A study of the efficacy of preoperative marking for liver tumors

JRCT ID: jRCTs062220088

Registered date:25/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Liver tumor
• Date of first enrollment: 15/09/2023
• Target sample size: 25
• Study type: Interventional

Intervention(s)

(1) Percutaneous Marking
For patients who undergo preoperative inpatient CT, ultrasound-guided percutaneous liver biopsy, or tumor biopsy, percutaneous placement of markers is performed at that time. As for the cost, the procedure is basically covered by insurance, and since the coils to be implanted at the same time are those listed below, no patient cost is incurred. The procedure is performed under the supervision of an IVR specialist or a specialist among the physicians of the Department of Diagnostic Radiology at Hiroshima University.
Percutaneous marking is performed under local anesthesia with CT and ultrasound guidance. Following the primary biopsy, another puncture is performed at the same location for marking purposes. A Chiba needle is used to puncture the tumor, the tip of which is placed near the tumor (within the range of simultaneous resection), and one or two microcoils are implanted through the needle. When puncturing for marking purposes, care should be taken not to puncture the tumor directly in order to avoid the risk of seeding due to direct puncture of the tumor. The puncture needle should be removed after implantation after confirming that there is no internal bleeding. The location of the marker should be confirmed by CT before and after placement, but be careful to minimize the extent and frequency of imaging and to increase radiation exposure.
The choice of the device used for marking is left to the surgeon's choice of the most appropriate device for each case. However, if the use of another company's device is deemed desirable at the time of marking, the use of that company's device is also acceptable.

(2) Transcatheter marking
For patients who are hospitalized for preoperative angiography, a marker is placed transcatheterly in the vicinity of the liver tumor. The cost of this procedure is basically covered by insurance, and since the coils to be implanted at the same time are those listed below, there is no cost to the patient. This procedure is performed by a physician in the Department of Diagnostic Radiology at Hiroshima University who primarily performs imaging-based therapy.
Transcatheter marking is performed following the main purpose of angiography. No new angiocentesis is performed for marking purposes. Under angiography, the microcatheter is advanced to the vicinity of the tumor (within the range of simultaneous resection), and the microcoil is implanted after confirming its position with CT. The position of the marker is confirmed by fluoroscopy and CT before and after the placement of the marker, but both the extent and number of imaging and the amount of contrast media used should be kept to the minimum necessary.
The choice of the device used for marking is left to the surgeon's selection of the most appropriate device for each case. However, if the use of another company's device is deemed desirable at the time of marking, the use of the device listed below is acceptable.

Product name: C-Stopper (Sales company: Piolax Medical Devices Co.)
Product name: Cook Embolization Coil (Tornado) (Sales company: Cook Medical Japan, LLC)
Product name: Cook Embolization Coil (Hilal) (Sales company: Cook Medical Japan, LLC)
Product name Target Detachable Coil (Sales company Stryker Japan K.K.)

Outcome(s)

• Primary Outcome: 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

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.
Complications during marking: bleeding, liver injury, biliary fistula, intestinal injury, pneumothorax, residuals in the body due to marker deviation, etc.
Surgical outcome: operation time, blood loss, liver resection weight
Postoperative liver dysfunction: analysis of postoperative AST, ALT, T.Bil, PT activity, Alb levels
Postoperative complications: postoperative liver failure, biliary fistula, intra-abdominal abscess, postoperative bleeding, operative mortality, postoperative hospital stay
Survey of surgeons' opinions on the contribution of marking to surgery

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Ohdan Hideki
• Source(s) of Monetary Support: Tsuchiya Memorial Medical Foundation