UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility of biliary plastic stent for bile duct obstruction with pancreatic cancer during neoadjuvant chemoradiotherapy
Title of the study (Brief title)	Feasibility of biliary plastic stent for bile duct obstruction with pancreatic cancer during neoadjuvant chemoradiotherapy
Region	Japan

Condition
Condition	Pancreatic head cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the impact of the difference between PS and MS on clinical course of NACRT, surgery and economic impact.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the impact of difference between biliary stents on the period of NACRT and completion of NACRT.
Key secondary outcomes	duration of stent patency during NACRT, reintervention rate during NACRT, total number of reintervention during NACRT, hospital stay for reintervention during NACRT, R0 resection, surgical procedure, intraoperative characteristics, postoperative complications, mortality and hospital stays.the economic impact of maintaining preoperative biliary drainage with biliary stent.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with pancreatic head cancer who were performed biliary drainage with biliary plastic stent or metallic stent alone during neoadjuvant chemoradiothrapy, and underwent pancreatoduodenectomy or total pancreatectomy in the Department of Surgery at Nara Medical University between January 2008 and January 2017.
Key exclusion criteria	The patients who were treated with only neoadjuvant chemotherapy without radiation therapy. The patients who were treated with adjuvant surgery after primary chemotherapy for locally advanced pancreatic cancer. The patients who were treated by main biliary stent with endoscopic nasobiliary drainage (ENBD) or percutaneous drainage together at beginning of NACRT
Target sample size	50

Research contact person
Name of lead principal investigator	Kota Nakamura
Organization	Nara Medical University
Division name	Department of Surgery
Address	840 Shijo-cho, Kashihara, Nara, JAPAN
TEL	0744-22-3051
Email	knaka@naramed-u.ac.jp

Public contact
Name of contact person	Kota Nakamura
Organization	Nara Medical University
Division name	Department of Surgery
Address	840 Shijo-cho, Kashihara, Nara, JAPAN
TEL	0744-22-3051
Homepage URL
Email	knaka@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
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	2017 Year 06 Month 25 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 15 Day
Anticipated trial start date	2017 Year 01 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	There are neither duration of intervention nor observation in this study because this study is retrospective study in which the data of patients who underwent pancreatectomy are picked up from medical records.

Management information
Registered date	2017 Year 06 Month 25 Day
Last modified on	2017 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030938