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Abstract：
Background and study aims Patients with primary sclerosing cholangitis (PSC) have a 9% to 20% lifetime incidence of cholangiocarcinoma (CCA). Per-oral cholangioscopy (POCS) added to endoscopic retrograde cholangiography (ERC) could potentially improve detection of CCA occurrence. We prospectively assessed POCS identification of 12-month CCA incidence in PSC patients undergoing ERC. Patients and methods Consecutive patients with PSC, an indication for ERC, and no prior liver transplantation were enrolled. During the index procedure, POCS preceded planned therapeutic maneuvers. The primary endpoint was ability for POCS visualization with POCS-guided biopsy to identify CCA during 12-month follow-up. Secondary endpoints included ability of ERC/cytology to identify CCA, repeat ERC, liver transplantation, and serious adverse events (SAEs). Results Of 42 patients enrolled, 36 with successful cholangioscope advancement were analyzed. Patients had a mean age 43.5±15.6 years and 61% were male. Three patients diagnosed with CCA had POCS visualization impressions of benign/suspicious/suspicious, and respective POCS-guided biopsy findings of suspicious/positive/suspicious for malignancy at the index procedure. The three CCA cases had ERC visualization impressions of benign/benign/suspicious, and respective cytology findings of atypical/atypical/suspicious for malignancy. No additional patients were diagnosed with CCA during median 11.5-month follow-up. Twenty-three repeat ERCs (5 including POCS) were performed in 14 patients. Five patients had liver transplantation, one after CCA diagnosis and four after benign cytology at the index procedure. Three patients (7.1%) had post-ERC pancreatitis. No SAEs were POCS-related. Conclusions In PSC patients, POCS visualization/biopsy and ERC/cytology each identified three cases of CCA. Some patients had a repeat procedure and none experienced POCS-related SAEs.
摘要：
背景和研究目的原发性硬化性胆管炎（PSC）患者的胆管癌（CCA）终生发病率为9％至20％。将经口胆道镜检查（POCS）添加到内窥镜逆行胆道造影（ERC）可以潜在地改善CCA发生的检测。我们前瞻性评估了接受ERC的PSC患者12个月CCA发生率的POCS鉴定。患者和方法连续PSC患者，ERC的指示，并且没有纳入先前的肝移植。在索引过程中，POCS先于计划的治疗措施。主要终点是在12个月随访期间通过POCS引导活检进行POCS可视化以识别CCA的能力。次要终点包括ERC/细胞学鉴定CCA的能力，重复ERC,肝移植,和严重不良事件（SAE）。结果在42例患者中，分析了36例成功的胆道镜进展。患者平均年龄43.5±15.6岁，61%为男性。3例诊断为CCA的患者POCS可视化印象为良性/可疑/可疑，以及在索引程序中可疑/阳性/可疑恶性肿瘤的相应POCS引导活检结果。3例CCA患者ERC可视化印象为良性/良性/可疑，以及非典型/非典型/可疑恶性肿瘤的细胞学检查结果。在中位11.5个月的随访期间，没有其他患者被诊断为CCA。14例患者进行了23例重复ERC（5例，包括POCS）。5例患者进行了肝移植,CCA诊断后1例，在索引程序中进行良性细胞学检查后4例。3例患者（7.1％）患有ERC后胰腺炎。没有SAE与POCS相关。结论在PSC患者中,POCS可视化/活检和ERC/细胞学检查均确定了3例CCA。一些患者重复手术，没有出现POCS相关的SAE。
