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

NCT07285447 | Completed DMC

• 1 other identifier: IRC/2994/025
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

CBD Stone

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Demographic distribution of patients with CBD stone

  perioperative period upto 2weeks post-surgery

Study Arms (1)

use of Ambu aScope during open and laparoscopic CBD exploration

Device: Ambu aScope for visualization of biliary tree during exploration of CBD for stone

Interventions

Ambu aScope for visualization of biliary tree during exploration of CBD for stone DEVICE

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

use of Ambu aScope during open and laparoscopic CBD exploration

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

B. P. Koirala Institute of Health Science

Dharān, Province No-1, 56700, Nepal

Location

Related Publications (5)

• 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.

  RESULT

• 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.

  PMID: 25856136 RESULT

• 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.

  PMID: 29977501 RESULT

• 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.

  RESULT

• 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

  RESULT

MeSH Terms

Conditions

Color Vision Defects

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 16, 2025
• Study Start: August 13, 2025
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)