UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047087 |
|---|---|
| Receipt number | R000053705 |
| Scientific Title | Studies of changes in cerebral blood flow and brain function using Near-infrared spectroscopy in laparoscopic hepatectomy. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/09/04 14:10:34 |
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Basic information
Public title
Studies of changes in cerebral blood flow and brain function using Near-infrared spectroscopy in laparoscopic hepatectomy.
Acronym
Studies of changes in cerebral blood flow and brain function using Near-infrared spectroscopy in laparoscopic hepatectomy.
Scientific Title
Studies of changes in cerebral blood flow and brain function using Near-infrared spectroscopy in laparoscopic hepatectomy.
Scientific Title:Acronym
Studies of changes in cerebral blood flow and brain function using Near-infrared spectroscopy in laparoscopic hepatectomy.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma and Inguinal hernia
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will use near-infrared spectroscopy to measure changes in cerebral blood flow due to pneumoperitoneum and surgical stress during laparoscopic hepatectomy, and examine its safety. In addition, changes in cerebral blood flow will be evaluated even in laparoscopic inguinal hernia surgery, which is relatively short-time and less invasive, and will be compared with laparoscopic hepatectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of cerebral blood flow and changes in oxygen metabolism by Near-infrared spectroscopy
Key secondary outcomes
Intelligence test, brain MRI, brain SPECT
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
(1) Patients with PS (ECOG classification) of 0 to 1
(2) Patients who retain the functions of major organs (bone marrow, liver, kidney, lungs, etc.)
White blood cell count: 12000/mm3 or less
Number of neutrophils: 1500/mm3 or more
Amount of hemoglobin: 9.0 g/dl or more
Platelet count: 100000/mm3 or more
Total bilirubin: 2.0 mg/dl or less (patients undergoing jaundice reduction for obstructive jaundice should be 3.0 mg/dl or less).
AST and ALT values: 150 U/L or less
Creatinine: 1.5mg/dl or less
Creatinine clearance is 50 mL/min or more (use the estimation formula of Cockcroft-Gault method. If there is an actual measurement value, give priority to the actual measurement value) Estimate formula = body weight (kg) * (140-age) / 72 * serum creatinine value (mg/dL). For women, multiply the value obtained by 0.85
(3) Patients who can take orally
(4) Patients who have given written consent to be the subject of this study
(5) Adults aged 18 years or older who have sufficient judgment to obtain consent for this study
(6) Patients with or without suspicion of infectious disease
Key exclusion criteria
(1)Patients who are contraindicated for MRI and SPECT
(2) Patients who are difficult to tolerate surgery
(3) Patients with active infectious diseases (fever 38.0 celsius or higher)
(4) Patients who may be pregnant or pregnancy
(5) Underage patients (under 18 years old)
(6) Patients who do not have sufficient judgment to obtain consent for the study
(7) Patients with bilateral inguinal hernias, donor patients
(8) Patients who are judged to be inappropriate for conducting this study safely by physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sasaki |
Organization
Iwate Medical University
Division name
department of surgery
Zip code
028-3695
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture
TEL
019-613-7111
sakira@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Iwasa |
Organization
Iwate Medical University
Division name
department of surgery
Zip code
028-3695
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture
TEL
019-613-7111
Homepage URL
itomo@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University department of surgery
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University department of surgery
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
Iwate Medical University Ethics Committee
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture
Tel
019-613-7111
rinri@iwate-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
| 2022 | Year | 04 | Month | 01 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement and analysis of cerebral blood flow and oxygen metabolism changes by NIRS
Blood gas analysis
Judgment of presence and degree of higher brain dysfunction
Measurement of cerebral white matter nerve fiber density by brain MRI
Cerebral cortex nerve cell density by brain 123I-iomazenil SPECT
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2022 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053705
