PDF(Pubmed)
Abstract：
BACKGROUND: Complete surgical removal of pancreatic ductal adenocarcinoma (PDAC) is central to all curative treatment approaches for this aggressive disease, yet this is only possible in patients technically amenable to resection. Hence, an accurate assessment of whether patients are suitable for surgery is of paramount importance. The SCANPatient trial aims to test whether implementing a structured synoptic radiological report results in increased institutional accuracy in defining surgical resectability of non-metastatic PDAC.
METHODS: SCANPatient is a batched, stepped wedge, comparative effectiveness, cluster randomised clinical trial. The trial will be conducted at 33 Australian hospitals all of which hold regular multi-disciplinary team meetings (MDMs) to discuss newly diagnosed patients with PDAC. Each site is required to manage a minimum of 20 patients per year (across all stages). Hospitals will be randomised to begin synoptic reporting within a batched, stepped wedge design. Initially all hospitals will continue to use their current reporting method; within each batch, after each 6-month period, a randomly selected group of hospitals will commence using the synoptic reports, until all hospitals are using synoptic reporting. Each hospital will provide data from patients who (i) are aged 18 or older; (ii) have suspected PDAC and have an abdominal CT scan, and (iii) are presented at a participating MDM. Non-metastatic patients will be documented as one of the following categories: (1) locally advanced and surgically unresectable; (2) borderline resectable; or (3) anatomically clearly resectable (Note: Metastatic disease is treated as a separate category). Data collection will last for 36 months in each batch, and a total of 2400 patients will be included.
CONCLUSIONS: Better classifying patients with non-metastatic PDAC as having tumours that are either clearly resectable, borderline or locally advanced and unresectable may improve patient outcomes by optimising care and treatment planning. The borderline resectable group are a small but important cohort in whom surgery with curative intent may be considered; however, inconsistencies with definitions and an understanding of resectability status means these patients are often incorrectly classified and hence overlooked for curative options.
BACKGROUND: The SCANPatient trial was registered on 17th May 2023 in the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12623000508673).
METHODS: SCANPatient is a batched, stepped wedge, comparative effectiveness, cluster randomised clinical trial. The trial will be conducted at 33 Australian hospitals all of which hold regular multi-disciplinary team meetings (MDMs) to discuss newly diagnosed patients with PDAC. Each site is required to manage a minimum of 20 patients per year (across all stages). Hospitals will be randomised to begin synoptic reporting within a batched, stepped wedge design. Initially all hospitals will continue to use their current reporting method; within each batch, after each 6-month period, a randomly selected group of hospitals will commence using the synoptic reports, until all hospitals are using synoptic reporting. Each hospital will provide data from patients who (i) are aged 18 or older; (ii) have suspected PDAC and have an abdominal CT scan, and (iii) are presented at a participating MDM. Non-metastatic patients will be documented as one of the following categories: (1) locally advanced and surgically unresectable; (2) borderline resectable; or (3) anatomically clearly resectable (Note: Metastatic disease is treated as a separate category). Data collection will last for 36 months in each batch, and a total of 2400 patients will be included.
CONCLUSIONS: Better classifying patients with non-metastatic PDAC as having tumours that are either clearly resectable, borderline or locally advanced and unresectable may improve patient outcomes by optimising care and treatment planning. The borderline resectable group are a small but important cohort in whom surgery with curative intent may be considered; however, inconsistencies with definitions and an understanding of resectability status means these patients are often incorrectly classified and hence overlooked for curative options.
BACKGROUND: The SCANPatient trial was registered on 17th May 2023 in the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12623000508673).
摘要：
背景：彻底手术切除胰腺导管腺癌（PDAC）对于这种侵袭性疾病的所有治愈性治疗方法至关重要，然而，这只有在技术上适合切除的患者才有可能。因此，准确评估患者是否适合手术至关重要。SCANPatient试验旨在测试实施结构化的天气放射学报告是否会提高机构定义非转移性PDAC手术可切除性的准确性。
方法：SCANPatient是成批的，阶梯式楔形物,比较有效性，整群随机临床试验。该试验将在33家澳大利亚医院进行，所有这些医院都定期举行多学科小组会议（MDMs），以讨论新诊断的PDAC患者。每个站点每年需要管理至少20名患者（在所有阶段）。医院将被随机分配，开始分批报告天气报告，阶梯式楔形设计。最初，所有医院将继续使用其目前的报告方法；在每个批次中，在每6个月之后，一组随机选择的医院将开始使用天气报告，直到所有医院都使用天气报告。每家医院将提供以下患者的数据：（i）18岁或以上；（ii）怀疑患有PDAC并进行腹部CT扫描，和(iii)在参与的MDM上介绍。非转移性患者将被记录为以下类别之一：（1）局部晚期和手术不可切除;（2）临界可切除;或（3）解剖学上清楚可切除（注意：转移性疾病作为单独的类别处理）。每批数据收集将持续36个月，共包括2400名患者。
结论：更好地将非转移性PDAC患者分类为具有明显可切除的肿瘤，边缘或局部晚期和不可切除可能会通过优化护理和治疗计划来改善患者的预后。临界可切除组是一个小而重要的队列，可以考虑进行具有治愈意图的手术；然而，与定义的不一致和对可切除状态的理解意味着这些患者通常被错误地分类,因此在治疗方案中被忽视.
背景：SCANPatient试验于2023年5月17日在澳大利亚新西兰临床试验注册中心（ANZCTR）（ACTRN12623000508673）注册。
方法：SCANPatient是成批的，阶梯式楔形物,比较有效性，整群随机临床试验。该试验将在33家澳大利亚医院进行，所有这些医院都定期举行多学科小组会议（MDMs），以讨论新诊断的PDAC患者。每个站点每年需要管理至少20名患者（在所有阶段）。医院将被随机分配，开始分批报告天气报告，阶梯式楔形设计。最初，所有医院将继续使用其目前的报告方法；在每个批次中，在每6个月之后，一组随机选择的医院将开始使用天气报告，直到所有医院都使用天气报告。每家医院将提供以下患者的数据：（i）18岁或以上；（ii）怀疑患有PDAC并进行腹部CT扫描，和(iii)在参与的MDM上介绍。非转移性患者将被记录为以下类别之一：（1）局部晚期和手术不可切除;（2）临界可切除;或（3）解剖学上清楚可切除（注意：转移性疾病作为单独的类别处理）。每批数据收集将持续36个月，共包括2400名患者。
结论：更好地将非转移性PDAC患者分类为具有明显可切除的肿瘤，边缘或局部晚期和不可切除可能会通过优化护理和治疗计划来改善患者的预后。临界可切除组是一个小而重要的队列，可以考虑进行具有治愈意图的手术；然而，与定义的不一致和对可切除状态的理解意味着这些患者通常被错误地分类,因此在治疗方案中被忽视.
背景：SCANPatient试验于2023年5月17日在澳大利亚新西兰临床试验注册中心（ANZCTR）（ACTRN12623000508673）注册。
