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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023542
Receipt No. R000027078
Scientific Title study of milk test as a preventive method for chylous ascites following pancreatectomy
Date of disclosure of the study information 2016/08/15
Last modified on 2017/08/09

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Basic information
Public title study of milk test as a preventive method for chylous ascites following pancreatectomy
Acronym study of milk test following pancreatectomy
Scientific Title study of milk test as a preventive method for chylous ascites following pancreatectomy
Scientific Title:Acronym study of milk test following pancreatectomy
Region
Japan

Condition
Condition patients who will undergo pancreatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the efficacy of milk test.
Basic objectives2 Others
Basic objectives -Others detection of the site of lymph flow leakage, and effecacy of the usage of sealing device
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes observation of white milky discharge
comparison of milk test positivity
Key secondary outcomes comparison of the difference of sealing devices

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 milk injection group
Interventions/Control_2 Sham group
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient who obtained the consent to this study in pancreatectomy.
Key exclusion criteria As follows
Patient who refused to participate a study ,and who has allergy for milk, and who cannnot be inserted nasal tube, and who undergo laparoscopic surgery.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Aoki
Organization Iwakuni Clinical Center
Division name Surgery
Zip code
Address 1-1-1 Atago Iwakuni Yamaguchi
TEL 0827-34-1000
Email aoki@iwakuni-nh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Aoki
Organization Iwakuni Clinical Center
Division name Surgery
Zip code
Address 1-1-1 Atago Iwakuni Yamaguchi
TEL 0827-34-1000
Homepage URL http://www.iwakuni-nh.go.jp/
Email aoki@iwakuni-nh.go.jp

Sponsor
Institute Iwakuni Clinical Center
Institute
Department

Funding Source
Organization Iwakuni Clinical Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 福山市民病院(広島県)
広島市民病院(広島県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 15 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 No longer recruiting
Date of protocol fixation
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 29 Day
Last follow-up date
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter observational study

Management information
Registered date
2016 Year 08 Month 08 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027078

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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