UMIN-CTR Clinical Trial

Basic information
Public title	A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy
Acronym	A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy
Scientific Title	A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy
Scientific Title:Acronym	A clinical trial of a new criteria for drain removal after pancreaticoduodenectomy
Region	Japan

Condition
Condition	Periampullary diseases
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To apply the new criteria for drain removal after pancreaticoduodenectomy in order to decrease the rate of pancreatic fistula and to decrease the rate of interventional drainage or relaparotomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of pancreatic fistula (Grade B or C)
Key secondary outcomes	BMI, comorbidity, preoperative steroids, operation time, intraoperative blood loss, years of experience of surgeons, pancreatic parencyma, rate of pancreatic fistula(Grade A), rate of bleeding after surgery, rate of intraperitoneal abscess, rate of interventional drainage, rate of relaparotomy, rate of DGE, postoperative pancreatitis, postoperative cholangitis, SSI, rate of morbidity, length of drain insertion, hospital stay, mortality, rate of readmission

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	New criteria for drain removal
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients received pancreaticoduodenectomy for periampullary diseases
Key exclusion criteria	Patients with severe comorbidity Patients with dysfunction of vital organs
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichi Taniguchi
Organization	Yokohama City University
Division name	Department of Gastroenterological Surgery
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama city
TEL	045-787-2650
Email	t1006koichi@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Koichi Taniguchi
Organization	Yokohama City University
Division name	Department of Gastroenterological Surgery
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama city
TEL	045-787-2650
Homepage URL
Email	t1006koichi@yahoo.co.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	None
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
Address
Tel
Email

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	2015 Year 03 Month 22 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	Open public recruiting
Date of protocol fixation	2012 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date	2012 Year 04 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 22 Day
Last modified on	2015 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019574

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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