Background and Aims

Pancreatic cancer organoids are tumor models of individualized human pancreatic ductal adenocarcinoma (PDA), created from surgical specimens and used for personalized treatment strategies. Unfortunately, most patients with PDA are not operative candidates. Creation of human PDA organoids at the time of initial tumor diagnosis is therefore critical. Our aim was to assess the feasibility of creating human PDA organoids by EUS fine-needle biopsy (EUS-FNB) sampling in patients with PDA.

Methods

In this prospective clinical trial in patients referred to evaluate a pancreatic mass, EUS-FNA was performed for initial onsite diagnosis. Two additional needle passes were performed with a 22-gauge FNB needle for organoid creation. Primary outcome was successful isolation of organoids within 2 weeks of EUS-FNB sampling (P0, no passages), confirmed by organoid morphology and positive genotyping.

Results

Thirty-seven patients with 38 PDA tumors were enrolled. Successful isolation of organoids (P0) was achieved in 33 of 38 tumors (87%). Establishment of PDA organoid lines for ≥5 passages of growth (P5, five passages) was reached in 25 of 38 tumors (66%). In the single patient with successful P5 FNB sampling–derived and P5 surgically derived organoids, there was identical matching of specimens. There were no serious adverse events. Two patients developed bleeding at the EUS-FNB puncture site requiring hemostasis clips.

Conclusions

Pancreatic cancer organoids can be successfully and rapidly created by means of EUS-FNB sampling using a 22-gauge needle at the time of initial diagnosis. Successful organoid generation is essential for precision medicine in patients with pancreatic cancer in whom most are not surgically resectable. (Clinical trial registration number: NCT03140592.)

中文翻译：

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通过EUS指导的细针穿刺活检采样成功创建胰腺癌类器官，用于个性化癌症治疗

背景和目标

胰腺癌类器官是由手术标本创建的个性化人类胰腺导管腺癌（PDA）的肿瘤模型，可用于个性化治疗策略。不幸的是，大多数患有PDA的患者都不适合手术。因此，在最初的肿瘤诊断时创建人PDA类器官至关重要。我们的目的是评估通过EUS细针穿刺活检（EUS-FNB）采样在PDA患者中创建人PDA类器官的可行性。

方法

在这项针对评估胰腺肿块的患者的前瞻性临床试验中，EUS-FNA用于初步现场诊断。使用22口径FNB针进行了另外两次针刺操作，以创建类器官。主要结果是在EUS-FNB采样后的2周内成功分离出类器官（P0，无传代），这已通过类器官形态学和阳性基因分型得到证实。

结果

纳入了38例PDA肿瘤的37例患者。在38个肿瘤中，有33个肿瘤（87％）成功分离出类器官（P0）。在38个肿瘤中，有25个肿瘤（66％）建立了≥5个传代（P5，五个传代）的PDA类器官系。在成功获得P5 FNB采样和P5手术来源类器官的单例患者中，标本完全相同。没有严重的不良事件。两名患者在EUS-FNB穿刺部位出血，需要使用止血夹。

结论

在初诊时，可以通过使用22号针头进行EUS-FNB采样来成功，快速地创建胰腺癌类器官。对于大多数无法手术切除的胰腺癌患者，成功的类器官产生对于精准医学至关重要。（临床试验注册号：NCT03140592。）