Performing Cholecystectomy in Patients With Chronic Calcular CholeycystitsNCT06349876
Cholecystectomy in Patients With Silent Common Bile Duct Stones
An observational study of Performing Cholecystectomy in Patients With Chronic Calcular Choleycystits, run by Suez University at 3 sites in Egypt.
Trial summary
Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Performing Cholecystectomy in Patients With Chronic Calcular Choleycystits
- What is being tested?
- laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 3 sitesEgypt
- Study dates
- 15 Feb 2023to 15 Jan 2024
- 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 25 to 60 years
- All sexes
- Adult
Study population: patients presented by chronic calcular cholecystitis and during investigation they discovers that they have silent common bile duct stones
Who may be able to join
- Patients with asymptomatic common bile duct stones.
- Patients with normal bilirubin levels.
- Patients with normal alkaline phosphates level.
Who cannot join
- Patients with history of jaundice.
- Patients with abnormal liver functions.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Qeft Teatching Hospital
Qina
Qena Faculty of Medicine
Qina
Suez Faculty of Medicine
Suez, 43221
About this study
Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones
- Being tested
- laparoscopic cholecystectomy
- Keywords
- CBD stones ,, cholecystectomy, silent stones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cholecystectomyProcedure or surgery
slandered laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| lap chole | patients presented by cholecystitis with silent CBD stones Receives: Procedure: laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients developed jaundice post cholecystectomy
patients presented by symptomatic gall bladder stones and during investigation discovered that they have silent common bile duct stone so we assess the safety of performing cholecystectomy without developing jaundice
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start15 Feb 2023
- Primary completion15 Jul 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Performing Cholecystectomy in Patients With Chronic Calcular CholeycystitsStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Ali Maklad, Suez University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349876
- Sponsor's protocol ID
- SUEZ MED - IRB Approval NO: 6
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maklad AA, Eltantawy M, Siam M, Abdelshafy M. Feasibility of cholecystectomy in patients with silent common bile duct stones cohort prospective single arm multicentre study. BMC Gastroenterol. 2025 Mar 11;25(1):158. doi: 10.1186/s12876-024-03459-6.
PubMed 40069599
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholecystectomy in Patients With Silent Common Bile Duct Stones
- ClinicalTrials.gov ID
- NCT06349876
- Acronym / sponsor ID
- SUEZ MED - IRB Approval NO: 6
- Keywords
- CBD stones ,, cholecystectomy, silent stones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suez UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 5 Apr 2024 (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.
Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lap chole | – | Procedure: laparoscopic cholecystectomypatients presented by cholecystitis with silent CBD stones |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- patients presented by chronic calcular cholecystitis and during investigation they discovers that they have silent common bile duct stones
Key inclusion criteria (3 listed)
- Patients with asymptomatic common bile duct stones.
- Patients with normal bilirubin levels.
- Patients with normal alkaline phosphates level.
Key exclusion criteria (2 listed)
- Patients with history of jaundice.
- Patients with abnormal liver functions.
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 |
|---|---|---|
| laparoscopic cholecystectomyslandered laparoscopic cholecystectomy | Procedure or surgery | lap chole |
Primary outcome
number of patients developed jaundice post cholecystectomy
Time frame: 6 months
patients presented by symptomatic gall bladder stones and during investigation discovered that they have silent common bile duct stone so we assess the safety of performing cholecystectomy without developing jaundice
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 23 Apr 2024.
- Derived from this study: PubMed 40069599Maklad AA, Eltantawy M, Siam M, Abdelshafy M. Feasibility of cholecystectomy in patients with silent common bile duct stones cohort prospective single arm multicentre study. BMC Gastroenterol. 2025 Mar 11;25(1):158. doi: 10.1186/s12876-024-03459-6.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Performing Cholecystectomy in Patients With Chronic Calcular Choleycystits, run by Suez University at 3 sites 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 3 inclusion and 2 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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
number of patients developed jaundice post cholecystectomy (time frame: 6 months). 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 NCT06349876, which also lists 1 linked publication.
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 23 Apr 2024.