UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019823
Receipt number 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 14:30:37

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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

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

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 or person

Institute

Cancer Institute Hospital

Institute

Department

Personal name



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

Value
https://center6.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

Single case data URL

Value
https://center6.umin.ac.jp/ice/22895