Calcular Obstructive JaundiceNCT05979233
One Session Vs Staged Management of Calcular Obstructive Jaundice
A study testing staged managment, one session ERCP then LC and one session LC then ERCP in people with Calcular Obstructive Jaundice and Gall Bladder Disease, run by Minia University at 1 site in Egypt.
Trial summary
to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Calcular Obstructive Jaundice, Gall Bladder Disease
- What is being tested?
- staged managment, one session ERCP then LC and one session LC then ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2023to 20 Feb 2025
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18-70 year
- combined CBD and gall stone
- stone less than 1.5 cm
- fit for surgery
- no upper abdominal surgery
Who cannot join
- age <18 and >70
- unfit for surgery
- stone more than 1.5 cm
- upper abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Session Vs Staged Laropendoscopic Management of Calcular Obstructive Jaundice
to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management
Read the detailed description
to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy then ERCP in the same session in group 3 we will do staged management
- Being tested
- staged managment, one session ERCP then LC, one session LC then ERCP
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
staged managmentProcedure or surgery
staged management
one session ERCP then LCProcedure or surgery
one session ERCP then LC
one session LC then ERCPProcedure or surgery
one session LC then ERCP
| Study group | Role | What they receive |
|---|---|---|
| staged managment | Active comparator | ERCP then interval laparoscopic cholecystectomy Receives: Procedure: staged managment |
| one session ERCP then LC | Experimental | one session ERCP then LC Receives: Procedure: one session ERCP then LC |
| one session LC then ERCP | Experimental | one session LC then ERCP Receives: Procedure: one session LC then ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
total cost
total cost in Egyptian pound
Measured: 6 months
hospital stay
total hospital stay in days
Measured: 6 months
Secondary outcomes (1)
complications
early postoperative complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start5 Aug 2023
- Primary completion21 Apr 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcular Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Minia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mstafa Hassan Sewefy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979233
- Sponsor's protocol ID
- fac.med.23.42
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2023
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Session Vs Staged Laropendoscopic Management of Calcular Obstructive Jaundice
- ClinicalTrials.gov ID
- NCT05979233
- Acronym / sponsor ID
- fac.med.23.42
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 21 Apr 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 7 Aug 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.
to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management
Detailed description
to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy then ERCP in the same session in group 3 we will do staged management
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| staged managment | Active comparator | Procedure: staged managmentERCP then interval laparoscopic cholecystectomy |
| one session ERCP then LC | Experimental | Procedure: one session ERCP then LCone session ERCP then LC |
| one session LC then ERCP | Experimental | Procedure: one session LC then ERCPone session LC then ERCP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age from 18-70 year
- combined CBD and gall stone
- stone less than 1.5 cm
- fit for surgery
- no upper abdominal surgery
Key exclusion criteria (4 listed)
- age <18 and >70
- unfit for surgery
- stone more than 1.5 cm
- 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 |
|---|---|---|
| staged managmentstaged management | Procedure or surgery | staged managment |
| one session ERCP then LCone session ERCP then LC | Procedure or surgery | one session ERCP then LC |
| one session LC then ERCPone session LC then ERCP | Procedure or surgery | one session LC then ERCP |
Primary outcome
total cost
Time frame: 6 months
total cost in Egyptian pound
hospital stay
Time frame: 6 months
total hospital stay in days
1 secondary outcome
complications
Time frame: 30 days
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 15 Oct 2026.
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*Effect of Prophylactic CBD Stenting Versus Non Stenting on Recurrence of CBD Stones in Patients Awaiting Cholecystectomy*
Calcular Obstructive Jaundice
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?
A study testing staged managment, one session ERCP then LC and one session LC then ERCP in people with Calcular Obstructive Jaundice and Gall Bladder Disease, run by Minia University at 1 site in Egypt.
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 5 inclusion and 4 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 15 Oct 2026. 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 Egypt. 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?
total cost (time frame: 6 months). 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 15 Oct 2026.