UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Implications of re-pancreatectomy for recurrence in the remnant pancreas after initial pancreatectomy for pancreatic ductal adenocarcinoma
Title of the study (Brief title)	Implications of re-pancreatectomy for recurrence in the remnant pancreas after initial pancreatectomy for pancreatic ductal adenocarcinoma
Region	Japan

Condition
Condition	Tumor in the remnant pancreas after surgery for pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the prognostic factor and implication of the re-pancreatectomy for the recurrent tumor in the remnant pancreas
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall survival after initial pancreatectomy
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	1. pathologically diagnosed pancreatic cancer 2. tumor in the remnant pancreas 3. all cases are included regardless the preoperative diagnosis 4. both resected cases and unresected cases 5. all resected cases are included regardless pathological diagnosis
Key exclusion criteria	1.only pancreatic ductal cancer in the pathological diagnosis of the initial pancreatectomy 2.metastasis of the other organs
Target sample size	200

Research contact person
Name of lead principal investigator	Tsutomu Fujii
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery (Surgery II)
Address	65,Tsurumai-cho,Showa-ku,Nagoya,Aichi, Japan
TEL	052-744-2245
Email	fjt@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tsutomu Fujii
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery (Surgery II)
Address	65,Tsurumai-cho,Showa-ku,Nagoya,Aichi, Japan
TEL	052-744-2245
Homepage URL
Email	fjt@med.nagoya-u.ac.jp

Sponsor
Institute	Japanese Society of Hepato-Biliary -Pancreatic Surgery
Institute
Department

Funding Source
Organization	Japanese Society of Hepato-Biliary -Pancreatic Surgery
Organization
Division
Category of Funding Organization	Other
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	名古屋大学医学部　医学系研究科　消化器外科学（愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 02 Month 10 Day
Anticipated trial start date	2015 Year 04 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	tumor in the remnant pancreas after surgery for pancreatic ductal cancer between January, 2001 and December 2014

Management information
Registered date	2016 Year 02 Month 11 Day
Last modified on	2018 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024210