UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single arm clinical study of preoperative bile replacement for jaundiced patients : phase II traial to investigate the relationship to perioperative complication
Title of the study (Brief title)	Phase II study of preoperative bile replacement
Region	Japan

Condition
Condition	Biliary tract cancer and pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigate the effect of preoperative bile replacement for the patients with obstructive jaundice from the point of systemic and intestinal immunity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of postoperative infectious complications
Key secondary outcomes	Cellular immunity and intestinal integrity( Concanavalin A, Phytohemagglutin, Diamine oxydase activity)

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Performance Status 0-1 Patients over 20 years of age to 80 years Patients with Pancreas or biliary tract cancer without multiple organ failure. Patients with serum total bilirubin levels greater than 3.0mg/dl.
Key exclusion criteria	Patients who do not agree with this study. Patients with cirrhosis or active hepatitis. Patients with severe cardiac or respiratory disease. Patients who receive hemodialysis. Patients with pregnant. Patients with cancer in other organs. Patients who were deemed inappropriate by the attending physician.
Target sample size	40

Research contact person
Name of lead principal investigator	Tetsuo Ajiki
Organization	Kobe university hospital
Division name	Hepato biliary pancreatic surgery
Address	7-5-2 Kusunoki-cho, Chuouku Kobe-city
TEL	078-382-6302
Email	ajiki@med.kobe-u.ac.jp

Public contact
Name of contact person	Tetsuo Ajiki
Organization	Kobe university hospital
Division name	Hepato biliary pancreatic surgery
Address	7-5-2 K7-5-2 Kusunoki-cho, Chuouku Kobe-city
TEL	078-382-6302
Homepage URL
Email	ajiki@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university
Institute
Department

Funding Source
Organization	Kobe university division of Hepato-biliary-pancreatic surgery
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	神戸大学附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2018 Year 12 Month 28 Day
Date of closure to data entry	2018 Year 12 Month 28 Day
Date trial data considered complete	2018 Year 12 Month 28 Day
Date analysis concluded	2019 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	1.Bile replacement; First, external biliary drainage(ENBD or PTBD) is performed as treatment of obstructive jaundice. Then, at least200ml of bile which is collected on the day before is taken orally for over 14 days. 2.Examination item; Evaluation of the systemic immune function; concanavalin A, phytohemagglutinin. Evaluation of intestinal integrity; serum diamine oxidase activity. Evaluation of coagulate function; prothrombin time, activated partial thromboplastin time. Evaluation of liver function; serum total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transpeptidase, cholinesterase. Other items; volume of the drained bile, bilirubin concentration in the bile. 3.Postoperative surgical site infection; The diagnosis is made according to the CDC guideline.

Management information
Registered date	2014 Year 08 Month 11 Day
Last modified on	2019 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017112