Dual-wield parenchymal transection for liver resection using Cavitron Ultrasonic Surgical Aspirator and water-jet scalpel

JRCT ID: jRCTs062220031

Registered date:09/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Liver tumor
• Date of first enrollment: 24/06/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): In current liver surgery, transection of liver parenchymal is performed by two surgeons using CUSA and bipolar. In this study, in addition to CUSA and bipolar, water-jet scalpel is used simultaneously by another surgeonf for liver parenchymal transection.

Outcome(s)

• Primary Outcome: Percentage of cases with massive intraoperative bleeding (1000 ml or more)

Secondary Outcome

1. Surgical factors (total operation time, time of liver parencymal transection, velocity of liver parencymal transection, time of liver inflow occlusion, number of liver inflow occulusion, intraoperative bleeding)
2. Short-term postoperative outcome (incidence of all postoperative complications based on Clavien-Dindo classification, incidence of post-hepatectomy liver failure and bile fistula based on the ISGLS definition, surgical mortality, post-operative stay)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who undergo anatomical liver resection for primary or metastastic liver tumor.
2. Patients with Performance Status (PS) 0-1 of Eastern Cooperative Oncology Group (ECOG).
3. Patients over 20 years old.
4. Patients without extrahepatic lesions. However, patients with extrahepatic lesions could be included if excision of intrahepatic lesion prolongs theirprognosis.
5. Patients who meet following criteria of blood examination.
A) White blood cell cout: 2000/mm3 or more.
B) Hemoglobin: 8.0 g/dL or more.
C) Platelet count: 50,000/mm3 or more.
D) Total bilirubin: 3.0 mg/dL or less.
E) Prothrombin activity: 50 % or more.
F) Creatinine: 2.0 mg/dL or less
6. Patients who understand the contents of this study.

Exclude criteria

1. Patients who undergo liver resection with biliary duct reconstructon.
2. Patients who undergo liver resection witu revascularization.
3. Patients who undergo simultaneous surgery for other organ, exepting cholecystectomy.
4. Patients with severe ischemic heart disease (NYHA clasicifation grade III or IV).
5. Patients with severe cirrhosis (Liver damage grade C).
6. Patients required continuous oxygen administration due to severe lung disease.
7. Patiets with severe or uncontrollable coagulapathy.
8. Patients who receive treatment for active cancer of other organs.
9. Patietns who are lactating or pregnant.
10. Patients who are dfficult to enroll in this study due to their mental illness.
11. Patients who undergo dialysis.
12. Patients implanted with medical electronic devices such as pacemakers and implantable cardioverter-defibrillators.
13. Patients who are deemed inappropriate for this study by the investigator .

Related Information

• Primary Sponsor: Ohdan Hideki
• Source(s) of Monetary Support: AMCO INC.