CBD StoneNCT07285447
Re-use of Ambu aScope During Exploration of the Common Bile Duct for Stones in Low-Resource Settings- a Retrospective Study
An observational study of CBD Stone, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- CBD Stone
- What is being tested?
- Ambu aScope for visualization of biliary tree during exploration of CBD for stone
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteNepal
- Study dates
- 13 Aug 2025to 10 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Single stone of <1cm, Patient not fit for general anesthesia, Pregnancy
Trial locations and contacts
1 site in 1 country.
Nepal1 site
B. P. Koirala Institute of Health Science
Dharān, Province No-1, 56700
About this 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.
- Conditions
- CBD Stone
- Being tested
- Ambu aScope for visualization of biliary tree during exploration of CBD for stone
- Keywords
- Ambu aScope, Choledochoscope, CBD (Common Bile Duct) exploration, Laparoscopic, Open, Low-resource settings
- Medical subject headings
- Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu aScope for visualization of biliary tree during exploration of CBD for stoneDevice
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
| Study group | Role | What they receive |
|---|---|---|
| use of Ambu aScope during open and laparoscopic CBD exploration | Not described Receives: Device: Ambu aScope for visualization of biliary tree during exploration of CBD for stone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: intraoperative and early post operative upto 2 weeks
Secondary outcomes (1)
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
Measured: perioperative period upto 2weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start13 Aug 2025
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CBD StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhijeet Kumar, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285447
- Sponsor's protocol ID
- IRC/2994/025
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25856136Daniel 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.
PubMed 29977501Aawsaj 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 at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-use of Ambu aScope During Exploration of the Common Bile Duct for Stones in Low-Resource Settings- a Retrospective Study
- ClinicalTrials.gov ID
- NCT07285447
- Acronym / sponsor ID
- IRC/2994/025
- Conditions
- CBD Stone
- Keywords
- Ambu aScope, Choledochoscope, CBD (Common Bile Duct) exploration, Laparoscopic, Open, Low-resource settings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| use of Ambu aScope during open and laparoscopic CBD exploration | – | Device: Ambu aScope for visualization of biliary tree during exploration of CBD for stone |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Single stone of <1cm, Patient not fit for general anesthesia, Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambu aScope for visualization of biliary tree during exploration of CBD for stoneAmbu 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 | Device | use of Ambu aScope during open and laparoscopic CBD exploration |
Primary outcome
Feasibility of re-use of aScope during exploration of CBD for stone
Time frame: intraoperative and early post operative upto 2 weeks
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)
1 secondary outcome
Demographic distribution of patients with CBD stone
Time frame: perioperative period upto 2weeks post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Results publicationChuang 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.
- Results publication: PubMed 25856136Yi 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.
- Results publication: PubMed 29977501Daniel 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.
- Results publicationAawsaj 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.
- Results publicationSamir 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CBD Stone, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of re-use of aScope during exploration of CBD for stone (time frame: intraoperative and early post operative upto 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07285447, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.