壶腹上方原发性经皮支架置入术与内镜引流术治疗不可切除性恶性肝门部胆管梗阻的比较（TESLA随机对照试验）：一项多中心随机对照试验的研究方案
Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial.
作者信息
Rousian M, van Verschuer V, Franssen S, Bijdevaate D, Bokkers R P H, Braat A E, de Bruijne J, Bruno M J, Burgmans M C, van Delden O M, Dewulf M, Erdmann J I, Hagendoorn J, van der Holt B, Hoogwater F J H, Inderson A, van der Leij C, Mohseny B, Poley J W, Smits M L J, van Vilsteren F G I, Voermans R P, Zijlstra I A J, van Driel L M J W, Koerkamp B Groot
机构信息
Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Department of Radiology, UMC Utrecht, University Medical Center, Utrecht, The Netherlands.
出版信息
BMC Cancer. 2025 May 9;25(1):849. doi: 10.1186/s12885-025-14158-0.
BACKGROUND
Patients with malignant hilar biliary obstruction typically present with painless jaundice. They commonly have perihilar cholangiocarcinoma (pCCA), but also intrahepatic cholangiocarcinoma, gallbladder cancer, and metastases to the liver hilum can present with hilar biliary obstruction. Endoscopic biliary drainage is the standard of care in most centers. Many patients develop drainage-related complications after endoscopic biliary drainage for malignant hilar biliary obstruction, in particular cholangitis, resulting in reinterventions, clinical deterioration and a high mortality rate. Primary percutaneous stenting (PPS) aims to avoid bacterial contamination and reduce drainage-related complications. The aim of this randomized controlled trial is to compare PPS with endoscopic biliary drainage in patients with unresectable malignant hilar biliary obstruction.
METHODS
This multicenter phase 3 randomized controlled trial (TESLA RCT) will recruit 148 patients with unresectable malignant hilar biliary obstruction in six Dutch tertiary academic referral centers. Diagnosis of malignant hilar biliary obstruction is pathologically confirmed or determined as very likely by the multidisciplinary team. In the intervention arm, patients undergo primary percutaneous stenting with uncovered self-expandable metal stents without crossing the ampulla and without leaving an external drain. In the control arm patients undergo endoscopic biliary drainage according to international guidelines. The primary endpoint is major complications within 90 days after randomization. Secondary outcomes include technical success, reintervention rates, decrease of bilirubin levels, eligibility for palliative systemic treatment, quality of life, and overall survival.
DISCUSSION
The multicenter TESLA RCT compares primary percutaneous stenting with endoscopic biliary drainage in patients with unresectable malignant hilar biliary obstruction. First patient was randomized on August 9, 2023.
TRIAL REGISTRATION
Netherlands Trial Register (NL-OMON53463), registered on May 12, 2023, and Clinicaltrials.gov (NCT06671418), registered on November 1, 2024.
背景
恶性肝门部胆管梗阻患者通常表现为无痛性黄疸。他们常见肝门周围胆管癌（pCCA），但肝内胆管癌、胆囊癌以及肝门转移瘤也可导致肝门部胆管梗阻。在大多数中心，内镜下胆管引流是标准治疗方法。许多患者在接受内镜下胆管引流治疗恶性肝门部胆管梗阻后会出现与引流相关的并发症，尤其是胆管炎，导致再次干预、临床病情恶化及高死亡率。原发性经皮支架置入术（PPS）旨在避免细菌污染并减少与引流相关的并发症。这项随机对照试验的目的是比较PPS与内镜下胆管引流术在不可切除的恶性肝门部胆管梗阻患者中的疗效。
方法
这项多中心3期随机对照试验（TESLA RCT）将在荷兰6家三级学术转诊中心招募148例不可切除的恶性肝门部胆管梗阻患者。恶性肝门部胆管梗阻的诊断需经病理证实或多学科团队判定极有可能。在干预组，患者接受原发性经皮支架置入术，使用未覆盖的自膨式金属支架，不穿过壶腹且不留置外部引流管。在对照组，患者根据国际指南接受内镜下胆管引流。主要终点是随机分组后90天内的主要并发症。次要结局包括技术成功率、再次干预率、胆红素水平下降情况、姑息性全身治疗的适用性、生活质量和总生存期。
讨论
多中心TESLA RCT比较了原发性经皮支架置入术与内镜下胆管引流术在不可切除的恶性肝门部胆管梗阻患者中的疗效。首例患者于2023年8月9日随机分组。
试验注册
荷兰试验注册库（NL-OMON53463），于2023年5月12日注册；Clinicaltrials.gov（NCT06671418），于2024年11月1日注册。
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