Efficacy and safety of pancreatic juice cytology by using synthetic secretin in the diagnosis of pancreatic ductal adenocarcinoma and IPMC

JRCT ID: jRCTs061180043

Registered date:08/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer or IPMN
• Date of first enrollment: 10/05/2011
• Target sample size: 420
• Study type: Interventional
• Intervention(s): Administration of synthetic secretin

Outcome(s)

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

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Isomoto Hajime
• Secondary ID(s): UMIN000031492