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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019823
Receipt No. R000022895
Scientific Title Diagnostic accuracy of preoperative multidetector-row computed tomography comparing with 3D pathological examination predicting curative resection of pancreatic cancer: a prospective study
Date of disclosure of the study information 2015/11/20
Last modified on 2017/05/19

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Basic information
Public title Diagnostic accuracy of preoperative multidetector-row computed tomography comparing with 3D pathological examination predicting curative resection of pancreatic cancer: a prospective study
Acronym Diagnostic accuracy of preoperative multidetector-row computed tomography comparing with 3D pathological examination predicting curative resection of pancreatic cancer: a prospective study
Scientific Title Diagnostic accuracy of preoperative multidetector-row computed tomography comparing with 3D pathological examination predicting curative resection of pancreatic cancer: a prospective study
Scientific Title:Acronym Diagnostic accuracy of preoperative multidetector-row computed tomography comparing with 3D pathological examination predicting curative resection of pancreatic cancer: a prospective study
Region
Japan

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

Objectives
Narrative objectives1 assessment of difference between preoperative MD-CT findings snd 3D pathological findings for pancreatic head cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes We compare MD-CT findings with pathological findings to y categorize the degree of cancer invasion to plexus, and calculate the sensitivity and specificity.
Key secondary outcomes We calculate the sensitivity and specificity about cure resection, and about relationship between portal vein and tumor (abutment unilateral impingement, bilateral impingement, and occlusion).

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) the cases pancreaticoduodenectomy with portal vein resection for pancreatic head cancer
2) resectable pancreatic head cancer without distant metastasis
3) regardless of biliary drainage
4) regardless of neoadjuvant chemoradiotherapy
5) we take CT within one month
6) the cases with operative conditions
7) the cases with consent
Key exclusion criteria 1) the cases of taboo for MD-CT
2) the unresectable pancreatic head cancer with distant metastasis
3) the cases with happenings
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Akio Saiura
Organization Cancer Institute Hospital
Division name Hepato-Biliary-Pancreatic Surgery
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo
TEL 03-3520-0111
Email akio.saiura@jfcr.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masayuki Tanaka
Organization Cancer Institute Hospital
Division name Hepato-Biliary-Pancreatic Surgery
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo
TEL 03-3520-0111
Homepage URL
Email masa_psg@hotmail.com

Sponsor
Institute Cancer Institute Hospital
Institute
Department

Funding Source
Organization Cancer Institute Hospital
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2015 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is prospective non-interventional study.

IN our institute, we have 50 cases of pancreaticoduodenectomy with portal vein resection for pancreatic head cancer, therefore, 30 cases will be suitable for this study.

The period of this study is Between 12/1/2015 and 11/30/2016

Evaluation: the distance between tumor and SMA, and tumor and portal vein

Management information
Registered date
2015 Year 11 Month 17 Day
Last modified on
2017 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022895

Research Plan
Registered date File name
2017/05/19 臨床試験201501128.docx

Research case data specifications
Registered date File name
2017/05/19 最終データまとめ.xlsx

Research case data
Registered date File name
2017/05/19 解析結果.xlsx


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