UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049693
Receipt number R000056601
Scientific Title Preoperative predictors of occult metastases in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Date of disclosure of the study information 2022/12/05
Last modified on 2022/12/05 15:10:07

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Basic information

Public title

Preoperative predictors of occult metastases in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma

Acronym

Predictors of occult metastases in R and BR PDAC

Scientific Title

Preoperative predictors of occult metastases in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma

Scientific Title:Acronym

Predictors of occult metastases in R and BR PDAC

Region

Japan


Condition

Condition

pancreatic ductal adenocarcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to identify preoperative predictors of occult metastases (OM), defined as distant metastases identified at surgery or within 6 months after pancreatectomy.

Basic objectives2

Others

Basic objectives -Others

Clarify the prognostic impact of OM

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Significant predictors of OM

Key secondary outcomes

Prognostic analysis by presence or absence of OM
Diagnostic accuracy of OM by predictors


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) Patients who were planned for radical pancreatectomy at Sapporo Medical University
2) Pathologically or cytologically proven diagnosis of PDAC
3) Patients with R and BR PDAC

Key exclusion criteria

1) Patients who underwent staging laparoscopy because of ascites or nodules suspected of peritoneal dissemination on MDCT
2) Patients with CA19-9 levels < 2 U/mL
3) Patients with < 6 months of follow-up despite the absence of OM

Target sample size

270


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Murakami

Organization

Sapporo Medical University

Division name

Department of Surgery, Surgical Oncology and Science

Zip code

0600061

Address

South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan

TEL

0116112111

Email

murakami.takeshi@sapmed.ac.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Murakami

Organization

Sapporo Medical University

Division name

Department of Surgery, Surgical Oncology and Science

Zip code

0600061

Address

South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan

TEL

0116112111

Homepage URL


Email

murakami.takeshi@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University
Department of Surgery, Surgical Oncology and Science

Institute

Department

Personal name



Funding Source

Organization

self funding

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

Sapporo Medical University Department of Surgery, Surgical Oncology and Science

Address

South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan

Tel

0116112111

Email

murakami.takeshii@sapmed.ac.jp


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

札幌医科大学病院(北海道)


Other administrative information

Date of disclosure of the study information

2022 Year 12 Month 05 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

279

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

No longer recruiting

Date of protocol fixation

2021 Year 02 Month 12 Day

Date of IRB

2021 Year 02 Month 12 Day

Anticipated trial start date

2021 Year 02 Month 12 Day

Last follow-up date

2022 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective observation study


Management information

Registered date

2022 Year 12 Month 05 Day

Last modified on

2022 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056601