臨床研究等提出・公開システム

Verification test on pancreatic cancer diagnosis by pancreatic juice cytology using synthetic secretin (S-PJC)

Efficacy and safety of pancreatic juice cytology by using
synthetic secretin in the diagnosis of pancreatic ductal
adenocarcinoma and IPMC (S-PJC)

Isomoto Hajime

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori Japan

isomoto@med.tottori-u.ac.jp

Sakamoto Yuri

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori Japan

+81-859-38-6527

yuri.sakamoto@mac.com

Recruiting

May. 01, 2011

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1. Patient provided informed consent at over 20 years old
2. Patients suspected of pancreatic cancer by image examination, or patients with IPMN which is classified as "high risk stigmata" or "worrisome features" by international consensus guidelines.

1) Patients with hypersensitivity to secretin or other ingredients (excipients: cysteine hydrochloride and Mannitol).
2) Patients within 2 weeks after remission from acute pancreatitis or acute exacerbations of chronic pancreatitis.
3) A pregnant or lactating woman.
4) Patients who received other research drugs or investigational drugs within 3 months prior to the start of administration of the study drug.
5) Patients whom the research responsible doctor judged inappropriate.

Both

Pancreatic cancer or IPMN

Administration of synthetic secretin

Diagnostic ability of the pancreatic juice cytology for pancreatic cancer after synthetic secreting loading (sensitivity, specificity, positive target rate, negative target rate, and accuracy)

1) Diagnostic ability of Exosome and cfDNA in pancreatic juice supernatant for pancreatic cancer (sensitivity, specificity, positive predictive value, negative predictive value and accuracy)
2) Diagnostic ability of MRI images of pancreatic cancer after synthetic secreting loading (sensitivity, specificity, positive predictive value, negative predictive value and accuracy)

+81-859-38-7021

Feb. 12, 2019

No

none