Background

Indeterminate strictures pose a therapeutic dilemma. In recent years, cholangioscopy has evolved and the availability of cholangioscopy has increased. However, the position of cholangioscopy in the diagnostic algorithm to diagnose malignancy have not been well established. We aim to develop a consensus statement regarding the clinical role of cholangioscopy in the diagnosis of indeterminate biliary strictures.

Methods

The international experts reviewed the evidence and modified the statements using a three-step modified Delphi method. Each statement achieves consensus when it has at least 80% agreement.

Results

Nine final statements were formulated. An indeterminate biliary stricture is defined as that of uncertain etiology under imaging or tissue diagnosis. When available, cholangioscopic assessment and guided biopsy during the first round of ERCP may reduce the need to perform multiple procedures. Cholangioscopy are helpful in diagnosing malignant biliary strictures by both direct visualization and targeted biopsy. The absence of disease progression for at least 6 months is supportive of non-malignant etiology. Direct per-oral cholangioscopy provides the largest accessory channel, better image definition, with image enhancement but is technically demanding. Image enhancement during cholangioscopy may increase the diagnostic sensitivity of visual impression of malignant biliary strictures. Cholangioscopic imaging characteristics including tumor vessels, papillary projection, nodular or polypoid mass, and infiltrative lesions are highly suggestive for neoplastic/malignant biliary disease. The risk of cholangioscopy related cholangitis is higher than in standard ERCP, necessitating prophylactic antibiotics and ensuring adequate biliary drainage. Per-oral cholangioscopy may not be the modality of choice in the evaluation of distal biliary strictures due to inherent technical difficulties.

Conclusion

Evidence supports that cholangioscopy has an adjunct role to abdominal imaging and ERCP tissue acquisition in order to evaluate and diagnose indeterminate biliary strictures.

中文翻译：

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胆管镜诊断不确定性胆道狭窄作用的共识指南

背景

不确定的狭窄造成了治疗困境。近年来，胆管镜检查不断发展，胆管镜检查的可用性也有所增加。然而，胆管镜检查在诊断恶性肿瘤的诊断算法中的地位尚未明确。我们的目标是就胆管镜在诊断不确定性胆道狭窄中的临床作用达成共识。

方法

国际专家审查了证据并使用三步修正德尔菲法修改了陈述。当每项声明获得至少 80% 的同意时，即达成共识。

结果

制定了九项最终声明。不确定性胆道狭窄被定义为影像学或组织诊断下病因不确定的胆道狭窄。如果可行，第一轮 ERCP 期间的胆管镜评估和引导活检可能会减少执行多次手术的需要。胆管镜检查通过直接可视化和靶向活检有助于诊断恶性胆道狭窄。至少 6 个月没有疾病进展支持非恶性病因。直接经口胆管镜检查提供最大的辅助通道、更好的图像清晰度、图像增强功能，但技术要求较高。胆管镜检查过程中的图像增强可能会增加恶性胆管狭窄视觉印象的诊断敏感性。胆管镜成像特征包括肿瘤血管、乳头状投射、结节性或息肉样肿块以及浸润性病变，高度提示肿瘤/恶性胆道疾病。胆管镜检查相关胆管炎的风险高于标准 ERCP，因此需要预防性使用抗生素并确保充分的胆道引流。由于固有的技术困难，经口胆管镜检查可能不是评估远端胆道狭窄的首选方式。

结论

有证据表明，胆管镜检查可以辅助腹部成像和 ERCP 组织采集，以评估和诊断不确定的胆道狭窄。