UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058919 |
|---|---|
| Receipt number | R000067365 |
| Scientific Title | A Prospective Observational Study on Robot-Assisted Pancreatectomy |
| Date of disclosure of the study information | 2025/08/28 |
| Last modified on | 2025/08/28 17:49:49 |
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Basic information
Public title
A Prospective Observational Study on Robot-Assisted Pancreatectomy
Acronym
RAP Study (Robot-Assisted Pancreatectomy Study)
Scientific Title
A Prospective Observational Study on Robot-Assisted Pancreatectomy
Scientific Title:Acronym
RAP Study (Robot-Assisted Pancreatectomy Study)
Region
| Japan |
Condition
Condition
Pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical validity of robot-assisted pancreatectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Surgical safety (intraoperative blood loss, operative time, presence or absence of conversion to open surgery, intraoperative adverse events)
Key secondary outcomes
Postoperative complications, reoperation, and length of postoperative hospital 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled to undergo robot-assisted pancreatoduodenectomy or robot-assisted distal pancreatectomy for pancreatic disease.
2) Patients aged 20 years or older on the date of registration.
3) Patients considered operable for robot-assisted pancreatoduodenectomy or distal pancreatectomy.
Key exclusion criteria
1) Patients with psychiatric disorders or symptoms that interfere with daily life, making it difficult to participate in the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Nagai |
Organization
Graduate School of Medicine and Faculty of Medicine Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
6068507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
0757514323
ykspirit@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yamane |
Organization
Graduate School of Medicine and Faculty of Medicine Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
6068507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
0757514323
Homepage URL
ykspirit@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Kei Yamane
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
0753667618
ethcom@kuhp.kyoto-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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After providing an explanation to patients scheduled for robot-assisted pancreatectomy and obtaining their informed consent, patient registration will be conducted. Observations will continue until withdrawal of consent, patient death, or up to 90 days postoperatively, whichever occurs first.
Management information
Registered date
| 2025 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067365
