Vascular calcification does not predict anastomotic leak or conduit necrosis following oesophagectomy

BACKGROUND Anastomotic leaks(AL)and gastric conduit necrosis(CN)are serious complications following oesophagectomy.Some studies have suggested that vascular calcification may be associated with an increased AL rate,but this has not been validated in a United Kingdom population.AIM To investigate whether vascular calcification identified on the pre-operative computed tomography(CT)scan is predictive of AL or CN.METHODS Routine pre-operative CT scans of 414 patients who underwent oesophagectomy for malignancy with oesophagogastric anastomosis at the Queen Elizabeth Hospital Birmingham between 2006 and 2018 were retrospectively analysed.Calcification of the proximal aorta,distal aorta,coeliac trunk and branches of the coeliac trunk was scored by two reviewers.The relationship between these calcification scores and occurrence of AL and CN was then analysed.The Esophagectomy Complications Consensus Group definition of AL and CN was used.RESULTS Complication data were available in n=411 patients,of whom 16.7%developed either AL(15.8%)or CN(3.4%).Rates of AL were significantly higher in female patients,at 23.0%,compared to 13.9%in males(P=0.047).CN was significantly more common in females,(8.0%vs 2.2%,P=0.014),patients with diabetes(10.6%vs 2.5%,P=0.014),a history of smoking(10.3%vs 2.3%,P=0.008),and a higher American Society of Anaesthesiologists grade(P=0.024).Out of the 14 conduit necroses,only 4 occurred without a concomitant AL.No statistically significant association was found between calcification of any of the vessels studied and either of these outcomes.Multivariable analyses were then performed to identify whether a combination of the calcification scores could be identified that would be significantly predictive of any of the outcomes.However,the stepwise approach did not select any factors for inclusion in the final models.The analysis was repeated for composite outcomes of those patients with either AL or CN(n=69,16.7%)and for those with both AL and CN(n=10,2.4%)and again,no significant associations were detected.In the subset of patients that developed these outcomes,no significant associations were detected between calcification and the severity of the complication.CONCLUSION Calcification scoring was not significantly associated with Anastomotic Leak or CN in our study,therefore should not be used to identify patients who are high risk for these complications.

以患者为中心的疗效研究:定性和混合方法研究的方法学标准

以患者为中心的疗效研究所(The Patient-Centered Outcomes Research Institute,PCORI)开发的定性和混合方法研究的方法学标准有助于确保研究的设计和实施可以产生人们所需的证据,来回答患者和临床医生关于哪种方法最有效,对谁最有效,在什么情况下最有效的问题。这套标准围绕以患者为中心的疗效研究的相关要素而制定,但也可为其他类型的临床研究提供指导。此标准可用于制定研究方案并对其进行评价、实施研究,以及解释研究结果。标准开发遵循系统的程序,即研究关键方法学问题的范围及其潜在标准,将范围缩小聚焦到最重要的标准上,起草标准初稿,征求同行专家组和广大公众的反馈意见,基于反馈意见确定标准终稿,供PCORI理事会审查并采纳。本文提供了一个例子,说明如何应用这些标准撰写研究计划书。