CHU Cavale Blanche, Brest, France
CHU Cavale Blanche, Brest, France.
BMJ Open. 2024 May 15;14(5):e075712. doi: 10.1136/bmjopen-2023-075712.
Pulmonary embolism (PE) is a challenge to diagnose and when missed, exposes patients to potentially fatal recurrent events. Beyond CT pulmonary angiography (CTPA) and planar ventilation/perfusion (V/Q) scan, single photon emission CT (SPECT) V/Q emerged a new diagnostic modality of scintigraphic acquisition that has been reported to improve diagnostic performances. To date, no management outcome study or randomised trial evaluated an algorithm based on SPECT V/Q for PE diagnosis. We present the design of a randomised multicentre, international management study comparing SPECT V/Q with validated strategies.
We will include a total of 3672 patients with suspected PE requiring chest imaging, randomised into three different groups, each using a different diagnostic strategy based on SPECT V/Q, CTPA and planar V/Q scan. Randomisation will be unbalanced (2:1:1), with twice as many patients in SPECT V/Q arm (n=1836) as in CTPA and planar V/Q arms (n=918 in each). Our primary objective will be to determine whether a diagnostic strategy based on SPECT V/Q is non-inferior to previously validated strategies in terms of diagnostic exclusion safety as assessed by the 3-month risk of thromboembolism in patients with a negative diagnostic workup. Secondary outcomes will be the proportion of patients diagnosed with PE in each arm, patients requiring additional tests, the incidence of major and clinically relevant non-major bleeding and the incidence and cause of death in each arm.
This trial is funded by a grant from Brest University Hospital and by INVENT. The study protocol was approved by Biomedical Research Ethics Committee. The investigator or delegate will obtain signed informed consent from all patients prior to inclusion in the trial. Our results will inform future clinical practice guidelines and solve the current discrepancy between nuclear medicine guidelines and clinical scientific society guidelines.
NCT02983760.
肺栓塞（PE）的诊断颇具挑战，如果漏诊，可能导致患者发生潜在致命的复发性事件。除 CT 肺动脉造影（CTPA）和平面通气/灌注（V/Q）扫描外，单光子发射计算机断层扫描（SPECT）V/Q 成为一种新的放射性核素采集诊断方法，据报道可提高诊断性能。迄今为止，尚无基于 SPECT V/Q 的诊断 PE 算法的管理结局研究或随机试验。我们报告了一项随机、多中心、国际管理研究的设计，该研究比较了 SPECT V/Q 与经过验证的策略。
我们将总共纳入 3672 例疑似 PE 需行胸部影像学检查的患者，将其随机分为三组，每组采用不同的基于 SPECT V/Q、CTPA 和平面 V/Q 扫描的诊断策略。随机分组将不平衡（2:1:1），SPECT V/Q 组（n=1836）患者数量是 CTPA 和平面 V/Q 组（n=918）的两倍。我们的主要目标是确定基于 SPECT V/Q 的诊断策略在诊断排除安全性方面是否不劣于以前经过验证的策略，评估标准为阴性诊断检查的患者在 3 个月内发生血栓栓塞的风险。次要结局将是每个组中诊断为 PE 的患者比例、需要额外检查的患者比例、主要和临床相关非主要出血的发生率以及每个组中的死亡率和死因。
本试验由布雷斯特大学医院和 INVENT 资助。研究方案已获得生物医学伦理委员会的批准。在患者入组前，调查员或代表将获得所有患者签署的知情同意书。我们的研究结果将为未来的临床实践指南提供信息，并解决核医学指南和临床科学协会指南之间目前的差异。
NCT02983760。
