UMIN-CTR Clinical Trial

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

resectable pancreatic head cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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).

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Cancer Institute Hospital

Institute

Department

Personal name

Organization

Cancer Institute Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Partially published

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

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 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

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

Single case data URL

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