UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Efficacy of Serum Procalcitonin Measurements in the Clinical Management of Acute Cholangitis
Title of the study (Brief title)	Efficacy of Procalcitonin in the Clinical Management of Acute Cholangitis
Region	Japan

Condition
Condition	Patients with cholestasis
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the efficacy of serum procalcitonin measurements in diagnosis and severity assessment of acute cholangitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. To set up the cut-off value of serum procalcitonin level in the diagnosis of acute cholangitis 2. To set up the cut-off value of serum procalcitonin level in the severitiy assessment of acute cholangitis
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with cholestasis due to choledocholithiasis, pancreato-biliary malignancy, and benign bile duct stricture
Key exclusion criteria	Patients with acute cholecystitis, hepatic abscess, acute pancreatitis, recurrence of cancer, liver cirrhosis, chronic kidney disease, and chronic obstructive pulmonary disease and patients receiving long term steroid treatment
Target sample size	200

Research contact person
Name of lead principal investigator	Fumihiko Miura
Organization	Teikyo University School of Medicine
Division name	Department of Surgery
Address	2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
Email

Public contact
Name of contact person	Fumihiko Miura
Organization	Teikyo University School of Medicine
Division name	Department of Surgery
Address	2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Sceience and Technology
Organization
Division
Category of Funding Organization
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	2012 Year 08 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 25 Day
Anticipated trial start date	2012 Year 08 Month 06 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	Prospective observation study

Management information
Registered date	2012 Year 08 Month 04 Day
Last modified on	2017 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010130