Bin Liang, Yufu Peng, Wugui Yang, Yubo Yang, Bo Li, Yonggang Wei, Fei Liu
{"title":"腹腔镜肝实质横断使用CUSA与谐波手术刀:一项前瞻性随机对照试验方案。","authors":"Bin Liang, Yufu Peng, Wugui Yang, Yubo Yang, Bo Li, Yonggang Wei, Fei Liu","doi":"10.1177/17562848251348974","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>The study aims to investigate the feasibility, safety, and efficiency of HS in LLR compared with CUSA.</p><p><strong>Design: </strong>This is a study protocol for a randomized controlled trial (RCT).</p><p><strong>Methods and analysis: </strong>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.</p><p><strong>Ethics: </strong>The trial has been reviewed and approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University, on January 19, 2024.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>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.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251348974"},"PeriodicalIF":3.4000,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12202911/pdf/","citationCount":"0","resultStr":"{\"title\":\"Laparoscopic liver parenchymal transection using CUSA versus harmonic scalpel: a protocol for a prospective randomized controlled trial.\",\"authors\":\"Bin Liang, Yufu Peng, Wugui Yang, Yubo Yang, Bo Li, Yonggang Wei, Fei Liu\",\"doi\":\"10.1177/17562848251348974\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>The study aims to investigate the feasibility, safety, and efficiency of HS in LLR compared with CUSA.</p><p><strong>Design: </strong>This is a study protocol for a randomized controlled trial (RCT).</p><p><strong>Methods and analysis: </strong>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.</p><p><strong>Ethics: </strong>The trial has been reviewed and approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University, on January 19, 2024.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>The study protocol was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn) on April 26, 2024, ChiCTR2400083493. 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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.
期刊介绍:
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.