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内镜下逆行胰胆管造影术时对不确定性的胆道病变行常规和胆道镜引导下采样的诊断准确性:一项前瞻性长期随访

发布日期:2014-1-29 12:40:29 文章来源:GIE 作者次数:1260
    内镜下逆行胰胆管造影术时对不确定性的胆道病变行常规和胆道镜引导下采样的诊断准确性:一项前瞻性长期随访研究

    背景

    胆道镜引导下采样的诊断准确性还未经过严格的评估。

    前瞻性评估胆道镜引导下的微型医用镊子采样的准确性,并将这种方式与采用标准细胞刷活检钳诊断不确定性胆道病变组织等方式相比较。

    设计

    前瞻性,长期随访配对设计队列研究。

    环境

    三级中心。

    患者

    为评估不确定性胆道病变而接受胆道镜检查的患者。

    干预

    取样采用胆道镜引导的微型医用镊子,细胞刷和标准钳,每一例患者接受三次这样的取样。

    主要测量指标

    与患者的最终状态相比(有癌症与无癌症),每个采样方法的诊断准确率。

    结果

    本研究共26例患者参加,17例癌症表现为阳性,9例癌症表现为阴性。未患癌症患者的平均随访为21.78SD±6.78)个月。从技术上来说,这个手术对所有患者都是成功的。在采用细胞刷,标准活检钳和微型医用镊子取样的各26例患者中,分别有25例(96.2%),26100%),25例(96.2%)所取样本质量合适。采用标准细胞刷检所得出的灵敏度,准确率与阴性预测值分别为:5.9%,38.5%和36%;而采用标准镊子与微型医用镊子活检所得的这些参数值分别为:29.4%,53.8%,42.8%和76.5%,84.6%,69.2%。比较这三种取样方法,可得出,微型医用镊子活检灵敏度与整体准确率显著高于标准细胞刷检(P <0.0001)和标准镊子活检(p =0.0215)。

    局限性

    选择偏倚的可能性。

    结论

    对不确定性胆道病变行胆道镜引导的活检,这种活检准确率显著高于内镜下逆行胰胆管造影术引导的细胞刷检和标准镊子活检,但是采用微型医用镊子活检得出的阴性结果不能完全肯定地排除恶性肿瘤的可能。(临床试验注册号:NCT01227382

    缩写词:SD,标准偏差。

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    Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the time of ERCP: a prospective, long-term follow-up study

    Background

    The diagnostic accuracy of cholangioscopy-guided sampling has not been rigorously evaluated.

    Objective

    To prospectively evaluate the accuracy of cholangioscopy-guided mini-forceps sampling and compare it with standard cytology brushings and forceps biopsies for the tissue diagnosis of indeterminate biliary lesions.

    Design

    Prospective, long-term follow-up, paired design cohort study.

    Setting

    Tertiary center.

    Patients

    Patients undergoing cholangioscopy for the evaluation of indeterminate biliary lesions.

    Interventions

    Each patient underwent triple sampling with cholangioscopy-guided mini-forceps, cytology brushing, and standard forceps.

    Main Outcome Measurements

    Diagnostic accuracy of each sampling method compared with the patient final status (cancer vs no cancer).

    Results

    A total of 26 patients (17 cancer positive/9 cancer negative) were enrolled. The mean follow-up in the patients with no cancer was 21.78 (SD ±6.78) months. The procedure was technically successful in all cases (100%). Sample quality was adequate in 25 of 26 (96.2%) of the cytology brushings, in 26 of 26 (100%) of the standard forceps biopsies, and in 25 of 26 (96.2%) of the mini-forceps biopsies. The sensitivity, accuracy, and negative predictive values were 5.9%, 38.5%, and 36% for standard cytology brushings; 29.4%, 53.8%, and 42.8% for standard forceps biopsies; and 76.5%, 84.6%, and 69.2% for mini-forceps biopsies, respectively. When comparing the 3 methods of sampling, mini-forceps biopsy provided significantly better sensitivity and overall accuracy compared with standard cytology brushing (P < .0001) and standard forceps biopsy (P = .0215).

    Limitations

    Potential for selection bias.

    Conclusions

    Cholangioscopy-guided biopsies of indeterminate biliary lesions have significantly higher accuracy compared with ERCP-guided cytology brushings and standard forceps biopsies, but negative findings on mini-forceps biopsy cannot rule out malignancy with a high degree of certainty. (Clinical trial registration number: NCT01227382.)

    Abbreviation:  SD, standard deviation

     

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