Department of Anaesthesiology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.
Department of Anaesthesiology, Peking University International Hospital, Beijing, China.
BMJ Open. 2024 Mar 29;14(3):e080562. doi: 10.1136/bmjopen-2023-080562.
Liver disease causes 2 million deaths annually, accounting for 4% of all deaths worldwide. Liver surgery is one of the effective therapeutic options. Bleeding is a major complication during liver surgery. Perioperative bleeding and allogeneic blood transfusion may deteriorate the prognosis. Terlipressin (TP), a synthetic analogue of the antidiuretic hormone, may reduceblood loss during abdominal surgery. Several clinical centres have attempted to use TP during liver surgery, but the evidence for its effectiveness in reducing blood loss and the need for allogeneic blood transfusion, as well as its safety during the perioperative period, remains unclear. The aim of this systematic review and meta-analysis is to evaluate the efficacy and safety of TP in reducing blood loss and allogeneic blood transfusion needs during liver surgery.
We will search PubMed, EMBASE, the Cochrane Library and Web of Science for studies on perioperative use of TP during liver surgery from inception to July 2023. We will limit the language to English, and two reviewers will independently screen and select articles. The primary study outcomes are estimated blood loss and the need for allogeneic blood transfusion. Secondary outcomes include operating time, intensive care unit stay, length of stay, intraoperative urine output, acute kidney injury rate, postoperative complications, hepatic and renal function during follow-up, and TP-related adverse effects. We will include studies that met the following criteria: (1) randomised controlled trials (RCTs), cohort studies or case-control studies; (2) the publication time was till July 2023; (3) adult patients (≥18 years old) undergoing elective liver surgery; (4) comparison of TP with other treatments and (5) the study includes at least one outcome. We will exclude animal studies, case reports, case series, non-original articles, reviews, paediatric articles, non-controlled trials, unpublished articles, non-English articles and other studies that are duplicates. We will use Review Manager V.5.3 software for meta-analysis and perform stratification analysis for the study quality of RCTs based on the Jadad score. For cohort or case-control studies, the study quality will be analysed based on Newcastle-Ottawa Scale scores. Grading of Recommendations, Assessment, Development and Evaluation will be used to assess confidence in the cumulative evidence. For primary outcomes, we will conduct subgroup analyses based on meta-regression. We will also perform leave-one-out sensitivity analyses to evaluate the effect of each individual study on the combined results by removing the individual studies one by one for outcomes with significant heterogeneity. The protocol follows the Cochrane Handbook for Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines.
This study is a secondary analysis of existing data; therefore, it does not require ethical approval. We will disseminate the results through peer-reviewed publications.
CRD42023450333.
肝脏疾病每年导致 200 万人死亡，占全球所有死亡人数的 4%。肝脏手术是有效的治疗选择之一。出血是肝脏手术的主要并发症。围手术期出血和异体输血可能会使预后恶化。特利加压素（TP）是一种抗利尿激素的合成类似物，可能会减少腹部手术中的失血。一些临床中心试图在肝脏手术中使用 TP，但它在减少失血和异体输血需求方面的有效性、围手术期的安全性以及其在减少失血和异体输血需求方面的安全性的证据仍然不清楚。本系统评价和荟萃分析的目的是评估 TP 在减少肝脏手术围手术期失血和异体输血需求方面的疗效和安全性。
我们将从成立到 2023 年 7 月，在 PubMed、EMBASE、Cochrane 图书馆和 Web of Science 上搜索关于围手术期使用 TP 进行肝脏手术的研究。我们将语言限制为英语，两名评审员将独立筛选和选择文章。主要研究结果是估计出血量和异体输血需求。次要结果包括手术时间、重症监护病房停留时间、住院时间、术中尿量、急性肾损伤发生率、术后并发症、随访期间的肝肾功能以及与 TP 相关的不良反应。我们将纳入符合以下标准的研究：（1）随机对照试验（RCT）、队列研究或病例对照研究；（2）发表时间截至 2023 年 7 月；（3）接受择期肝脏手术的成年患者（≥18 岁）；（4）与其他治疗方法进行比较；（5）研究至少包含一个结局。我们将排除动物研究、病例报告、病例系列、非原创文章、综述、儿科文章、非对照试验、未发表的文章、非英语文章和其他重复的文章。我们将使用 Review Manager V.5.3 软件进行荟萃分析，并根据 Jadad 评分对 RCT 的研究质量进行分层分析。对于队列或病例对照研究，将根据纽卡斯尔-渥太华量表评分分析研究质量。推荐、评估、制定和评估分级将用于评估累积证据的置信度。对于主要结局，我们将根据荟萃回归进行亚组分析。对于存在显著异质性的结局，我们还将通过逐一删除个别研究，进行失一个体敏感性分析，以评估每个个体研究对合并结果的影响，从而进行敏感性分析。该方案遵循 Cochrane 系统评价和荟萃分析首选报告项目手册的建议。
本研究是对现有数据的二次分析，因此不需要伦理批准。我们将通过同行评审出版物传播研究结果。
PROSPERO 注册号：CRD42023450333。
