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儿童肝移植后门静脉阻塞的患病率、处理方法和治疗效果:回顾性国际多中心 PORTAL 登记研究方案。

Prevalence, management and efficacy of treatment in portal vein obstruction after paediatric liver transplantation: protocol of the retrospective international multicentre PORTAL registry.

机构信息

Department of Radiology, Medical Imaging Center, University Medical Centre Groningen, Groningen, The Netherlands.

King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.

出版信息

BMJ Open. 2023 Jul 27;13(7):e066343. doi: 10.1136/bmjopen-2022-066343.

Abstract

INTRODUCTION

Portal vein obstruction (PVO) consists of anastomotic stenosis and thrombosis, which occurs due to a progression of the former. The aim of this large-scale international study is to assess the prevalence, current management practices and efficacy of treatment in patients with PVO.

METHODS AND ANALYSIS

The Portal vein Obstruction Revascularisation Therapy After Liver transplantation registry will facilitate an international, retrospective, multicentre, observational study, with 25 centres around the world already actively involved. Paediatric patients (aged <18 years) with a diagnosed PVO between 1 January 2001 and 1 January 2021 after liver transplantation will be eligible for inclusion. The primary endpoints are the prevalence of PVO, primary and secondary patency after PVO intervention and current management practices. Secondary endpoints are patient and graft survival, severe complications of PVO and technical success of revascularisation techniques.

ETHICS AND DISSEMINATION

Medical Ethics Review Board of the University Medical Center Groningen has approved the study (METc 2021/072). The results of this study will be disseminated via peer-reviewed publications and scientific presentations at national and international conferences.

TRIAL REGISTRATION NUMBER

Netherlands Trial Register (NL9261).

摘要

简介

门静脉阻塞(PVO)包括吻合口狭窄和血栓形成,前者可进展为后者。本大规模国际研究旨在评估 PVO 患者的患病率、当前治疗方法和治疗效果。

方法和分析

门静脉阻塞再血管化治疗后肝移植登记处将促进一项国际性、回顾性、多中心、观察性研究,全球已有 25 个中心积极参与。2001 年 1 月 1 日至 2021 年 1 月 1 日在肝移植后诊断为 PVO 的小儿患者(年龄<18 岁)符合入选条件。主要终点是 PVO 的患病率、PVO 干预后的一级和二级通畅率以及当前的治疗方法。次要终点是患者和移植物存活率、PVO 的严重并发症和再血管化技术的技术成功率。

伦理和传播

格罗宁根大学医学中心医学伦理审查委员会已批准该研究(METc 2021/072)。该研究的结果将通过同行评议的出版物和在国家和国际会议上的科学演讲进行传播。

试验注册编号

荷兰试验注册(NL9261)。

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