腹腔镜与开腹肝后上段切除术在强化康复方案中的比较（ORANGE 节段）：一项多中心随机对照试验的研究方案。
Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial.
机构信息
Hepatobiliary and Pancreatic Surgical Unit, University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, UK.
Department of Surgery, Foundation Poliambulanza, Via Bissolati, Brescia, Italy.
出版信息
Trials. 2022 Mar 9;23(1):206. doi: 10.1186/s13063-022-06112-3.
BACKGROUND
A shift towards parenchymal-sparing liver resections in open and laparoscopic surgery emerged in the last few years. Laparoscopic liver resection is technically feasible and safe, and consensus guidelines acknowledge the laparoscopic approach in the posterosuperior segments. Lesions situated in these segments are considered the most challenging for the laparoscopic approach. The aim of this trial is to compare the postoperative time to functional recovery, complications, oncological safety, quality of life, survival and costs after laparoscopic versus open parenchymal-sparing liver resections in the posterosuperior liver segments within an enhanced recovery setting.
METHODS
The ORANGE Segments trial is an international multicentre randomised controlled superiority trial conducted in centres experienced in laparoscopic liver resection. Eligible patients for minor resections in the posterosuperior segments will be randomised in a 1:1 ratio to undergo laparoscopic or open resections in an enhanced recovery setting. Patients and ward personnel are blinded to the treatment allocation until postoperative day 4 using a large abdominal dressing. The primary endpoint is time to functional recovery. Secondary endpoints include intraoperative outcomes, length of stay, resection margin, postoperative complications, 90-day mortality, time to adjuvant chemotherapy initiation, quality of life and overall survival. Laparoscopic liver surgery of the posterosuperior segments is hypothesised to reduce time to functional recovery by 2 days in comparison with open surgery. With a power of 80% and alpha of 0.04 to adjust for interim analysis halfway the trial, a total of 250 patients are required to be randomised.
DISCUSSION
The ORANGE Segments trial is the first multicentre international randomised controlled study to compare short- and long-term surgical and oncological outcomes of laparoscopic and open resections in the posterosuperior segments within an enhanced recovery programme.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03270917 . Registered on September 1, 2017. Before start of inclusion.
PROTOCOL VERSION
version 12, May 9, 2017.
背景
近年来，开放手术和腹腔镜手术中出现了向保留肝实质的肝切除术转变的趋势。腹腔镜肝切除术在技术上是可行和安全的，共识指南也承认在后上肝段的腹腔镜方法。位于这些节段的病变被认为是腹腔镜方法最具挑战性的。本试验的目的是在强化康复环境中，比较腹腔镜与开放保留肝实质肝切除术在后上肝段的术后功能恢复时间、并发症、肿瘤安全性、生活质量、生存率和成本。
方法
ORANGE Segments 试验是一项在腹腔镜肝切除术经验丰富的中心进行的国际多中心随机对照优效性试验。在后上肝段进行小切除术的合格患者将按 1:1 的比例随机分为在强化康复环境下接受腹腔镜或开放切除术。患者和病房人员在术后第 4 天使用大腹部敷料之前对治疗分配保持盲态。主要终点是功能恢复时间。次要终点包括术中结果、住院时间、切除边缘、术后并发症、90 天死亡率、辅助化疗开始时间、生活质量和总生存率。与开放手术相比，腹腔镜后上肝段肝切除术假设可将功能恢复时间缩短 2 天。在试验中途进行中期分析时，需要 250 名患者随机分组，以达到 80%的功效和 0.04 的α值来调整。
讨论
ORANGE Segments 试验是第一项比较强化康复方案下腹腔镜和开放切除在后上肝段的短期和长期手术及肿瘤学结果的多中心国际随机对照研究。
试验注册
ClinicalTrials.gov NCT03270917。2017 年 9 月 1 日注册。在纳入开始之前。
方案版本
第 12 版，2017 年 5 月 9 日。
Zotero 插件