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

Not Applicable

• Conditions: iver tumor; Liver tumor, liver resection; D008113

• Registration Number: JPRN-jRCTs062220031
• Lead Sponsor: Ohdan Hideki

Brief Summary

This study demonstrated the safety and feasibility of the DWT in open anatomical hepatectomy. This is the first report of a surgical technique in which CUSA and WJS were used simultaneously in parenchymal transection, and DWT was considered to be effective for the transection time and blood loss in some cases. To show the efficacy of DWT, prospective study to evaluate efficacy and safety of DWT in patients who will undergo hepatectomy focusing on the total blood loss and transection speed is needed.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-09
• Study Completion: 2023-05-12
• Results First Posted: 2023-11-18
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion 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.

Exclusion 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 .

Study & Design

• Study Type: Interventional
• Study Design: Not specified