Common Bile Duct CalculiNCT05823181
Early Versus Late Laparoscopic Exploration of Common Bile Duct After Failure of Extraction of Common Bile Duct Stones by ERCP
An observational study of Common Bile Duct Calculi, run by Assiut University.
Trial summary
The goal of this work is to assess the best time to perform LC combined with LCBD exploration and the feasibility and safety of such procedure in patients with combined GBS and CBDS after failure of ERCP extraction of CBD stones . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Common Bile Duct Calculi
- What is being tested?
- laparoscopy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to Nov 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that presented with calcular obstructive jaundice 2ry to CBD stones and failed of extraction of common bile duct stone by ERCP.
Who may be able to join
- All patients that presented with calcular obstructive jaundice 2ry to CBD stones.
- Failed of extraction of common bile duct stone by ERCP.
Who cannot join
- patients presented by cholangitis.
- patients presented by acute pancreatitis.
- Patients that developed post ERCP pancreatitis ,bleeding , perforation.
- history of previous biliary surgery rather than cholecystectomy.
- history of major upper abdominal surgery.
- pregnant females.
- patients with liverchirosis, abdominal malignancy , and those unfit for surgery.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this work is to assess the best time to perform LC combined with LCBD exploration and the feasibility and safety of such procedure in patients with combined GBS and CBDS after failure of ERCP extraction of CBD stones .
- Conditions
- Common Bile Duct Calculi
- Being tested
- laparoscopy
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopyDevice
laparoscopic exploration of common bile duct
| Study group | Role | What they receive |
|---|---|---|
| Early laparoscopic exploration of common bile duct | Early laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP Receives: Device: laparoscopy | |
| Late laparoscopic exploration of common bile duct | late laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP Receives: Device: laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative complications
- Assess the operative time in hours
- intraoperative blood loss in millilitres
- intraoperative organ injury (yes or no)
- conversion to open surgery (yes or no)
Measured: Baseline
Secondary outcomes (1)
postoperative complications
- Postoperative bleeding in millilitres
- biliary leakage in millilitres
- missed stone (yes or no)
- recumbency complications which are monitored for 30 days postoperatively. 5.Overall length of hospital stay and if Intensive Care Unit (ICU) stay needed will also be recorded in days.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Sep 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct CalculiStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebram Abdelmalak Abd, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823181
- Sponsor's protocol ID
- CBD stone
- Status last verified
- Apr 2023
- First submitted
- 25 Feb 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Laparoscopic Exploration of Common Bile Duct After Failure of Extraction of Common Bile Duct Stones by ERCP
- ClinicalTrials.gov ID
- NCT05823181
- Acronym / sponsor ID
- CBD stone
- Conditions
- Common Bile Duct Calculi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 21 Apr 2023 (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.
The goal of this work is to assess the best time to perform LC combined with LCBD exploration and the feasibility and safety of such procedure in patients with combined GBS and CBDS after failure of ERCP extraction of CBD stones .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early laparoscopic exploration of common bile duct | – | Device: laparoscopyEarly laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP |
| Late laparoscopic exploration of common bile duct | – | Device: laparoscopylate laparoscopic exploration of common bile duct after failure of extraction of common bile duct stones by ERCP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that presented with calcular obstructive jaundice 2ry to CBD stones and failed of extraction of common bile duct stone by ERCP.
Key inclusion criteria (2 listed)
- All patients that presented with calcular obstructive jaundice 2ry to CBD stones.
- Failed of extraction of common bile duct stone by ERCP.
Key exclusion criteria (7 listed)
- patients presented by cholangitis.
- patients presented by acute pancreatitis.
- Patients that developed post ERCP pancreatitis ,bleeding , perforation.
- history of previous biliary surgery rather than cholecystectomy.
- history of major upper abdominal surgery.
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 |
|---|---|---|
| laparoscopylaparoscopic exploration of common bile duct | Device | Early laparoscopic exploration of common bile duct, Late laparoscopic exploration of common bile duct |
Primary outcome
intraoperative complications
Time frame: Baseline
1. Assess the operative time in hours 2. intraoperative blood loss in millilitres 3. intraoperative organ injury (yes or no) 4. conversion to open surgery (yes or no)
1 secondary outcome
postoperative complications
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Bile Duct Calculi, run by Assiut University.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebram Abdelmalak Abd Awad, Resident dr (01208032279, ebrammalak195@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative complications (time frame: Baseline). 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 21 Apr 2023.