NCT06974045

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

7.8 years

First QC Date

May 13, 2025

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Intraoperative measures

    Number of participants, size of choledochoscope used, rate of holmium laser lithotripsy use and stone clearance rates

    90 days

  • Postoperative complications

    Number of participants, number of complications (e.g. bile leak and pancreatitis), duration of hospital length of stay

    90 days

Study Arms (3)

Pre-pandemic

April 2016 to March 2020 (48 months)

Other: Single-stage LC + LCBDE

Intra-pandemic

March 2020 to December 2021 (22 months)

Other: Single-stage LC + LCBDE

Post-pandemic/recovery period

January 2022 to February 2024 (26 months)

Other: Single-stage LC + LCBDE

Interventions

Choledochotomy and transductal common bile duct exploration or transcystic choledochoscopy and common bile duct exploration

Intra-pandemicPost-pandemic/recovery periodPre-pandemic

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • Patients that underwent single-stage LC + LCBDE for the management of choledocholithiasis with concomitant gallstones.

You may not qualify if:

  • Patients that underwent LC only or LCBDE only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 15, 2025

Study Start

April 1, 2016

Primary Completion

February 1, 2024

Study Completion

May 1, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03