腹腔镜与开腹结直肠肝转移灶切除术的长期肿瘤学结果：一项随机试验。

Long-Term Oncologic Outcomes After Laparoscopic Versus Open Resection for Colorectal Liver Metastases : A Randomized Trial.

机构信息

The Intervention Centre at Oslo University Hospital and Institute of Clinical Medicine at University of Oslo, Oslo, Norway, and Yerevan State Medical University after Mkhitar Heratsi, Yerevan, Armenia (D.L.A.).

The Intervention Centre at Oslo University Hospital, Oslo, and Østfold Hospital Trust, Grålum, Norway, Yerevan State Medical University after Mkhitar Heratsi, Yerevan, Armenia, and I.M. Sechenov First Moscow State Medical University, Moscow, Russia (A.M.K.).

出版信息

Ann Intern Med. 2021 Feb;174(2):175-182. doi: 10.7326/M20-4011. Epub 2020 Nov 17.

DOI:10.7326/M20-4011

PMID:33197213

Abstract

BACKGROUND

Despite the recent worldwide dissemination of laparoscopic liver surgery, no high-level evidence supports the oncologic safety of this approach.

OBJECTIVE

To evaluate long-term oncologic outcomes after laparoscopic versus open liver resection in patients with colorectal metastases.

DESIGN

A single-center, assessor-blinded, randomized controlled trial (OSLO-COMET [Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Trial]). (ClinicalTrials.gov: NCT01516710).

SETTING

Oslo University Hospital, the only provider of liver surgery for the 3 million inhabitants of southeastern Norway.

PARTICIPANTS

Patients with resectable colorectal liver metastases were randomly assigned to have open or laparoscopic liver resection.

INTERVENTION

From February 2012 to January 2016, a total of 280 patients were included in the trial (laparoscopic surgery: = 133; open surgery: = 147).

MEASUREMENTS

The primary outcome was postoperative morbidity within 30 days. Five-year rates of overall and recurrence-free survival were predefined secondary end points.

RESULTS

At a median follow-up of 70 months, rates of 5-year overall survival were 54% in the laparoscopic group and 55% in the open group (between-group difference, 0.5 percentage point [95% CI, -11.3 to 12.3 percentage points]; hazard ratio, 0.93 [CI, 0.67 to 1.30]; = 0.67). Rates of 5-year recurrence-free survival were 30% in the laparoscopic group and 36% in the open group (between-group difference, 6.0 percentage points [CI, -6.7 to 18.7 percentage points]; hazard ratio, 1.09 [CI, 0.80 to 1.49]; = 0.57).

LIMITATION

The trial was not powered to detect differences in secondary end points and was not designed to address a noninferiority hypothesis for survival outcomes.

CONCLUSION

In this randomized trial of laparoscopic and open liver surgery, no difference in survival outcomes was found between the treatment groups. However, differences in 5-year overall survival up to about 10 percentage points in either direction cannot be excluded. This trial should be followed by pragmatic multicenter trials and international registries.

PRIMARY FUNDING SOURCE

The South-Eastern Norway Regional Health Authority.

摘要

背景

尽管腹腔镜肝切除术在全球范围内得到了广泛应用，但目前尚无高级别证据支持该术式的肿瘤安全性。

目的

评估腹腔镜与开腹肝切除术治疗结直肠癌肝转移患者的长期肿瘤学结局。

设计

单中心、评估者设盲、随机对照试验（OSLO-COMET [奥斯陆随机腹腔镜与开腹肝切除术治疗结直肠癌肝转移试验]）。（ClinicalTrials.gov：NCT01516710）。

地点

奥斯陆大学医院，该医院是挪威东南部 300 万居民唯一的肝脏手术提供者。

患者

符合可切除结直肠癌肝转移标准的患者被随机分配行开腹或腹腔镜肝切除术。

干预

从 2012 年 2 月至 2016 年 1 月，共有 280 例患者参与了这项试验（腹腔镜手术组：=133；开腹手术组：=147）。

测量

术后 30 天内的发病率是主要结局。总生存和无复发生存率 5 年是预设的次要结局。

结果

在中位随访 70 个月时，腹腔镜组的 5 年总生存率为 54%，开腹组为 55%（组间差异，0.5 个百分点[95%CI，-11.3 至 12.3 个百分点]；风险比，0.93[CI，0.67 至 1.30]；=0.67）。腹腔镜组的 5 年无复发生存率为 30%，开腹组为 36%（组间差异，6.0 个百分点[CI，-6.7 至 18.7 个百分点]；风险比，1.09[CI，0.80 至 1.49]；=0.57）。