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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013208
Receipt No. R000015408
Scientific Title Safety and efficacy of early drain removal and triple-drug therapy to prevent pancreatic fistula after distal pancreatectomy: A prospective study at a single institute
Date of disclosure of the study information 2014/02/21
Last modified on 2014/02/21

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Basic information
Public title
Safety and efficacy of early drain removal and triple-drug therapy to prevent pancreatic fistula after distal pancreatectomy: A prospective study at a single institute
Acronym
Safety and efficacy of early drain removal and triple-drug therapy to prevent pancreatic fistula after distal pancreatectomy: A prospective study at a single institute
Scientific Title
Safety and efficacy of early drain removal and triple-drug therapy to prevent pancreatic fistula after distal pancreatectomy: A prospective study at a single institute
Scientific Title:Acronym
Safety and efficacy of early drain removal and triple-drug therapy to prevent pancreatic fistula after distal pancreatectomy: A prospective study at a single institute
Region
Japan

Condition
Condition distal pancreatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the safety and efficacy of early drain removal and triple-drug therapy (TDT) with gabexate mesilate, octreotide and carbapenem antibiotics to prevent pancreatic fistula after distal pancreatcomy in patients at high-risk of developing pancraetic fistula.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and efficacy of this management
Key secondary outcomes Incidence of pancreatic fistula.

Base
Study type

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Drain was removed on postoperative day1. For the patients with a high drain amylase level and patients with symptomatic intraperitoneal fluid collection, triple-drug therapy was introduced.
Interventions/Control_2 Drain remained in place for at least for 5 days postoperatively
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 who were performed distal pancreatetcomy
Key exclusion criteria Combined with other-organ resection and postoperative intraperitoneal bleeding via the drain on the day of surgery
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiko Adachi
Organization Nagasaki university
Division name Department of surgery
Zip code
Address 1-7-1, Sakamoto, Nagasaki
TEL 095-819-7316
Email adatomo@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiko Adachi
Organization Nagasaki university
Division name Department of surgery
Zip code
Address 1-7-1, Sakamoto, Nagasaki
TEL 095-819-7316
Homepage URL
Email adatomo@nagasaki-u.ac.jp

Sponsor
Institute Department of surgery, Nagasaki univ.
Institute
Department

Funding Source
Organization none
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
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
2014 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2005 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 06 Month 01 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
2014 Year 02 Month 21 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015408

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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