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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023532
Receipt No. R000027102
Scientific Title Implications of curative pancreatectomy for pancreatic cancer with positive peritoneal washing cytology
Date of disclosure of the study information 2016/09/30
Last modified on 2018/02/07

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Basic information
Public title Implications of curative pancreatectomy for pancreatic cancer with positive peritoneal washing cytology
Acronym Implications of curative pancreatectomy for pancreatic cancer with positive peritoneal washing cytology
Scientific Title Implications of curative pancreatectomy for pancreatic cancer with positive peritoneal washing cytology
Scientific Title:Acronym Implications of curative pancreatectomy for pancreatic cancer with positive peritoneal washing cytology
Region
Japan

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

Objectives
Narrative objectives1 To assess the long- and short-term results in radical resection for pancreatic cancer with positive peritoneal washing cytology.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes disease-specific survival
Key secondary outcomes 1. disease-free survival
2. recurrence, initial recurrence pattern
3. surgical results (ope time, blood loss, blood transfusion, length of hospital stay)
4. postoperative complications (overall complications, re-laparotomy, re-adimission)
5. Mortality (30-days and 90-days mortality)
6. Pathological findings (pathological type, lymph node metastasis, TNM staging)

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 Patients who underwent peritoneal washing cytology and curative resection
Key exclusion criteria Patients who did not undergo peritoneal washing cytology
Target sample size 2500

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
Institute Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

Funding Source
Organization Japan Pancreas Society
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 30 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 Completed
Date of protocol fixation
2016 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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 We will use data of pancreatic cancer patients that were already registered with Registry of Pancreatic Cancer of the Japan Pancreas Society.

Management information
Registered date
2016 Year 08 Month 07 Day
Last modified on
2018 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027102

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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