Kongkam Pradermchai, Pittayanon Rapat, Sampatanukul Pichet, Angsuwatcharakon Phonthep, Aniwan Satimai, Prueksapanich Piyapan, Sriuranpong Virote, Navicharern Patpong, Treeprasertsuk Sombat, Kullavanijaya Pinit, Rerknimitr Rungsun
Gastrointestinal Endoscopy Excellent Center, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Department of Pathology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Endosc Int Open. 2016 Jan;4(1):E17-23. doi: 10.1055/s-0034-1393183. Epub 2015 Nov 5.
Endoscopic ultrasound-guided needle-based confocal laser endomicroscopy (EUS-nCLE) has been shown to aid in the diagnosis of cystic pancreatic lesions. This is a pilot project to study its findings in patients with solid pancreatic lesions (SPLs) with a prospective single-blinded study design.
Patients with SPLs undergoing trans-gastric EUS fine needle aspiration (EUS-FNA) from July 2013 to March 2014 were prospectively enrolled. The nCLE diagnoses were compared with the final diagnoses. Researchers learned about the EUS-nCLE findings from previously published studies and applied it to diagnose SPLs. In the meantime, the findings were recorded.
In total, 22 patients were recruited (mean age 62.7 years, SD 13.8 years; 14 men and eight women). The mean maximal tumor diameter was 36.0 mm (SD 10.9 mm). EUS-nCLE yielded satisfactory images in all patients during the first EUS procedure and diagnosed benign and malignant SPLs in 3 and 19 patients, respectively. Final diagnoses of malignant SPLs were made in 19 patients. Benign SPLs were eventually diagnosed in three patients, with confirmed the cytology and disease stability during the 12-month follow-up period. At the end of the project, based on the results of this current study, EUS-nCLE findings for malignant SPLs were dark clumping with or without dilated vessels (> 40 μm). There were two criteria for diagnosing benign lesions which were white fibrous bands and normal acini cells. The accuracy rate of EUS-nCLE was 90.9 % (20/22). One falsely diagnosed malignant SPL was an inflammatory mass from a recent acute pancreatitis. Another one with a pancreatic neuroendocrine tumor presenting with a symptomatic pseudocyst was incorrectly diagnosed as an inflammatory mass. This was likely from sampling error of the EUS-nCLE probe in an inflammatory area. Only one patient had post EUS-FNA bleeding but did not require a blood transfusion. The inter-observer agreement among three blinded endoscopists was almost perfect (Kappa 0.82).
EUS-nCLE is a promising technique for the diagnosis of SPLs with good inter-observer agreement. Study registration: TCTR20140402001.
内镜超声引导下基于针的共聚焦激光内镜检查（EUS-nCLE）已被证明有助于诊断胰腺囊性病变。这是一项采用前瞻性单盲研究设计，研究其在实性胰腺病变（SPL）患者中的表现的试点项目。
前瞻性纳入2013年7月至2014年3月期间接受经胃EUS细针穿刺抽吸（EUS-FNA）的SPL患者。将nCLE诊断结果与最终诊断结果进行比较。研究人员了解先前发表的研究中的EUS-nCLE结果，并将其应用于诊断SPL。同时，记录结果。
共招募了22例患者（平均年龄62.7岁，标准差13.8岁；男性14例，女性8例）。肿瘤最大直径平均为36.0mm（标准差10.9mm）。在首次EUS检查过程中，EUS-nCLE在所有患者中均获得了满意的图像，分别诊断出3例良性和19例恶性SPL。最终诊断为19例恶性SPL。最终诊断出3例良性SPL，在12个月的随访期内细胞学检查得到证实且病情稳定。在项目结束时，根据本研究结果，恶性SPL的EUS-nCLE表现为有或无扩张血管（>40μm）的暗团块。诊断良性病变有两个标准，即白色纤维带和正常腺泡细胞。EUS-nCLE的准确率为90.9%（20/22）。1例假诊断为恶性的SPL是近期急性胰腺炎引起的炎性肿块。另一例胰腺神经内分泌肿瘤伴症状性假性囊肿被错误诊断为炎性肿块。这可能是由于EUS-nCLE探头在炎症区域的采样误差所致。仅1例患者在EUS-FNA后出现出血，但无需输血。三位盲法内镜医师之间的观察者间一致性几乎完美（Kappa值为0.82）。
EUS-nCLE是一种有前景的诊断SPL的技术，观察者间一致性良好。研究注册号：TCTR20140402001。
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