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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036425
Receipt No. 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

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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
Institute Nagoya University
Institute
Department

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
URL(English) https://upload.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


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