Reuterwall Marcus, Lubbe Jeanne, Enochsson Lars, Lundell Lars, Konradsson Magnus, Swahn Frederik, Del Chiaro Marco, Löhr Matthias, Arnelo Urban
Division of Surgery, CLINTEC, Karolinska Institutet, Center for Digestive Diseases, Karolinska University Hospital, Huddinge, 114 86, Stockholm, Sweden.
Division of Surgery, University of Stellenbosch, Tygerberg Hospital, Cape Town, South Africa.
BMC Gastroenterol. 2019 Feb 26;19(1):35. doi: 10.1186/s12876-019-0953-9.
Single-operator, per-oral cholangiopancreatoscopy (SOPCP) enables direct biliopancreatic ductal visualization, targeted tissue sampling, and therapeutic intervention. At Karolinska University Hospital, SOPCP was introduced early and has since been extensively utilized according to a standardized protocol. We analysed the clinical value of SOPCP in the diagnosis and treatment of biliopancreatic diseases in a single high volume center.
All SOPCP procedures performed between March 2007 and December 2014 were retrospectively reviewed. Each procedure's diagnostic yield and therapeutic value was evaluated using a predefined 4 grade scale; 1 - no diagnostic or therapeutic value, 2 - information gained did not impact clinical decision-making and in case of a therapeutic intervention, did not alter the clinical course of the patient, 3 - information gained had an impact on clinical decision-making and in the case of a therapeutic intervention, assisted subsequent disease management, and finally, 4 - information gained was essential and critical for clinical decision-making and in case of a therapeutic intervention, solved the clinical problem requiring no further therapeutic actions. Descriptive statistics were used to analyse results, with uni- and multivariate analyses completed to assess risk of adverse events.
During the study period, 365 SOPCP procedures were performed. We found SOPCP of pivotal importance (grade 4) in 19% of cases, and of great clinical significance (grade 3) in 44% of cases. SOPCP did not affect clinical decision-making or alter clinical course (grade 1 and 2) in 37% of cases.
SOPCP offers direct access to the biliopancreatic ducts for both diagnostic and therapeutic purposes, adding significant clinical value in 64% of cases.
As this is a purely observational and retrospectively registered study in which the assignment of the medical intervention was not at the discretion of the investigator, it has not been registered in a registry.
单操作者经口胆管胰管镜检查（SOPCP）可实现对胆管和胰管的直接可视化、靶向组织采样及治疗干预。在卡罗林斯卡大学医院，SOPCP较早引入，此后一直按照标准化方案广泛应用。我们在一个高病例量的单一中心分析了SOPCP在胆胰疾病诊断和治疗中的临床价值。
回顾性分析2007年3月至2014年12月期间进行的所有SOPCP操作。使用预先定义的4级量表评估每个操作的诊断率和治疗价值；1级 - 无诊断或治疗价值，2级 - 获得的信息未影响临床决策，且在进行治疗干预时未改变患者的临床病程，3级 - 获得的信息影响了临床决策，且在进行治疗干预时有助于后续疾病管理，最后，4级 - 获得的信息对临床决策至关重要且在进行治疗干预时解决了临床问题，无需进一步治疗措施。采用描述性统计分析结果，并进行单因素和多因素分析以评估不良事件风险。
在研究期间，共进行了365例SOPCP操作。我们发现19%的病例中SOPCP至关重要（4级），44%的病例中具有重大临床意义（3级）。37%的病例中SOPCP未影响临床决策或改变临床病程（1级和2级）。
SOPCP可直接进入胆管和胰管用于诊断和治疗目的，在64%的病例中增加了显著的临床价值。
由于这是一项纯观察性的回顾性注册研究，其中医疗干预的分配不由研究者决定，因此未在任何注册机构注册。
