UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of pancreatic endocrine and exocrine function with measuring pancreatic fibrosis(hardness) in patients with postoperative pancreatic resection.
Title of the study (Brief title)	Evaluation of pancreatic function with ARFI elastography in patients with postoperative pancreatic resection.
Region	Japan

Condition
Condition	Patients after pancreatic resection.
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of measuring pancreatic hardness postoperatively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The correlation between pancreatic function and ARFI elastography.
Key secondary outcomes	The efficacy of ARFI elastograpy as prediction of pancreatic dysfunction after pancreatic resection.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients after pancreatic resection
Key exclusion criteria	Patients without informed consent
Target sample size	100

Research contact person
Name of lead principal investigator	Kitago Minoru
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL	03-3353-1211(ext62529)
Email	contact@keio-hbpts.jp

Public contact
Name of contact person	Kitago Minoru
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL	03-3353-1211(ext62529)
Homepage URL
Email	contact@keio-hbpts.jp

Sponsor
Institute	Department of Surgery, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery, Keio University School of Medicine
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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 15 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	No appreciable matter.

Management information
Registered date	2014 Year 12 Month 11 Day
Last modified on	2018 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018478