UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036425
Receipt number R000041504
Scientific Title Preoperative predictors of intraoperative major blood loss in patients undergoing pancreatoduodenectomy
Date of disclosure of the study information 2019/04/05
Last modified on 2020/08/04 01:22:25

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Basic information

Public title

Predictors of intraoperative major blood loss in patients undergoing pancreatoduodenectomy

Acronym

Predictors of intraoperative major blood loss during PD

Scientific Title

Preoperative predictors of intraoperative major blood loss in patients undergoing pancreatoduodenectomy

Scientific Title:Acronym

Preoperative predictors of intraoperative major blood loss during PD

Region

Japan


Condition

Condition

Patients undergoing pancreatooduodenectoomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To identify the significant preoperative predictors of major blood loss during pancreatoduodenectomy

Basic objectives2

Others

Basic objectives -Others

To identify predictors

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Intraoperative blood loss during pancreatoduodenectomy

Key secondary outcomes

ratio of net blood loss to estimated circulating blood volume


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

Patients undergoing planned pancreatoduodenectomy

Key exclusion criteria

Patients undergoing emergent procedures
Patients undergoing additional procedures in other organ (e.g., hepatectomy, resection of gynecological organs, etc.)

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Masato
Middle name
Last name Nagino

Organization

Nagoya University Graduate School of Medicine

Division name

Surgical Oncology

Zip code

466-8560

Address

65 Tsurumai-cho Showa-ku Nagoya Aichi Japan

TEL

052-744-2222

Email

nagino@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Yukihiro
Middle name
Last name Yokoyama

Organization

Nagoya University Graduate School of Medicine

Division name

Surgical Oncology

Zip code

466-8560

Address

65 Tsurumai-cho Showa-ku Nagoya Aichi Japan

TEL

052-744-2222

Homepage URL


Email

yyoko@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

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

Ethics Committee of Nagoya University Graduate School of Medicine

Address

65 Tsurumai-cho Showa-ku Nagoya Aichi Japan

Tel

052-744-2973

Email

ethics@med.nagoya-u.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



Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 05 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s00595-020-02054-y

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s00595-020-02054-y

Number of participants that the trial has enrolled

415

Results

The PMD (coefficient - 0.267; 95% CI - 0.518, - 0.015), VSR (coefficient 2.719; 95% CI 0.238, 5.201), serum albumin level (coefficient - 8.458; 95% CI - 13.02, - 3.898), neoadjuvant therapy (coefficient 9.605; 95% CI 1.722, 17.49), and prothrombin time-international normalized ratio (PT-INR, coefficient 38.63; 95% CI 10.94, 66.31) were independently associated with PBL.

Results date posted

2019 Year 04 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 06 Month 20 Day

Baseline Characteristics

The median age was 69 years, and 280 (67.5%) patients were male.

Participant flow

Among the 436 patients who underwent PD from January 2008 to December 2019, 21 patients were excluded: four patients underwent emergency procedures, and 17 patients underwent additional procedures. The data of the remaining 415 patients were used for the analysis.

Adverse events

None

Outcome measures

The proportion of blood loss during PD to estimated circulating blood volume

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 10 Month 26 Day

Date of IRB

2018 Year 12 Month 20 Day

Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2020 Year 05 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The data of consecutive patients undergoing PD between January 2008 and December 2019 were retrospectively reviewed. We identify significant preoperative predictors of major blood loss during PD.


Management information

Registered date

2019 Year 04 Month 05 Day

Last modified on

2020 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041504


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name