未经证实:肝移植(LT)后的胆道并发症(BC)是导致严重发病率的原因。重建过程中没有技术程序与降低BC的风险有关。在初步研究中,在重建过程中放置导管内可移除支架(IRS),然后进行内窥镜移除显示出可行性和安全性。这项多中心随机对照试验旨在评估IRS对LT后BC的影响。
UNASSIGNED:这项多中心随机对照试验于2015年4月至2019年2月在7个中心进行。在LT期间,当确认至少1个残端直径≤7mm的导管到导管吻合时,进行随机化。在美国国税局组,将定制的T型管段置于胆管中以在愈合过程中充当桩,并在LT后4至6个月通过内窥镜取出。主要终点是LT后6个月内BC(瘘和狭窄)的发生率。次要标准是与IRS放置或拔除有关的并发症,包括内镜逆行胰胆管造影(ERCP)相关并发症。
未经批准:总共,235例患者被随机分配:IRS组117例,对照组118例。IRS组31例患者(26.5%)发生BC,与对照组24(20.3%)(p=0.27),包括16个(13.8%)和15个(12.8%)狭窄,分别。24例患者发生IRS迁移(20.5%),1例胆管炎(0.9%),急性胰腺炎2例(1.8%),19例(19.4%)在内镜下拔除困难。未鉴定出BC的预测因子。
UNASSIGNED:IRS不能预防LT后的BC,并且可能需要特定的内窥镜专业知识才能清除。
UNASSIGNED:NCT02356939(https://clinicaltrials.gov/ct2/show/NCT02356939?term=NCT02356939&draw=2&rank=1)。
未经证实:肝移植是许多终末期肝病患者的救命治疗。然而,它可能与涉及胆管重建的并发症有关。在这里,在接受肝移植的患者中,我们尝试放置一种称为导管内可移除支架的特殊支架,作为减少胆管并发症的一种方法.不幸的是,这无助于预防此类并发症。
UNASSIGNED: Biliary complications (BC) following liver transplantation (LT) are responsible for significant morbidity. No technical procedure during reconstruction has been associated with a risk reduction of BC. The placement of an intraductal removable stent (IRS) during reconstruction followed by its endoscopic removal showed feasibility and safety in a preliminary study. This multicentric randomised controlled trial aimed at evaluating the impact of an IRS on BC following LT.
UNASSIGNED: This multicentric randomised controlled trial was conducted in 7 centres from April 2015 to February 2019. Randomisation was done during LT when a duct-to-duct anastomosis was confirmed with at least 1 of the stump diameters ≤7 mm. In the IRS group, a custom-made segment of a T-tube was placed into the bile duct to act as a stake during healing and was removed endoscopically 4 to 6 months post LT. The primary endpoint was the incidence of BC (fistulae and strictures) within 6 months post LT. The secondary criteria were complications related to the IRS placement or extraction, including endoscopic retrograde cholangio-pancreatography (ERCP)-related complications.
UNASSIGNED: In total, 235 patients were randomised: 117 in the IRS group and 118 in the control group. BC occurred in 31 patients (26.5%) in the IRS group vs. 24 (20.3%) in the control group (p = 0.27), including 16 (13.8%) and 15 (12.8%) strictures, respectively. IRS migration occurred in 24 patients (20.5%), cholangitis in 1 (0.9%), acute pancreatitis in 2 (1.8%), and difficulty during endoscopic extraction in 19 (19.4%). No predictive factor for BC was identified.
UNASSIGNED: IRS does not prevent BC after LT and may require specific endoscopic expertise for removal.
UNASSIGNED: NCT02356939 (https://clinicaltrials.gov/ct2/show/NCT02356939?term=NCT02356939&draw=2&rank=1).
UNASSIGNED: Liver transplantation is a life-saving treatment for many patients with end-stage liver disease. However, it can be associated with complications involving the bile duct reconstruction. Herein, the placement of a specific stent called an intraductal removable stent was trialled as a way of reducing bile duct complications in patients undergoing liver transplantation. Unfortunately, it did not help preventing such complications.