GallstoneNCT06974045
Impact of COVID-19 Pandemic on Single-stage Laparoscopic Cholecystectomy and Laparoscopic Common Bile Duct Exploration Service
An observational study of Gallstone, run by Imperial College London.
Trial summary
Choledocholithiasis is reported to be present in 15-20% of patients with symptomatic gallstones. The single-stage management consists of performing either laparoscopic common bile duct exploration (LCBDE) or intraoperative endoscopic retrograde cholangiopancreatography (ERCP) at the same time as laparoscopic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gallstone
- What is being tested?
- Single-stage LC + LCBDE
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 May 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients that underwent the single-stage approach of LC + LCBDE for the management of choledocholithiasis, between April 2016 and February 2024. All patients were assessed with preoperative liver function tests (LFTs) and abdominal imaging such as ultrasound, computed tomography (CT) and/ or magnetic resonance cholangiopancreatography (MRCP).
Who may be able to join
- Patients that underwent single-stage LC + LCBDE for the management of choledocholithiasis with concomitant gallstones.
Who cannot join
- Patients that underwent LC only or LCBDE only
About this study
Official title: Evaluation of a Single-stage Laparoscopic Cholecystectomy and Laparoscopic Common Bile Duct Exploration Service Pre-, Intra- and Post-COVID-19 Pandemic: a Retrospective Cohort Study
Choledocholithiasis is reported to be present in 15-20% of patients with symptomatic gallstones. The single-stage management consists of performing either laparoscopic common bile duct exploration (LCBDE) or intraoperative endoscopic retrograde cholangiopancreatography (ERCP) at the same time as laparoscopic cholecystectomy (LC).
Since the Coronavirus (COVID-19) pandemic, surgical practice has significantly been impacted. The pandemic has had ramifications on patient and staff safety, surgical techniques, minimally invasive procedures, theatre workflow, education and training.
The investigators analysed a series of LCBDE procedures in our institution pre-, intra- and post-COVID-19 pandemic to assess the feasibility, efficacy and safety of this single-stage treatment approach following the pandemic.
- Conditions
- Gallstone
- Being tested
- Single-stage LC + LCBDE
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-stage LC + LCBDEOther
Choledochotomy and transductal common bile duct exploration or transcystic choledochoscopy and common bile duct exploration
| Study group | Role | What they receive |
|---|---|---|
| Pre-pandemic | April 2016 to March 2020 (48 months) Receives: Other: Single-stage LC + LCBDE | |
| Intra-pandemic | March 2020 to December 2021 (22 months) Receives: Other: Single-stage LC + LCBDE | |
| Post-pandemic/recovery period | January 2022 to February 2024 (26 months) Receives: Other: Single-stage LC + LCBDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative measures
Number of participants, size of choledochoscope used, rate of holmium laser lithotripsy use and stone clearance rates
Measured: 90 days
Postoperative complications
Number of participants, number of complications (e.g. bile leak and pancreatitis), duration of hospital length of stay
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Apr 2016
- Primary completion1 Feb 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstoneStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974045
- Sponsor's protocol ID
- HH2025
- Status last verified
- Mar 2026
- First submitted
- 13 May 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Single-stage Laparoscopic Cholecystectomy and Laparoscopic Common Bile Duct Exploration Service Pre-, Intra- and Post-COVID-19 Pandemic: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06974045
- Acronym / sponsor ID
- HH2025
- Conditions
- Gallstone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 15 May 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.
Choledocholithiasis is reported to be present in 15-20% of patients with symptomatic gallstones. The single-stage management consists of performing either laparoscopic common bile duct exploration (LCBDE) or intraoperative endoscopic retrograde cholangiopancreatography (ERCP) at the same time as laparoscopic cholecystectomy (LC).
Since the Coronavirus (COVID-19) pandemic, surgical practice has significantly been impacted. The pandemic has had ramifications on patient and staff safety, surgical techniques, minimally invasive procedures, theatre workflow, education and training.
The investigators analysed a series of LCBDE procedures in our institution pre-, intra- and post-COVID-19 pandemic to assess the feasibility, efficacy and safety of this single-stage treatment approach following the pandemic.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-pandemic | – | Other: Single-stage LC + LCBDEApril 2016 to March 2020 (48 months) |
| Intra-pandemic | – | Other: Single-stage LC + LCBDEMarch 2020 to December 2021 (22 months) |
| Post-pandemic/recovery period | – | Other: Single-stage LC + LCBDEJanuary 2022 to February 2024 (26 months) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that underwent the single-stage approach of LC + LCBDE for the management of choledocholithiasis, between April 2016 and February 2024. All patients were assessed with preoperative liver function tests (LFTs) and abdominal imaging such as ultrasound, computed tomography (CT) and/ or magnetic resonance cholangiopancreatography (MRCP).
Key inclusion criteria (1 listed)
- Patients that underwent single-stage LC + LCBDE for the management of choledocholithiasis with concomitant gallstones.
Key exclusion criteria (1 listed)
- Patients that underwent LC only or LCBDE only
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 |
|---|---|---|
| Single-stage LC + LCBDECholedochotomy and transductal common bile duct exploration or transcystic choledochoscopy and common bile duct exploration | Other | Intra-pandemic, Post-pandemic/recovery period, Pre-pandemic |
Primary outcome
Intraoperative measures
Time frame: 90 days
Number of participants, size of choledochoscope used, rate of holmium laser lithotripsy use and stone clearance rates
Postoperative complications
Time frame: 90 days
Number of participants, number of complications (e.g. bile leak and pancreatitis), duration of hospital length of stay
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 27 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstone, run by Imperial College London.
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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Intraoperative measures (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.