Laparoscopic liver parenchymal transection using CUSA versus harmonic scalpel: a protocol for a prospective randomized controlled trial.

BACKGROUND

The harmonic scalpel (HS) and cavitron ultrasonic surgical aspirator (CUSA) are two common techniques for liver parenchymal transection (LPT). The second International Consensus Conference on laparoscopic liver resection (LLR) recommended the utilization of the HS for superficial layer LPT and the CUSA for deep layer LPT. Some centers currently employ the HS for deep-layer LPT. However, the potential effect of HS during deep layer transection in LLR remains unclear.

OBJECTIVES

The study aims to investigate the feasibility, safety, and efficiency of HS in LLR compared with CUSA.

DESIGN

This is a study protocol for a randomized controlled trial (RCT).

METHODS AND ANALYSIS

This RCT will be carried out at West China Hospital of Sichuan University from January 2024 to December 2025. Consecutive patients who underwent LLRs during this period will be recruited based on the specified inclusion and exclusion criteria. The participants will be randomly allocated to the HS group or the CUSA group. The primary outcome is intraoperative blood loss. Secondary outcomes include parenchymal transection velocity, operative time, conversion rate, postoperative hospital stays, hospital cost, morbidity, and mortality. Subgroup analysis will be performed according to liver cirrhosis. The corresponding statistical approach will be used for statistical analysis.

ETHICS

The trial has been reviewed and approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University, on January 19, 2024.

DISCUSSION

This study will clarify the feasibility, safety, and efficiency of HS for LPT in LLRs. The results will provide more reliable clinical evidence for the selection of LPT devices in LLRs.

TRIAL REGISTRATION

The study protocol was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn) on April 26, 2024, ChiCTR2400083493. The protocol version is V2.0.