UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020978
Receipt number R000024210
Scientific Title Implications of re-pancreatectomy for recurrence in the remnant pancreas after initial pancreatectomy for pancreatic ductal adenocarcinoma
Date of disclosure of the study information 2016/03/01
Last modified on 2018/07/25 14:53:46

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Basic information

Public title

Implications of re-pancreatectomy for recurrence in the remnant pancreas after initial pancreatectomy for pancreatic ductal adenocarcinoma

Acronym

Implications of re-pancreatectomy for recurrence in the remnant pancreas after initial pancreatectomy for pancreatic ductal adenocarcinoma

Scientific Title

Implications of re-pancreatectomy for recurrence in the remnant pancreas after initial pancreatectomy for pancreatic ductal adenocarcinoma

Scientific Title:Acronym

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

1st name
Middle name
Last name Tsutomu Fujii

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery (Surgery II)

Zip code


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

1st name
Middle name
Last name Tsutomu Fujii

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery (Surgery II)

Zip code


Address

65,Tsurumai-cho,Showa-ku,Nagoya,Aichi, Japan

TEL

052-744-2245

Homepage URL


Email

fjt@med.nagoya-u.ac.jp


Sponsor or person

Institute

Japanese Society of Hepato-Biliary -Pancreatic Surgery

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 02 Month 10 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024210


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name