国产一次性电子胰胆管内窥镜在胆管疾病中的初步应用(含视频)

Clinical application of disposable cholangiopancreatoscope to bile duct diseases(with video)

目的初步评价一次性电子胰胆管内窥镜在胆管疾病诊治中的安全性、有效性以及性能指标分析。方法2021年7—8月浙江大学医学院附属杭州市第一人民医院消化内镜中心共筛选20例受试者,实际入组16例受试者进行前瞻性、探索性临床研究。使用国产一次性电子胰胆管内窥镜在常规经内镜逆行胰胆管造影术中对受试者进行胆管疾病诊断,对考虑恶性肿瘤者予以活检,并对器械使用相关指标和性能指标进行分析。结果入组的16例患者术前诊断胆管占位6例,胆管结石6例,胆管良性狭窄4例。一次性胰胆管镜插镜成功率100.00%(16/16),观察成功率100.00%(16/16)。3例胆管占位患者镜下诊断为恶性肿瘤,术后得到病理证实;其余患者一次性胰胆管镜诊断考虑与术前诊断一致,未予以活检。操作者方向调控性评价好评率81.25%(13/16),图像故障率18.75%(3/16),图像清晰评价好评率93.75%(15/16)。临床性能指标评价中,成像质量优占93.75%(15/16),弯角性能优占81.25%(13/16),其余指标均为100.00%优。操作期间均未发生器械缺陷和胰腺炎、穿孔、出血等与器械有关的不良事件。结论本研究所使用的国产一次性电子胰胆管内窥镜在有效性、安全性、性能指标方面均达到了临床可用的标准,同时还具备了高像素和高度集成化便携性的特性,有临床推广使用的价值。

Objective To evaluate the safety,efficacy and performance of disposable cholangiopancreatoscope in the diagnosis and treatment of bile duct diseases.Methods A total of 20 subjects were selected and 16 subjects were enrolled in the prospective and exploratory clinical study which were performed in the Digestive Endoscope Center of Hangzhou First People's Hospital Affiliated to Zhejiang University School of Medicine from July 2021 to August 2021.The disposable cholangiopancreatoscope was used to diagnose bile duct diseases in routine endoscopic retrograde cholangiopancreatography.Biopsies were performed in cases where malignancy was considered.The use related indexes and performance indexes of the instruments were analyzed.Results Among the 16 patients,there were 6 cases of biliary space-occupying lesions,6 cases of biliary calculi,and 4 cases of benign biliary stricture before operation.The success rate of the disposable insertion was 100.00%(16/16),and the success rate of observation was 100.00%(16/16).Three biliary space-occupying lesions diagnosed as malignant tumor under cholangiopancreatoscope were confirmed by pathology after operation.Diagnosis of other patients was consistent with preoperative diagnose,so no biopsy was conducted.The rate of positive feedback from operators in directional control was 81.25%(13/16),the image failure rate was 18.75%(3/16),and the rate of positive feedback for image clarity was 93.75%(15/16).In terms of clinical performance,the imaging quality of excellence was 93.75%(15/16),the flexible degree of excellence was 81.25%(13/16),and other indexes were all 100.00%excellence.During the period,there were no instrument defects,pancreatitis,perforation,bleeding or other instrument-related adverse events.Conclusion The effectiveness,safety and performance indexes of domestic disposable cholangiopancreatoscope have reached the standards of clinical application with high pixel,integration,and portability.It's worthy of clinical recommendation.