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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07285447
Enrollment
75
Registered
2025-12-16
Start date
2025-08-13
Completion date
2025-09-10
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CBD Stone

Keywords

Ambu aScope, Choledochoscope, CBD (Common Bile Duct) exploration, Laparoscopic, Open, Low-resource settings

Brief 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.

Interventions

DEVICEAmbu 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

Sponsors

B.P. Koirala Institute of Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* all patients with CBD stones who underwent CBD exploration for stone using the Ambu aScope in Department of Surgery of BPKIHS, Dharan between January 2022 and December 2024

Exclusion criteria

* Single stone of \<1cm, Patient not fit for general anesthesia, Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of re-use of aScope during exploration of CBD for stoneintraoperative and early post operative upto 2 weeksSuccess rate (in percentage) of achieving acceptable view of extrahepatic biliary tree form the 2nd generation biliary radicles proximally to the ampulla of Vater distally with Ambu aScope. Stone clearance rate (in percentage) with the use of ambu aScope Occurrence (in terms of percentage) of complications (such as Injury to biliary tree, Cholangitis related with reuse of the aScope)

Secondary

MeasureTime frameDescription
Demographic distribution of patients with CBD stoneperioperative period upto 2weeks post-surgeryDemographic distribution (in terms of mean age, gender, and stone characteristics) of patients who underwent CBD exploration using aScope as a choledochoscope

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 23, 2026