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Efficacy and safety study of preoperative marking for undetectable hepatic tumor

Efficacy and safety study of preoperative marking for undetectable hepatic tumor - Preoperative marking for undetectable hepatic tumor

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028608
Enrollment
20
Registered
2017-08-09
Start date
2017-08-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatic tumor requiring surgical resection

Interventions

Percutaneous marking for liver tumor Transcatheteratic marking for liver tumors

Sponsors

Hiroshima University Hospital Department of gastroenterological surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Complications during marking Surgery results Postoperative liver dysfunction Postoperative complication

Countries

Japan

Contacts

Public ContactShintaro Kuroda

Hiroshima University Hospital Department of gastroenterological surgery

shintarokuroda@hiroshima-u.ac.jp082-257-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026