Lord Amy C, Moran Brendan, Abulafi Muti, Rasheed Shahnawaz, Nagtegaal Iris D, Terlizzo Monica, Brown Gina
Department of General Surgery, Royal Marsden NHS Foundation Trust, London, UK
Department of General Surgery, Croydon University Hospital, Croydon, UK.
BMJ Open. 2020 Oct 7;10(10):e033395. doi: 10.1136/bmjopen-2019-033395.
Tumour deposits (TDs) are a poor prognostic marker when seen on pathology, and are worse than lymph node metastases (LNMs). They are now being reported on MRI as discontinuous nodules of extramural venous invasion but this diagnosis has not been validated and it is unclear how it correlates with the diagnosis of TDs on pathology.
This is a prospective interventional clinical trial which aims to directly map the location of TDs on MRI and correlate what is seen on MRI with the pathology findings at each location. All patients with rectal cancer undergoing resectional surgery are eligible (including those undergoing preoperative therapy). The primary outcome is the prevalence of TDs seen on pathology. Secondary outcomes are to assess radiological and pathological interobserver agreement, assess the effect of TDs on prognosis and carry out exploratory work looking at differences between TDs and LNMs. The estimated sample size is 100 to detect a twofold increase in the pathological diagnosis of TD when MRI mapping is used.
Ethical approval has been granted from the South Central-Hampshire B Research and Ethics Committee (IRAS 217627). The study will be carried out under standard operative procedures within the Royal Marsden Hospital.
NCT03303547.
肿瘤沉积物（TDs）在病理学检查中是一种预后不良的标志物，且比淋巴结转移（LNMs）情况更糟。目前在磁共振成像（MRI）上，它们被报告为壁外静脉侵犯的不连续结节，但这一诊断尚未得到验证，且尚不清楚其与病理学上TDs诊断的相关性。
这是一项前瞻性干预性临床试验，旨在直接在MRI上定位TDs，并将MRI所见与每个部位的病理学结果相关联。所有接受根治性手术的直肠癌患者均符合条件（包括接受术前治疗的患者）。主要结局是病理学上TDs的患病率。次要结局包括评估影像学和病理学观察者间的一致性、评估TDs对预后的影响以及开展探索性工作以研究TDs与LNMs之间的差异。估计样本量为100例，以检测使用MRI定位时TDs病理诊断增加两倍的情况。
已获得中南-汉普郡B研究与伦理委员会的伦理批准（IRAS 217627）。该研究将在皇家马斯登医院的标准手术程序下进行。
NCT03303547。
