UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027898 |
|---|---|
| Receipt number | R000031966 |
| Scientific Title | The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction using indocyanine green angiography |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2023/06/28 09:36:22 |
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Basic information
Public title
The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction using indocyanine green angiography
Acronym
The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction
Scientific Title
The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction using indocyanine green angiography
Scientific Title:Acronym
The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction
Region
| Japan |
Condition
Condition
Pancreatic cancer with arterial invasion
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction using indocyanine green angiography
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery, frequency of hepatic infarction or mesenteric ischemia
Key secondary outcomes
frequency of the postoperative complication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We observe the indocianine green fluoroscence flow of reconstructed aetery and hepatic/intestine after i.v. of indocianine green 2.5mg/1ml
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients undergone pancreatectomy with artery reconstruction
2) Patients with the consent of the document has been obtained from the person himself/herself to become the subject of this examination
Key exclusion criteria
1) Patient with iodinated contrast agent allergy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamaue |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department od Surgery
Zip code
641-8510
Address
Kimiidera 811-1, Wakayama, Japan
TEL
0734410613
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Okada |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department od Surgery
Zip code
641-8510
Address
Kimiidera 811-1, Wakayama, Japan
TEL
0734410613
Homepage URL
okada@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department od Surgery, Wakayama Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department od Surgery, Wakayama Medical University, School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
Kimiidera, 811-1, Wakayama City, Wakayama
Tel
0734410714
okada@wakayama-med.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
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
doi:10.21873/anticanres.15476
Publication of results
Published
Result
URL related to results and publications
doi:10.21873/anticanres.15476
Number of participants that the trial has enrolled
9
Results
Nine prospectively-registered consecutive patients with PNBC were enrolled, all underwent pancreatoduodenectomy with common hepatic artery en-bloc resection (PD-CHAR). We investigated the safety of PD-CHAR by blood flow evaluation with intraoperative indocyanine green fluorescence imaging in reconstructed vessels/organs. Results: Among patients who underwent PD-CHAR, there was no severe morbidity. Artery/portal vein combined resection and reconstruction was performed in all patients.
Results date posted
| 2023 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 01 | Month | 21 | Day |
Baseline Characteristics
Patient with pancreatic cancer involving major artery
Participant flow
Prospective observational study
Adverse events
None
Outcome measures
Safety & feasibility
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031966
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