UMIN-CTR Clinical Trial

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
Email	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
Email	itomo@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical University department of surgery
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053705