UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase 2 study of choledochojejunostomy in pagients with locally advanced pancreatic adenocarcinoma undergoing chemo-proton therapy.
Title of the study (Brief title)	Choledochojejunostomy for pancreatic adenocarcinoma undergoing chemo-proton therapy.
Region	Japan

Condition
Condition	locally advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of choledochojejunostomy in patients with locally advanced pancreatic adenocarcinoma who are undergoing chemo-proton therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of unplanned delay or discontinuation of proton therapy
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Choledochojejunostomy before chemo-proton therapy
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	1. Locally advanced pancreatic cancer 2. Malignant bile duct ostruction 3. Pathologically confirmed adenocarcinoma / adenosquamous carcinoma 4. Age: >=20,80< 5. Aerformance Status (ECOG) 0/1 6. Sufficient function of important organs 7. Written informed consent
Key exclusion criteria	1. Past history of choledochojejunostomy 2. History of diseases which cause bile duct stenosis 3. Past history of abdominal irradiation 4. Inability of solid oral intake 5. Uncontrollable diabetes mellitus 6. Sever complication(heart failure, renal failure,liver failure,intestinal paralysis etc) 7. Acute coronary syndrome within 6 months, severe arrythmia 8. Consistent steroid use 9. Severe mental disorder 10. doctors decision not to be registered to this study
Target sample size	50

Research contact person
Name of lead principal investigator	Hirochika Toyama
Organization	Kobe University
Division name	Division of Hepato-biliary-pancreatic Surgery Department of Surgery
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-6302
Email	tymhr@me.com

Public contact
Name of contact person	Hirochika Toyama
Organization	Kobe University Graduate School of Medicine
Division name	Division of Hepato-biliary-pancreatic Surgery Department of Surgery
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-6302
Homepage URL
Email	tymhr@me.com

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Self funding
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	2018 Year 01 Month 24 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 19 Day
Anticipated trial start date	2018 Year 03 Month 01 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	2018 Year 01 Month 23 Day
Last modified on	2018 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035352