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随机临床试验:胆管结石所致疑似胆道梗阻患者行磁共振胰胆管造影术(MRCP)优先与逆行胰胆管造影术(ERCP)优先策略的比较。

Randomised clinical trial: MRCP-first vs. ERCP-first approach in patients with suspected biliary obstruction due to bile duct stones.

机构信息

Division of Gastroenterology, McGill University Health Center, McGill University, Montreal, Canada.

出版信息

Aliment Pharmacol Ther. 2013 Nov;38(9):1045-53. doi: 10.1111/apt.12481. Epub 2013 Sep 11.

DOI:10.1111/apt.12481
PMID:24024705
Abstract

BACKGROUND

The preferred initial investigation with either magnetic resonance (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) in patients with suspected biliary obstruction remains controversial in many clinical settings.

AIM

To assess the effectiveness of an initial MRCP vs. ERCP in the work-up of patients at moderate likelihood of a suspected biliary obstruction.

METHODS

Patients with an unconfirmed benign biliary obstruction, based on laboratory and ultrasound findings, were randomised to an ERCP-first or MRCP-first strategy, stratified by level of obstruction. The primary outcome was the occurrence of a disease or procedure-related bilio-pancreatic adverse events within the next 12 months. Secondary outcomes were the number of subsequent bilio-pancreatic procedures, duration of hospitalisation, days away from activities of daily living (ADL), quality of life (SF-36) and mortality.

RESULTS

We randomised 126 patients to ERCP-first and 131 to MRCP-first (age 54 ± 18 years, 62% female, 39% post-cholecystectomy). In follow-up, 18/126 (14.3%) ERCP-first and 25/131 (19.1%) MRCP-first patients experienced a procedure- or disease-related complication (P = 0.30) (disease-related in 13 and 18 patients, and procedure-related in 5 and 7 patients respectively). A cause of biliary obstruction was found in 39.7% vs. 49.6% of patients (P = 0.11). Sixty-six (50%) patients in the MRCP-first group ended up avoiding an ERCP in follow-up. ERCP-first and MRCP-first patients were away from usual activities for 3.4 ± 7.7 days and 2.0 ± 4.8 days respectively (P < 0.001).

CONCLUSION

A strategy of MRCP-first decreased the need for subsequent MRCPs, but not complications. Further study is required to define factors influencing the eventual use of MRCP vs. ERCP in appropriately selected patients (ClinicalTrial.gov: NCT01424657).

摘要

背景

在疑似胆道梗阻的许多临床情况下,首选磁共振胰胆管成像(MRCP)或内镜逆行胰胆管造影(ERCP)进行初始检查仍存在争议。

目的

评估初始 MRCP 与 ERCP 在疑似胆道梗阻中度可能性患者中的检查效果。

方法

根据实验室和超声检查结果,将未经证实的良性胆道梗阻患者随机分为 ERCP 优先组或 MRCP 优先组,按梗阻程度分层。主要结局是在接下来的 12 个月内发生与疾病或操作相关的胰胆管不良事件。次要结局是后续胰胆管操作的数量、住院时间、日常生活活动(ADL)丧失天数、生活质量(SF-36)和死亡率。

结果

我们将 126 例患者随机分为 ERCP 优先组,131 例患者分为 MRCP 优先组(年龄 54 ± 18 岁,62%为女性,39%为胆囊切除术后)。在随访中,18/126(14.3%)例 ERCP 优先组和 25/131(19.1%)例 MRCP 优先组患者经历了与操作或疾病相关的并发症(P = 0.30)(13 例和 18 例为疾病相关,5 例和 7 例为操作相关)。在 39.7%和 49.6%的患者中发现了胆道梗阻的原因(P = 0.11)。MRCP 优先组 66 例(50%)患者在随访中最终避免了 ERCP。MRCP 优先组和 ERCP 优先组患者分别有 3.4 ± 7.7 天和 2.0 ± 4.8 天不能从事日常活动(P < 0.001)。

结论

MRCP 优先策略减少了对后续 MRCP 的需求,但不能减少并发症。需要进一步研究来确定影响在适当选择的患者中最终使用 MRCP 与 ERCP 的因素(ClinicalTrials.gov:NCT01424657)。

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