Swiss HPB and Transplant Center Zurich, Department of Surgery and Transplantation, University Hospital Zurich, Switzerland.
Department of HPB Surgery and Liver Transplantation, Royal Free London Hospital, NHS Foundation Trust, London, United Kingdom.
Ann Surg. 2019 Nov;270(5):835-841. doi: 10.1097/SLA.0000000000003539.
The aim of this study was to use the concept of benchmarking to establish robust and standardized outcome references after the procedure ALPPS (Associating Liver Partition and Portal Vein Ligation for Staged hepatectomy).
The recently developed ALPPS procedure, aiming at removing primarily unresectable liver tumors, has been criticized for safety issues with high variations in the reported morbidity/mortality rates depending on patient, disease, technical characteristics, and center experience. No reference values for relevant outcome parameters are available.
Among 1036 patients registered in the international ALPPS registry, 120 (12%) were benchmark cases fulfilling 4 criteria: patients ≤67 years of age, with colorectal metastases, without simultaneous abdominal procedures, and centers having performed ≥30 cases. Benchmark values, defined as the 75th percentile of the median outcome parameters of the centers, were established for 10 clinically relevant domains.
The benchmark values were completion of stage 2: ≥96%, postoperative liver failure (ISGLS-criteria) after stage 2: ≤5%, ICU stay after ALPPS stages 1 and 2: ≤1 and ≤2 days, respectively, interstage interval: ≤16 days, hospital stay after ALPPS stage 2: ≤10 days, rates of overall morbidity in combining both stage 1 and 2: ≤65% and for major complications (grade ≥3a): ≤38%, 90-day comprehensive complication index was ≤22, the 30-, 90-day, and 6-month mortality was ≤4%, ≤5%, and 6%, respectively, the overall 1-year, recurrence-free, liver-tumor-free, and extrahepatic disease-free survival was ≥86%, ≥50%, ≥57%, and ≥65%, respectively.
This benchmark analysis sets key reference values for ALPPS, indicating similar outcome as other types of major hepatectomies. Benchmark cutoffs offer valid tools not only for comparisons with other procedures, but also to assess higher risk groups of patients or different indications than colorectal metastases.
本研究旨在通过基准测试的概念，为 ALPPS（联合肝脏离断和门静脉结扎的分阶段肝切除术）后建立稳健且标准化的结果参考。
最近开发的 ALPPS 手术旨在切除主要不可切除的肝肿瘤，但由于患者、疾病、技术特点和中心经验的差异，其报告的发病率/死亡率存在安全问题，报道的发病率/死亡率差异较大。目前尚无相关结局参数的参考值。
在国际 ALPPS 注册中心登记的 1036 例患者中，有 120 例（12%）为基准病例，符合以下 4 个标准：年龄≤67 岁、结直肠转移、无同期腹部手术、中心完成≥30 例。基准值定义为中心中位数的第 75 个百分位数，确定了 10 个临床相关领域的基准值。
基准值为：完成第 2 阶段≥96%、第 2 阶段后发生术后肝衰竭（ISGLS 标准）≤5%、ALPPS 第 1 阶段和第 2 阶段后 ICU 入住时间分别为≤1 天和≤2 天、间隔期≤16 天、ALPPS 第 2 阶段后住院时间≤10 天、第 1 阶段和第 2 阶段总发病率合并率≤65%，主要并发症（≥3a 级）率≤38%，90 天综合并发症指数≤22，30 天、90 天和 6 个月死亡率分别为≤4%、≤5%和≤6%，总 1 年、无复发生存率、无肝肿瘤生存率和无肝外疾病生存率分别≥86%、≥50%、≥57%和≥65%。
该基准分析为 ALPPS 设定了关键的参考值，表明其结局与其他类型的主要肝切除术相似。基准截止值不仅为与其他手术进行比较提供了有效工具，而且还为评估结直肠转移以外的高危患者群体或不同适应证提供了有效工具。
