UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023542 |
|---|---|
| Receipt number | 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 | 2023/08/14 15:03:47 |
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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 | HIDEKI |
| Middle name | |
| Last name | AOKI |
Organization
Iwakuni Clinical Center
Division name
Surgery
Zip code
740-8510
Address
1-1-1 Atago Iwakuni Yamaguchi
TEL
0827-34-1000
aoki.hideki.hy@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | HIDEKI |
| Middle name | |
| Last name | AOKI |
Organization
Iwakuni Clinical Center
Division name
Surgery
Zip code
740-8510
Address
1-1-1 Atago Iwakuni Yamaguchi
TEL
0827-34-1000
Homepage URL
http://www.iwakuni-nh.go.jp/
aoki.hideki.hy@mail.hosp.go.jp
Sponsor or person
Institute
Iwakuni Clinical Center
Institute
Department
Personal name
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
Iwakuni Clinical Center
Address
1-1-1 Atago Iwakuni Yamaguchi JAPAN
Tel
0827341000
oda.yumie.zy@mail.hosp.go.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
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
253
Results
Drain triglyceride level was significantly higher in milk test positive cases and
chyle leak grade A cases, but it was not a predictor of postoperative chylous ascites.
Without the milk test, Grade B chyle leaks occurred twice as often,
but this was not statistically significant.
Incidence of chyle leak was significantly lower in milk test negative cases
than milk test positive cases.
Results date posted
| 2022 | Year | 08 | Month | 16 | Day |
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
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | 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
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027078
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/08/17 | milk test計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/08/17 | milk test計画書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/08/17 | milk test RCT.xlsx |
