UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018557
Receipt number R000021471
Scientific Title Analysis of the secretin stimulation for pancreatic juice cytology
Date of disclosure of the study information 2015/08/06
Last modified on 2016/02/08 10:44:52

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Basic information

Public title

Analysis of the secretin stimulation for pancreatic juice cytology

Acronym

Analysis of the secretin stimulation for pancreatic juice cytology

Scientific Title

Analysis of the secretin stimulation for pancreatic juice cytology

Scientific Title:Acronym

Analysis of the secretin stimulation for pancreatic juice cytology

Region

Japan


Condition

Condition

Pancreatic diseases

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to analyze whether the secretin stimulation, which enables to collet larger amount of pancreatic juice for cytology, improves the accuracy of pancreatic juice cytology or not.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The accuracy of pancreatic juice cytology

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

Medicine

Interventions/Control_1

Intravenous secretin administration
(1.2mcg/body at the time of ERP )

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) Aged 20 or more year-old
2) Patients who undergo ERP and pancreatic juice cytology for their pancreatic diseases
3) Written informed consent

Key exclusion criteria

1) Patients who have a history of severe complications due to ERP
2) Patients who have a history of complications due to secretin
3) Patients who have a history of drug allergy
4) Not written informed consent
5) Patients who the doctor-in-charge figures unsuitable for this study

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi Nakamura

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Surgery and Oncology

Zip code


Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan

TEL

092-642-5337

Email

mnaka@surg1.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshitaka Gotoh

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Surgery and Oncology

Zip code


Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan

TEL

092-642-5441

Homepage URL


Email

y-gotoh@surg1.med.kyushu-u.ac.jp


Sponsor or person

Institute

Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 08 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015 Year 04 Month 22 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 06 Day

Last modified on

2016 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021471


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name