UMIN-CTR Clinical Trial

Basic information
Public title	Risk Factors for Surgical site infection After Pancreatectomy and the Associated Pathogens; a Retrospective Case-controlled Study
Acronym	Pathogens Examination From Drainage Fluid After Pancreatectomy
Scientific Title	Risk Factors for Surgical site infection After Pancreatectomy and the Associated Pathogens; a Retrospective Case-controlled Study
Scientific Title:Acronym	Pathogens Examination From Drainage Fluid After Pancreatectomy
Region	Japan

Condition
Condition	Pancreatectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to assess the risk factors for postoperative pancreatic fistula, to identify pathogen profiles cultured from postoperative drainage fluids, and to evaluate the predictability of high-risk pathogens for severe complications.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the incidence of clinically relevant postoperative pancreatic fistula
Key secondary outcomes	the types and the frequencies of microorganisms as related to the severity of the clinically relevant postoperative pancreatic fistula

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	patients who underwent pancreaticoduodenectomy or distal pancreatectomy
Key exclusion criteria	patients who underwent total pancreatectomy or partial pancreatic resection
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Minoru Middle name Last name Kitago
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	1608582
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-5363-3802
Email	dragonpegasus@keio.jp

Public contact
Name of contact person	1st name Kodai Middle name Last name Abe
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	1608582
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-5363-3802
Homepage URL
Email	abe.kodai@gmail.com

Sponsor
Institute	Keio University School of Medicine, Department of Surgery
Institute
Department

Funding Source
Organization	Keio University School of Medicine, Department of Surgery
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	Keio University School of Medicine, An Ethics Committee
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
Tel	+81-3-5363-3611
Email	med-rinri-jimu@adst.keio.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	2020 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	429
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	2019 Year 04 Month 10 Day
Date of IRB	2012 Year 04 Month 03 Day
Anticipated trial start date	2019 Year 05 Month 10 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective case-controlled study

Management information
Registered date	2020 Year 06 Month 15 Day
Last modified on	2020 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046565