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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045604
Receipt No. R000052068
Scientific Title Patient characteristics and intraoperative factors predicting clinical relevant pancreatic fistula after pancreaticoduodenectomy
Date of disclosure of the study information 2021/10/01
Last modified on 2021/09/29

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Basic information
Public title Patient characteristics and intraoperative factors predicting clinical relevant pancreatic fistula after pancreaticoduodenectomy
Acronym Pancreatic fistula after pancreaticoduodenectomy
Scientific Title Patient characteristics and intraoperative factors predicting clinical relevant pancreatic fistula after pancreaticoduodenectomy
Scientific Title:Acronym Pancreatic fistula after pancreaticoduodenectomy
Region
Japan

Condition
Condition Pancreaticoduodenectomy
Classification by specialty
Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Pancreatic fistula (PF) remains the most important cause of morbidity and mortality following pancreaticoduodenectomy (PD). Several studies have identified surgical risk factors associated with clinical relevant PF (Grade B or C) but few studies have focused on anesthetic aspects.
Basic objectives2 Others
Basic objectives -Others The aim of the study is to validate predictive patient characteristics and intraoperative factors including depth of anesthesia of clinical relevant PF after PD.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Depth of anesthesia (bispectral index)
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
90 years-old >
Gender Male and Female
Key inclusion criteria elective open pancreaticoduodenectomy
Key exclusion criteria dialysis-dependent patients, patients with missing intraoperative data
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Nakasuji
Organization Kansai Electric Power Hospital
Division name Department of Anesthesiology
Zip code 5530003
Address 2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
TEL 06-6458-5821
Email nakasuji.masato@c3.kepco.co.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Nakasuji
Organization Kansai Electric Power Hospital
Division name Department of Anesthesiology
Zip code 5530003
Address 2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
TEL 06-6458-5821
Homepage URL
Email nakasuji.masato@c3.kepco.co.jp

Sponsor
Institute Kansai Electric Power Hospital
Institute
Department

Funding Source
Organization Kansai Electric Power Hospital
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 Institutional Review Board of Kansai Electric Power Hospital
Address 2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
Tel 06-6458-5821
Email koga.kazuhiro@c3.kepco.co.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
2021 Year 10 Month 01 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
2021 Year 09 Month 01 Day
Date of IRB
2021 Year 09 Month 15 Day
Anticipated trial start date
2021 Year 10 Month 01 Day
Last follow-up date
2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this case-control retrospective study based on the past anesthetic records, patients undergoing elective open PD from September 2013 to April 2021 were divided into PF (Grade B or C) and non-PF (without PF or asymptomatic PF of Grade A) groups. We compared perioperative factors between the two groups and logistic analysis was used to identify the independent risk factors of PF.

Management information
Registered date
2021 Year 09 Month 29 Day
Last modified on
2021 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052068

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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