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。

IF 3.4 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Therapeutic Advances in Gastroenterology Pub Date : 2025-06-23 eCollection Date: 2025-01-01 DOI:10.1177/17562848251348974
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. 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\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848251348974\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848251348974","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

背景:谐波刀(HS)和空腔超声手术吸引器(CUSA)是肝实质横断(LPT)的两种常用技术。第二届国际腹腔镜肝切除术共识会议(International Consensus Conference on腹腔镜liver resection, LLR)推荐浅层肝切除术采用HS,深层肝切除术采用CUSA。一些中心目前使用HS进行深层LPT。然而,在LLR的深层横断中,HS的潜在影响尚不清楚。目的:探讨HS与CUSA治疗LLR的可行性、安全性和有效性。设计:这是一个随机对照试验(RCT)的研究方案。方法与分析:本随机对照试验于2024年1月至2025年12月在四川大学华西医院进行。在此期间,将根据指定的纳入和排除标准招募连续的llr患者。参与者将被随机分配到HS组或CUSA组。主要结局是术中失血。次要结局包括实质横断速度、手术时间、转换率、术后住院时间、住院费用、发病率和死亡率。根据肝硬化情况进行亚组分析。统计分析将采用相应的统计方法。伦理:本试验已于2024年1月19日通过四川大学华西医院生物医学伦理审查委员会的审查并批准。讨论:本研究将阐明HS治疗LLRs LPT的可行性、安全性和有效性。本研究结果将为LLRs中LPT装置的选择提供更可靠的临床依据。试验注册:研究方案已于2024年4月26日在中国临床试验注册中心(http://www.chictr.org.cn)注册,注册号为ChiCTR2400083493。协议版本为V2.0。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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

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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Therapeutic Advances in Gastroenterology
Therapeutic Advances in Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
6.70
自引率
2.40%
发文量
103
审稿时长
15 weeks
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.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信