The aim was to evaluate 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. A prospective, multicenter RCT was conducted between June 2014 and August 2016. It included 97 patients with CRLM and a standardized FLR (sFLR) of < 30%. Primary outcome, resection rates (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% (C.I. 84-100%)(44/48) in the ALPPS arm compared to 57% (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 a 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.
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