UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022280
Receipt number R000025674
Scientific Title Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.
Date of disclosure of the study information 2016/05/11
Last modified on 2016/05/11 18:20:46

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Basic information

Public title

Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.

Acronym

Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.

Scientific Title

Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.

Scientific Title:Acronym

Validity of semicircumferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.

Region

Japan


Condition

Condition

resectable or borderline resectable pancreatic head cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the validity of semicircimferencial dissection of superior mesenteric plexus in pancreatic head cancer based on the preoperative diagnosis of extrapancreatic plexus invasion by MDCT.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

R0 resection rate

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) resectable or borderline resectable pancreatic head cancer
2) Histologically proven pancreatic adenocarcinoma
3) more than 20 years old
4) ECOD performance status 0-1
5) written informed concent

Key exclusion criteria

1) the cases of taboo for MDCT
2) the cases with severe comorbidity
3) bad general condition
4) active double cancer
5) inappropriate cases

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiko Tsuchida

Organization

Tokyo Medical University

Division name

Gastrointestinal and Pediatric Surgery

Zip code


Address

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Email

yatsukasahara@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Nagakawa

Organization

Tokyo Medical University

Division name

Gastrointestinal and Pediatric Surgery

Zip code


Address

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Homepage URL


Email

yatsukasahara@yahoo.co.jp


Sponsor or person

Institute

Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University

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 05 Month 11 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

Preinitiation

Date of protocol fixation

2015 Year 02 Month 13 Day

Date of IRB


Anticipated trial start date

2015 Year 06 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

none


Management information

Registered date

2016 Year 05 Month 11 Day

Last modified on

2016 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025674


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name