Clinical application of disposable cholangiopancreatoscope to bile duct diseases (with video)
10.3760/cma.j.cn321463-20211227-00772
- VernacularTitle: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）
- Author:
Hongzhang SHEN
1
;
Jianfeng YANG
;
Hangbin JIN
;
Jixian WAN
;
Haitao HUANG
;
Qifeng LOU
;
Jian ZHANG
;
Xiaofeng ZHANG
Author Information
1. 浙江大学医学院附属杭州市第一人民医院消化内科 杭州市消化疾病研究所 浙江省中西医结合胆胰疾病重点实验室，杭州 310006
- Keywords:
Cholangiopancreatography, endoscopic retrograde;
Cholangiopancreatoscope;
Domestic;
Safety;
Efficiency;
Performance
- From:
Chinese Journal of Digestive Endoscopy
2022;39(9):719-724
- CountryChina
- Language:Chinese
-
Abstract:
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.
