WAUTEAR trial

JRCT ID: jRCTs052220071

Registered date:09/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Liver disease, or a healthy donor for living-donor liver transplantation.
• Date of first enrollment: 30/08/2022
• Target sample size: 250
• Study type: Interventional
• Intervention(s): After obtaining written consent, eligible participants are registered. Using EDC system, participants are randomly assigned to "waterjet device group" or "ultrasonic device group". Liver resection is performed with the assigned device. Blood loss amount is evaluated during liver parenchymal transection (primary endpoint) and other secondary endpoints during the perioperative period. As for safety, incidences of postoperative complications within 90 days after liver resection are evaluated.

Outcome(s)

• Primary Outcome: Blood loss during liver resection

Secondary Outcome

(1) Total blood loss amount during surgery.
(2) Blood loss amount per resected area during liver parenchymal resection.
(3) Total operating time.
(4) Operating time during liver parenchymal resection.
(5) Transection speed.
(6) Incidence of blood transfusion.
(7) Incidence of postoperative complications.
(8) Perioperative mortality.
(9) Postoperative days in hospital.

Key inclusion & exclusion criteria

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

Include criteria

(1) Age 20 years or older.
(2) ECOG Performance Status 0 to 2.
(3) Written consent provided.
(4) Scheduled to undergo (open/laparoscopic) liver resection due to liver disease, or to undergo liver resection as a donor for living-donor liver transplantation.
(5) Scheduled to undergo the following surgical procedures: right lobectomy, left lobectomy, right posterior sectionectomy, segment VII segmentectomy (for patients with liver disease) and right lobectomy, left lobectomy (for donors)

Exclude criteria

(1) Venous tumor thrombus (Vv2, 3).
(2) Biliary tumor thrombus (B3, 4).
(3) Needing biliary or vascular reconstruction.
(4) Dissection area overlaps with area of previous partial hepatectomy.
(5) Difficulty in taping hepatoduodenal ligament.
(6) Requiring resection of other organs except for gallbladder.
(7) BMI of 30 or more.
(8) Child-Pugh grade B or C.
(9) Platelet count <=10x104/micro-L.
(10) NYHA grade III or more.
(11) Implanted cardiac pacemaker or cardioverter defibrillator.
(12) Severe renal dysfunction (serum Cr >1.5 mg/dL).
(13) Severe respiratory dysfunction (forced expiratory volume in 1 second <1L or requiring rest because of shortness of breath during 100m or several minutes' walking).
(14) Other non-appropriate conditions, as determined by the principal investigator.

Related Information

• Primary Sponsor: Kawai Manabu
• Source(s) of Monetary Support: AMCO Inc.