UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050542 |
|---|---|
| Receipt number | R000057543 |
| Scientific Title | The evaluation of postoperative clinical course after discharge of minimally invasive distal pancreatectomy |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2024/03/13 11:40:54 |
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Basic information
Public title
The evaluation of postoperative clinical course after discharge of minimally invasive distal pancreatectomy
Acronym
The evaluation of postoperative clinical course of minimally invasive distal pancreatectomy
Scientific Title
The evaluation of postoperative clinical course after discharge of minimally invasive distal pancreatectomy
Scientific Title:Acronym
The evaluation of postoperative clinical course of minimally invasive distal pancreatectomy
Region
| Japan |
Condition
Condition
pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety of early discharge after minimally invasive distal pancreatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the achievement rate of early discharge
Key secondary outcomes
1,Postoperative complication rate within 30 days
2,Readmission rate within 30 days
3,operative time
4,the amount of intraoperative blood loss
5,intraoperative complications
6,Presence of pancreatic fistula
7.Postoperative hospitalization stay
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are more than and equal to 18 years old and undergo minimally invasive distal pancreatectomy
Key exclusion criteria
Patients < 18 years old
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hasegawa |
Organization
The University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
hasegawa-2su@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | Sawa |
Organization
The University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
ysawa-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
other
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
The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-3600
hy-ohrs@m.u-tokyo.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Postoperative care will be provided within the scope of usual practice for patients who have undergone minimally invasive distal pancreatectomy, and observational studies will be conducted.
Management information
Registered date
| 2023 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057543
