UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety study of preoperative marking for undetectable hepatic tumor
Acronym	Preoperative marking for undetectable hepatic tumor
Scientific Title	Efficacy and safety study of preoperative marking for undetectable hepatic tumor
Scientific Title:Acronym	Preoperative marking for undetectable hepatic tumor
Region	Japan

Condition
Condition	hepatic tumor requiring surgical resection
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	For liver tumors that can be confirmed on images with a diameter of 20 mm or less, preoperative marking is performed, exploring the safety of marking and completion of resection by surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	After marking, CT, ultrasound marker and tumor visibility (visible / impossible) Visibility (markable / impossible) of markers and tumor at hepatectomy Percentage of completion of markers and tumor resection Measurement of final marker and tumor distance
Key secondary outcomes	Complications during marking Surgery results Postoperative liver dysfunction Postoperative complication

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Percutaneous marking for liver tumor Transcatheteratic marking for liver tumors
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	1. Patient scheduled for diagnosis for liver tumor. 2. Patient who is scheduled for hepatectomy for hepatic tumor. 3. Patient whose Performance Status (PS) of the Eastern Cooperative Oncology Group (ECOG) is 0 - 1. 4. Male or female aged 20 years or older at the time of acquiring consent (no outpatient or hospitalization is acceptable). 5. Patients who have obvious tumorous lesions in the liver due to various imaging tests such as CT and MRI. Although the number of tumors is not specified, only one tumor to be marked is 20 mm or less in diameter. 6. Patient who satisfies the following criteria in the blood test at the time of registration, and retains the functions of major organs (bone marrow, liver, kidney, lung, etc.). A) Leukocyte count: 2,000 / mm 3 or more B) Hemoglobin content: not less than 8.0 g / dl C) Number of platelets: 50,000 / mm 3 or more D) Total bilirubin: 3.0 mg / dl or less E) eGFR: 60 ml / min / 1.73 m 3 or more (In case of falling below, decide on pretreatment and treatment in accordance with the provision of "Angiography examination IVR for patients with impaired renal function" in the hospital. 7. Patient who has sufficient judgment ability to understand the research contents and obtained written consent for participation of this study. 8. Patient who can withdraw anticoagulant on the day of marking.
Key exclusion criteria	1. Patients with severe (NYHA class III or more) ischemic heart disease. 2. Patient who complicated of severe liver cirrhosis (hepatopathy degree C). 3. Patients with dyspnea requiring oxygen administration due to interstitial pneumonia, pulmonary fibrosis and others. 4. Patients who are undergoing dialysis with chronic renal failure. 5. Patients currently suffering from duplicated cancer of active activity. 6. Patients who are judged to be difficult to participate in research due to psychosis or psychiatric symptoms. 7. Other patients who are deemed inappropriate for the research researcher or research sharing doctor to conduct this research.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Ohdan
Organization	Hiroshima University Hospital
Division name	Department of gastroenterological surgery
Zip code	734-8551
Address	1-2-3, Kasumi, Hiroshima city, Japan
TEL	082-257-5222
Email	hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Shintaro Middle name Last name Kuroda
Organization	Hiroshima University Hospital
Division name	Department of gastroenterological surgery
Zip code	734-8551
Address	1-2-3, Kasumi, Hiroshima city, Japan
TEL	082-257-5222
Homepage URL
Email	shintarokuroda@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital Department of gastroenterological surgery
Institute
Department

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	Hiroshima University Hospital
Address	1-2-3, Kasumi, Hiroshima city, Japan
Tel	082-257-1725
Email	protocol@cimr.hiroshima-u.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	広島大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 09 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	19
Results	Preoperative marking for liver tumors could be performed without major adverse events.
Results date posted	2022 Year 02 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Cases with liver tumors that are expected to be difficult to identify during surgery and require hepatectomy
Participant flow	Hepatectomy after preoperative marking
Adverse events	none
Outcome measures	Safety
Plan to share IPD	none
IPD sharing Plan description	none

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 09 Day
Date of IRB	2017 Year 08 Month 07 Day
Anticipated trial start date	2017 Year 08 Month 19 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 08 Month 09 Day
Last modified on	2022 Year 02 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032743