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

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.

Study Overview

• Status: Completed
• Conditions: CBD Stone
• Intervention / Treatment: Device: Ambu aScope for visualization of biliary tree during exploration of CBD for stone

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Nepal
  • Province No-1
    • Dharān, Province No-1, Nepal, 56700
      • B. P. Koirala Institute of Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
use of Ambu aScope during open and laparoscopic CBD exploration	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of re-use of aScope during exploration of CBD for stone	Success 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)	intraoperative and early post operative upto 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic distribution of patients with CBD stone	Demographic distribution (in terms of mean age, gender, and stone characteristics) of patients who underwent CBD exploration using aScope as a choledochoscope	perioperative period upto 2weeks post-surgery

Collaborators and Investigators

• Sponsor: B.P. Koirala Institute of Health Sciences

Publications and helpful links

General Publications

• Chuang KT, Chuang SC, Kuo KK, Chang WT, Chuang SH, et al. (2024) Laparoscopic vs. Open Choledocholithiasis Interventions: Unraveling the Dominant Trends in Surgical Practice: A Single-Center, 6-Year, Retrospective Study. J Surg 9: 11089 https://doi.org/10.29011/2575-9760.
• Yi HJ, Hong G, Min SK, Lee HK. Long-term Outcome of Primary Closure After Laparoscopic Common Bile Duct Exploration Combined With Choledochoscopy. Surg Laparosc Endosc Percutan Tech. 2015 Jun;25(3):250-3. doi: 10.1097/SLE.0000000000000151.
• Daniel C, Pereira J, Prudente C, Constantino J, Sa M, Casimiro C. Laparoscopic choledochoscopy with Ambu(R) aScope 3 in the treatment of coledocholithiasis: a series of cases. J Surg Case Rep. 2018 Mar 29;2018(3):rjy046. doi: 10.1093/jscr/rjy046. eCollection 2018 Mar.
• Aawsaj YM, Ibrahim IK, Gilliam A. Novel method for laparoscopic common bile duct exploration performed using a disposable bronchoscope (Ambu® aScope TM). Kurdistan J Appl Res. 2017; 2: 49-51.
• Samir M, Selima M, Hefzy M. Choledochoscopy using disposable bronchoscope Ambu aScope 3: a single-institute experience. The Egyptian Journal of Surgery. 2022; 40(3). doi: 10.4103/ejs.ejs_166_21

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2025
• Primary Completion (Actual): September 10, 2025
• Study Completion (Actual): September 10, 2025

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopic; Open; Low-resource settings; Choledochoscope; Ambu aScope; CBD (Common Bile Duct) exploration
• Additional Relevant MeSH Terms: Cone Dystrophy; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Eye Diseases, Hereditary; Vision Disorders; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Color Vision Defects
• Other Study ID Numbers: IRC/2994/025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No