UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cytologic diagnostic ability of pancreatic juice obtained by naso-pancreatic catheter in patients with stenosis and/or dilatation of main pancreatic duct
Title of the study (Brief title)	Cytologic diagnostic ability of pancreatic juice obtained by naso-pancreatic catheter
Region	Japan

Condition
Condition	Patients with suspected pancreatic cancer because of dilatation/stenosis of main pancreatic duct
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate cytological diagnostic ability for pancreatic cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy of pancreatic juice cytology obtained via naso-pancreatic catheter
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Obtaining pancreatic juice using naso-pancreatic catheter
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Newly diagnosed dilatation/stenosis of main pancreatic duct onn Dynamic CT, MRI, or EUS 2. No detection of pancreatic mass which can be performed EUS-FNA 3. Pancreatic mass which could not be definitive diagnosed even in use of EUS-FNA 4. Ability to understand and willingness to sign a written statement of informed consent
Key exclusion criteria	1. Surgically altered upper gastrointestinal anatomy except for Billroth I 2. Coexistence of acute pancreatitis 3. Diffilulty of deep insertion of naso-pancreatic catheter owing to pancreatic divisim or loop formation of main pancreatic duct 4. Bleeding tendency 5. ASA >=3 6. ECOG PS >=4 7. Pregnant or possibly pregnant women 8. I-1 or more of Japan Coma Scale (JCS) 9. Any disorder that compromised the patient's ability to provide written informed consent and/or comply with the study procedure
Target sample size	20

Research contact person
Name of lead principal investigator	Tsuyoshi Hayashi
Organization	Teine Keijinkai Hospital
Division name	Center for Gastroenterology
Address	1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
TEL	011-681-8111
Email	thayashi244@gmail.com

Public contact
Name of contact person	Tsuyoshi Hayashi
Organization	Teine Keijinkai Hospital
Division name	Center for Gastroenterology
Address	1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
TEL	011-681-8111
Homepage URL
Email	thayashi244@gmail.com

Sponsor
Institute	Center for Gastroenterology, Teine Keijinkai Hospital
Institute
Department

Funding Source
Organization	Center for Gastroenterology, Teine Keijinkai Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 18 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 02 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 02 Month 17 Day
Last modified on	2019 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040898