UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042700 |
|---|---|
| Receipt number | R000048733 |
| Scientific Title | A Multicenter, single-blind, randomized, parallel-group trial examing the Effectiveness of Precompression during Distal Pancreatectomy. |
| Date of disclosure of the study information | 2020/12/09 |
| Last modified on | 2024/06/12 12:28:10 |
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Basic information
Public title
A Multicenter, single-blind, randomized, parallel-group trial examing the Effectiveness of Precompression during Distal Pancreatectomy.
Acronym
HiSCO-10 trial
Scientific Title
A Multicenter, single-blind, randomized, parallel-group trial examing the Effectiveness of Precompression during Distal Pancreatectomy.
Scientific Title:Acronym
HiSCO-10 trial
Region
| Japan |
Condition
Condition
Patients who underwent distal pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the lower incidence of pancreatic fistulas in distal pancreatectomy in the group with parenchymal precompression compared to the group without precompression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Grade B/C postoperative pancreatic fistula within one month after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Precompression of pancreatic parenchyma with intestinal clamp.
Interventions/Control_2
Without Precompression
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
1.Patients who underwent distal pancreatectomy
2.Performance Status(PS)is 0-1 of Eastern Cooperative Oncology Group(ECOG)
3.more than 20 years old
4.Patients without distant metastasis excepting for liver metastasis from neuroendocrine tumor
5.Patients whose function of main organs is maintained.
6.Patients who can understand the contents of this clinical trial
Key exclusion criteria
1.patients with severe ischemic heart disease(NYHA > III)
2.patients with grade C liver damage
3.patients required continuous oxygen administration due to severe lung disease
4.patients who received dialysis
5.patients with active cancer disease that may influence perioperative adverse events.
6.Patients who enable to enroll in this trial due to their mental illness.
7.Patients who reject to enroll in this trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Uemura |
Organization
Hiroshima University Hospital
Division name
Gastrointestinal Surgery
Zip code
7348551
Address
1-2-3,KASUMI, MINAMI-KU, Hiroshima, JAPAN
TEL
082-257-5215
umk@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Seo |
Organization
Hiroshima University Hospital
Division name
Gastrointestinal Surgery
Zip code
7348551
Address
1-2-3,KASUMI, MINAMI-KU, Hiroshima, JAPAN
TEL
082-257-5215
Homepage URL
seoshin5@yahoo.co.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Hiroshima University Hospital
Address
1-2-3,KASUMI, MINAMI-KU, Hiroshima, JAPAN
Tel
082-257-5215
protocol@cimr.hiroshima-u.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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 09 | 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
182
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
| 2020 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048733
