NCT07285447

Re-use of Ambu aScope During Exploration of the Common Bile Duct for Stones in Low-Resource Settings- a Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: B.P. Koirala Institute of Health Sciences · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Various methods confirm stone clearance during surgical exploration of bile duct, but choledochoscopy is considered the most effective. However, choledochoscopes are expensive and often unavailable in low-resource settings. The Ambu aScope, a disposable flexible video-bronchoscope used in anesthesia, has been successfully tried as a cheaper alternative for CBD (Common Bile Duct) exploration in other countries. In Nepal, where affordability is a concern, reuse of properly disinfected Ambu aScopes may be justifiable if proven safe. Existing studies are limited and small in scale; this study is the first from Nepal to evaluate the reuse of Ambu aScope for choledochoscopy. This retrospective observational study will include all patients with CBD stones who underwent CBD exploration for stone using Ambu aScope in Department of Surgery of BPKIHS, Dharan between January 2022 and December 2024. Case record files of all patients who underwent CBD exploration using aScope as a Choledochoscope over last 3 years period will be obtained from medical record section and computer database of our department. All relevant information including patient demographics, indication for a CBD exploration, operative approach and procedure performed, intraoperative achievement of acceptable view of extrahepatic biliary tree using an aScope, intraoperative stone clearance on direct visualization of biliary tree and confirmation on postoperative T-tube cholangiogram or imaging on 10-14th postoperative day and intra/post-operative complications associated with the use of the aScope will be entered in a preformed proforma. In case of some missing information in medical case report sheet or computer database of our department, patient will be called directly on the contact number provided in admission sheet and through the telephonic conversation, the concerned queries will be cleared. Data will be entered in Microsoft Excel and analyzed by SPSS version 29.0.1.0. Qualitative data were described using numbers and percentages. Quantitative data will be described using range (minimum and maximum), mean, standard deviation, and median.

Conditions

• CBD Stone

Interventions

Type	Name	Description
DEVICE	Ambu aScope for visualization of biliary tree during exploration of CBD for stone	Ambu aScope, in stead of choledochoscope in low-reource settings, can be used for visualization of biliary tree and retrieval of stone during surgical open or laparoscopic exploration of CBD

Timeline

• Start date: 2025-08-13
• Primary completion: 2025-09-10
• Completion: 2025-09-10
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: Nepal