NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051200117

Registered date:22/01/2021

Development of a screening test for pancreatic cancer by gastrointestinal endoscopy using synthetic human secretin and a specially-made catheter

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studied1. Pancreatic cancer or suspected pancreatic cancer 2. Neither pancreatic cancer nor other cancers
Date of first enrollment27/07/2021
Target sample size150
Countries of recruitment
Study typeInterventional
Intervention(s)Synthetic secretin 0.2 mcg/kg is injected intravenously prior to gastrointestinal endoscopy over 1 minute and a specially-made catheter is used to collect duodenal juice following conventional gastrointestinal endoscopy.

Outcome(s)

Primary OutcomeSensitivity and specificity of pancreatic cancer diagnosis
Secondary OutcomeVolume of the collected duodenal juice Adverse events within next day after administration of the study drug

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patient-provided informed consent and over 20 years old 2. Patients with pancreatic cancer or suspected of pancreatic cancer (N=100) and Participants without pancreatic cancer or other cancers (N=50) (Planned endoscopy) 3. Persons who have given their written consent to participate in this research
Exclude criteria1) Patients with hypersensitivity to secretin or other ingredients (excipients: cysteine hydrochloride and mannitol) 2) Patients in remission from acute pancreatitis or acute exacerbations of chronic pancreatitis within 2 weeks of the start of administration of the study drug 3) Patients who don't discontinue anticholinergic drugs at least 5 half-lives prior to the start of administration of the study drug 4) Pregnant or lactating women 5) Patients who received other research drugs or investigational drugs within 3 months of the start of administration of the study drug 6) Patients whom the doctor in charge judges inappropriate

Related Information

Contact

Public contact
Name Hidenori Tanaka
Address 2-2 Yamadaoka, Suita, Osaka, Japan Osaka Japan 565-0871
Telephone +81-6-6879-3360
E-mail htanaka@ent.med.osaka-u.ac.jp
Affiliation Graduate School of Medicine, Osaka University
Scientific contact
Name Shinichi Yachida
Address 2-15 Yamadaoka, Suita, Osaka, Japan Osaka Japan 565-0871
Telephone +81-6-6879-5111
E-mail syachida@cgi.med.osaka-u.ac.jp
Affiliation Osaka University Hospital