UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051375 |
|---|---|
| Receipt number | R000058609 |
| Scientific Title | Feasibility of Planned modified Regional Pancreatoduodenectomy for Pancreatic Head Ductal Adenocarcinoma |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2023/06/18 23:10:24 |
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Basic information
Public title
Feasibility of Planned modified Regional Pancreatoduodenectomy for Pancreatic Head Ductal Adenocarcinoma
Acronym
Feasibility of Pl-mRPD for PhDAC
Scientific Title
Feasibility of Planned modified Regional Pancreatoduodenectomy for Pancreatic Head Ductal Adenocarcinoma
Scientific Title:Acronym
Feasibility of Pl-mRPD for PhDAC
Region
| Japan |
Condition
Condition
Eligibility included histologically proven resectable (R) or borderline resectable (BR) pancreatic ductal adenocarcinoma with contact of SMV/PV.
Exclusion criteria was liver/lung metastasis, para-aortic lymph node metastasis positive or peritoneal metastasis.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary endpoint was feasibility rate of preoperative planned portal vein resection.
Basic objectives2
Others
Basic objectives -Others
The secondary endpoint was safety including operative outcomes (duration of surgery, blood loss and transfusion) and postoperative outcomes (hospital stay, in-hospital mortality and morbidity, pathological findings, patency rate of portal vein).
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was feasibility rate of preoperative planned portal vein resection.
Key secondary outcomes
The secondary endpoint was safety including operative outcomes (duration of surgery, blood loss and transfusion) and postoperative outcomes (in-hospital mortality and morbidity, pathological findings, patency rate of portal vein).
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
Eligibility included histologically proven resectable (R) or borderline resectable (BR) pancreatic ductal adenocarcinoma with contact of SMV/PV.
Key exclusion criteria
Exclusion criteria was lung and liver metastasis, para-aortic lymph node metastasis positive, lavage cytology positive or peritoneal metastasis.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Saiura |
Organization
Juntendo University School of Medicine
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
m_terasawa2000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Muga |
| Middle name | |
| Last name | Terasawa |
Organization
Juntendo University School of Medicine
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
m_terasawa2000@yahoo.co.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421
Tel
03-5802-1584
hongo-rinri@juntendo.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 | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 17 | Day |
Other
Other related information
A Non-interventional Prospective Observational Study in the patient with Pancreatic head cancer undergoing pancreatoduodenectomy with preoperatively planned portal vein resection
Management information
Registered date
| 2023 | Year | 06 | Month | 18 | Day |
Last modified on
| 2023 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058609
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| Registered date | File name |
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| Registered date | File name |
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