UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057486 |
|---|---|
| Receipt number | R000065682 |
| Scientific Title | A Multi-institutional Study on the Usefulness of Intraoperative Echo-Navigation System Using Fusion Technology in Hepatobiliary and Pancreatic Surgery |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 20:17:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Multi-institutional Study on the Usefulness of Intraoperative Echo-Navigation System in Hepatobiliary and Pancreatic Surgery
Acronym
A Multi-institutional Study on the Usefulness of Intraoperative Echo-Navigation System in Hepatobiliary and Pancreatic Surgery
Scientific Title
A Multi-institutional Study on the Usefulness of Intraoperative Echo-Navigation System Using Fusion Technology in Hepatobiliary and Pancreatic Surgery
Scientific Title:Acronym
A Multi-institutional Study on the Usefulness of Intraoperative Echo-Navigation System Using Fusion Technology in Hepatobiliary and Pancreatic Surgery
Region
| Japan |
Condition
Condition
Malignant or borderline malignant tumors in the hepatobiliary and pancreatic regions
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the accuracy and usefulness of intraoperative echo-navigation system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy between preoperative and ultrasound images after Registration
Key secondary outcomes
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 who are scheduled for laparotomy and need intraoperative ultrasound (IOUS) to identify vascular or neoplastic lesions that can be noted on preoperative imaging.
2) Patients who have undergone either preoperative CT or MRI imaging studies.
3) Patients who are at least 18 years old and have given informed consent.
Key exclusion criteria
1) Patients with a cardiac pacemaker
2) Patients with a history of open liver resection (not including laparoscopic surgery)
3) Patients who are deemed unsuitable for use by the investigator or attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Miyata |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
akmiyat@ncc.go.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Miyata |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
akmiyat@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Canon Medical Systems
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
chuo-rinrishinsa@dl.ncc.go.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
| 2025 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obtain clinical information on the following items.
Basic information (gender, age, performance status, presence/absence of history, details of pre-existing conditions, presence/absence of complications, details of complications, presence/absence of family history, details of family history, life history, blood test data (white blood cell, CRP, Hb, Ca, tumor markers), etc.).
Tumor information (date of diagnosis, stage, tumor site, metastatic site, tumor diameter, changes in tumor diameter during treatment, information on metastasis/recurrence, imaging data such as CT, MRI, ultrasound, PETCT, etc.).
Treatment and prognosis information (type and details of treatment, presence or absence of adverse events and details, recurrence or absence of recurrence, change in outcome, date of last confirmed survival, etc.).
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065682
