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Satety and efficacy of dual-wield parenchymal transection for liver resection using Cavitron Ultrasonic Surgical Aspirator and water-jet scalpel

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

20

Between June 2022 and May 2023, 20 patients were enrolled in the study and underwent open hepatectomy using dual-wield parenchymal transection method. One patient was found to be ineligible after surgery and the safety analysis set included 20 patients, and Full analysis set (FAS) and Per protocol set (PPS) were 19 patients. In the FAS and PPS, the median age of the patients was 71 years (range 35-82), 13 (68.4%) were male and 6 (31.6%) were female, and the median body mass index was 22.8 kg/m2 (range 18.9-32.2). Thirteen patients had primary liver cancer (68.4%), five had secondary hepatic malignancies (26.3%), and one had hemangioma (5.3%). The median number of tumors was 1 (range, 1-4), and the median maximum tumor size was 40 mm (range, 9-160).

The registration period needed to be extended by six months. Finally, 15 cases were enrolled from Hiroshima University Hospital and 5 cases from the National Hospital Organization Kure Medical Center. Hepatectomy using dual-wield parenchymal transection was performed in all 20 cases, but one case was ineligible because the indication of surgery was not a liver tumor but a hepatic resection for postoperative bile leak. Finally, the safety analysis population consisted of 20 cases, and FAS and PPS consisted of 19 cases.

Safety was evaluated in 20 patients in the safety analysis population. There were no device failure and adverse events associated with devices.

The primary and secondary endpoints were analyzed in 19 patients in the FAS and PPS; the FAS and PPS population were the same. Primary endpoint Intraoperative massive bleeding greater than 1000 mL was observed in 5 patients (26.3%). Secondary endpoints Operative findings: Median operative time was 346 minutes (range, 238-543), median blood loss was 545 mL (range, 180-4413), median transection time was 89 minutes (range, 13-308), the median transection speed was 1.277 cm2/min (range, 0.49-5.14) for patients who underwent sectionectomy, and 0.955 cm2/min (range, 0.54-2.73) for those who underwent segmentectomy and hemihepatectomy. The median Pringle maneuver time and count was 69 minutes (range, 30-226) and 5 (2-13), respectively. The median hospital stay was 11 days (9-116). Postoperative complications: Postoperative complications occurred in 11 patients (57.9%). According to the Clavien-Dindo classification, 13 postoperative complications less than Grade 2 was occurred, and 4 patients (21.1%) had complications greater than Grade 3. One case of postoperative pleural effusion was treated by thoracic drainage and recovered. Two patients developed postoperative bile leakage, both of which were treated with percutaneous drainage and antibiotics administration. One of the patients required intensive care unit treatment temporarily, but later recovered. One patient required reoperation for postoperative bleeding with hemostasis. Intraoperative findings showed that the bleeding was not on the parenchymal transection surface but at the site of dissection for adhesions, and was not related to the DWT. The patient had an uneventful postoperative course and recovered well. Post-hepatectomy liver failure (PHLF) and bile leakage according to the International Study Group of Liver Surgery classification: PHLF was observed in 5 patients (26.3%), 3 with Grade A and 2 with Grade B. The two Grade B patients were treated with diuretics and recovered. Two patients had Grade B bile leakage. Two patients had Grade B postoperative bile leaks, both of which recovered with drainage and antibiotics. Mortality: There were no mortalities in this study.

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.

Jan. 15, 2024

Nov. 18, 2023

https://www.cureus.com/articles/198522-a-multicenter-open-label-single-arm-phase-i-trial-of-dual-wield-parenchymal-transection-a-new-technique-of-liver-resection-using-the-cavitron-ultrasonic-surgical

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs062220031

Ohdan Hideki

Hiroshima University Hospital

1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima

hohdan@hiroshima-u.ac.jp

Kobayashi Tsuyoshi

Hiroshima University Hospital

1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima

+81-82-257-5222

tsukoba@hiroshima-u.ac.jp

Complete

June. 09, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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 .

Both

Liver tumor

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.

Liver tumor, liver resection

Water-jet scalpel

D008113

D046650

Percentage of cases with massive intraoperative bleeding (1000 ml or more)

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)

+81-82-257-1551

April. 13, 2022

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