A study of the efficacy of preoperative marking for liver tumors
- Conditions
- iver tumorPrimary liver cancer, metastatic liver cancer
- Registration Number
- JPRN-jRCTs062220088
- Lead Sponsor
- Ohdan Hideki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
1.Patients who are already scheduled for percutaneous biopsy or contrast-enhanced catheterization for diagnostic purposes of liver tumor or liver tissue.
2.Patients scheduled for hepatic resection for liver tumor.
3.Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1.
4.Male or female patients (regardless of outpatient or inpatient status) who are at least 18 years of age at the time of consent.
5.Patients with clear tumor lesions in the liver on CT, MRI, or other imaging studies. The number of tumors is not specified.
6.Patients with no intervening organs in the puncture pathway and who are considered to be able to be punctured safely under CT or ultrasound guidance.
7.Patients who meet the following criteria in blood tests at the time of enrollment and whose major organs (bone marrow, liver, kidney, lungs, etc.) are still functional.
A) White blood cell count: 2,000/mm3 or higher
B) Hemoglobin level: 8.0 g/dL or higher
C) Platelet count: 50,000/mm3 or higher
D) Total bilirubin: 3.0 mg/dL or less
8.Patients who have sufficient judgment to understand the content of the study and have given written consent to participate in this study.
9.Patients who are able to take a break from anticoagulants on the day of marking.
1.Patients with severe ischemic heart disease (NYHA classification III or higher).
2.Patients with severe hepatic cirrhosis (hepatic impairment level C).
3.Patients with dyspnea requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis.
4.Patients on dialysis for chronic renal failure.
5.Patients with active multiple cancers who are currently undergoing treatment.
6.Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study.
7.Patients who are deemed inappropriate to participate in the study by the principal investigator or subinvestigator.
8.Patients with hypersensitivity to platinum alloys.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resection success rate of liver tumors: Successful resection is defined as a resection margin of at least 5 mm and less than 15 mm.
- Secondary Outcome Measures
Name Time Method After marking, measurement of marker and tumor visibility (visible/unvisible) on CT and ultrasound, marker and tumor visibility (visible/unvisible) during hepatic resection, and final distance between marker and tumor.<br>Complications during marking: bleeding, liver injury, biliary fistula, intestinal injury, pneumothorax, residuals in the body due to marker deviation, etc.<br>Surgical outcome: operation time, blood loss, liver resection weight<br>Postoperative liver dysfunction: analysis of postoperative AST, ALT, T.Bil, PT activity, Alb levels<br>Postoperative complications: postoperative liver failure, biliary fistula, intra-abdominal abscess, postoperative bleeding, operative mortality, postoperative hospital stay<br>Survey of surgeons' opinions on the contribution of marking to surgery