Gallbladder StoneNCT06660576
Gallbladder Stones in Children and Correlation With Etiological Factors
A study testing Cholecystectomy and histochemical analysis of Gallbladder stones in people with Gallbladder Stone, run by Sohag University at 1 site in Egypt.
Trial summary
Aims of the Study: The objective of this study is to estimate the correlation between etiological factors and postoperative histochemical analysis of pediatric gallbladder stones. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Gallbladder Stone
- What is being tested?
- Cholecystectomy and histochemical analysis of Gallbladder stones
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2024to 1 Aug 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age <18 years . Symptomatic gallbladder stones (biliary colic, fever, vomiting, positive Murphy sign ) .
- Congenital hemolytic anemia with gallbladder stones. Asymptomatic patient with gallbladder stones <5mm after medical treatment (Ursodeoxycholic acid ) for 1year .
- Imaging criteria ( large gallbladder stone < 1cm diameter , gallbladder thickness >3mm ) either symptomatic or asymptomatic .
Who cannot join
- Age >18 years. Asymptomatic patients who improved after follow up and medical treatment . Biliary anomaly as choledochal cyst , biliary stricture. Common bile duct stones .
Trial locations and contacts
1 site in 1 country.
Nabil Y Abou Eldahab, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, Professor
About this study
Official title: Histochemical Analysis of Gallbladder Stones in Children and Correlation With Etiological Factors
Aims of the Study:
The objective of this study is to estimate the correlation between etiological factors and postoperative histochemical analysis of pediatric gallbladder stones.
Read the detailed description
Study design:
A prospective, cohort study. Duration of the study: The study starts from October 2024 to August 2025.
Place of the study:
The study will be held in Department of Pediatric surgery in Sohag University Hospital.
Inclusion and exclusion criteria:
Inclusion criteria:
Age <18 years . Symptomatic gallbladder stones (biliary colic, fever, vomiting, positive Murphy sign ) .
Congenital hemolytic anemia with gallbladder stones. Asymptomatic patient with gallbladder stones <5mm after medical treatment (Ursodeoxycholic acid ) for 1year .
Imaging criteria ( large gallbladder stone < 1cm diameter , gallbladder thickness >3mm ) either symptomatic or asymptomatic .
Exclusion criteria:
Age >18 years. Asymptomatic patients who improved after follow up and medical treatment . Biliary anomaly as choledochal cyst , biliary stricture. Common bile duct stones .
- Conditions
- Gallbladder Stone
- Being tested
- Cholecystectomy and histochemical analysis of Gallbladder stones
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecystectomy and histochemical analysis of Gallbladder stonesProcedure or surgery
Cholecystectomy and histochemical analysis of Gallbladder stones
| Study group | Role | What they receive |
|---|---|---|
| Gallbladder stones in children | Other | Histochemical analysis of Gallbladder stones in children and correction with aetiological factors Receives: Procedure: Cholecystectomy and histochemical analysis of Gallbladder stones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early follow up to detect aetiology of gallbladder stones
Aetiology of gallbladder stones
Measured: One week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start15 Oct 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gallbladder StoneStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hitham Diaaeldin Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660576
- Sponsor's protocol ID
- Soh-Med-15-10-7MS
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buch S, Schafmayer C, Volzke H, Becker C, Franke A, von Eller-Eberstein H, Kluck C, Bassmann I, Brosch M, Lammert F, Miquel JF, Nervi F, Wittig M, Rosskopf D, Timm B, Holl C, Seeger M, ElSharawy A, Lu T, Egberts J, Fandrich F, Folsch UR, Krawczak M, Schreiber S, Nurnberg P, Tepel J, Hampe J. A genome-wide association scan identifies the hepatic cholesterol transporter ABCG8 as a susceptibility factor for human gallstone disease. Nat Genet. 2007 Aug;39(8):995-9. doi: 10.1038/ng2101. Epub 2007 Jul 15.
PubMed 17632509Wesdorp I, Bosman D, de Graaff A, Aronson D, van der Blij F, Taminiau J. Clinical presentations and predisposing factors of cholelithiasis and sludge in children. J Pediatr Gastroenterol Nutr. 2000 Oct;31(4):411-7. doi: 10.1097/00005176-200010000-00015.
PubMed 11045839Curro G, Meo A, Ippolito D, Pusiol A, Cucinotta E. Asymptomatic cholelithiasis in children with sickle cell disease: early or delayed cholecystectomy? Ann Surg. 2007 Jan;245(1):126-9. doi: 10.1097/01.sla.0000242716.66878.23.
PubMed 17197975
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histochemical Analysis of Gallbladder Stones in Children and Correlation With Etiological Factors
- ClinicalTrials.gov ID
- NCT06660576
- Acronym / sponsor ID
- Soh-Med-15-10-7MS
- Conditions
- Gallbladder Stone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 28 Oct 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.
Aims of the Study:
The objective of this study is to estimate the correlation between etiological factors and postoperative histochemical analysis of pediatric gallbladder stones.
Detailed description
Study design:
A prospective, cohort study. Duration of the study: The study starts from October 2024 to August 2025.
Place of the study:
The study will be held in Department of Pediatric surgery in Sohag University Hospital.
Inclusion and exclusion criteria:
Inclusion criteria:
Age <18 years . Symptomatic gallbladder stones (biliary colic, fever, vomiting, positive Murphy sign ) .
Congenital hemolytic anemia with gallbladder stones. Asymptomatic patient with gallbladder stones <5mm after medical treatment (Ursodeoxycholic acid ) for 1year .
Imaging criteria ( large gallbladder stone < 1cm diameter , gallbladder thickness >3mm ) either symptomatic or asymptomatic .
Exclusion criteria:
Age >18 years. Asymptomatic patients who improved after follow up and medical treatment . Biliary anomaly as choledochal cyst , biliary stricture. Common bile duct stones .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gallbladder stones in children | Other | Procedure: Cholecystectomy and histochemical analysis of Gallbladder stonesHistochemical analysis of Gallbladder stones in children and correction with aetiological factors |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age <18 years . Symptomatic gallbladder stones (biliary colic, fever, vomiting, positive Murphy sign ) .
- Congenital hemolytic anemia with gallbladder stones. Asymptomatic patient with gallbladder stones <5mm after medical treatment (Ursodeoxycholic acid ) for 1year .
- Imaging criteria ( large gallbladder stone < 1cm diameter , gallbladder thickness >3mm ) either symptomatic or asymptomatic .
Key exclusion criteria (1 listed)
- Age >18 years. Asymptomatic patients who improved after follow up and medical treatment . Biliary anomaly as choledochal cyst , biliary stricture. Common bile duct stones .
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 |
|---|---|---|
| Cholecystectomy and histochemical analysis of Gallbladder stonesCholecystectomy and histochemical analysis of Gallbladder stones | Procedure or surgery | Gallbladder stones in children |
Primary outcome
Early follow up to detect aetiology of gallbladder stones
Time frame: One week after operation
Aetiology of gallbladder stones
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Background: PubMed 17632509Buch S, Schafmayer C, Volzke H, Becker C, Franke A, von Eller-Eberstein H, Kluck C, Bassmann I, Brosch M, Lammert F, Miquel JF, Nervi F, Wittig M, Rosskopf D, Timm B, Holl C, Seeger M, ElSharawy A, Lu T, Egberts J, Fandrich F, Folsch UR, Krawczak M, Schreiber S, Nurnberg P, Tepel J, Hampe J. A genome-wide association scan identifies the hepatic cholesterol transporter ABCG8 as a susceptibility factor for human gallstone disease. Nat Genet. 2007 Aug;39(8):995-9. doi: 10.1038/ng2101. Epub 2007 Jul 15.
- Background: PubMed 11045839Wesdorp I, Bosman D, de Graaff A, Aronson D, van der Blij F, Taminiau J. Clinical presentations and predisposing factors of cholelithiasis and sludge in children. J Pediatr Gastroenterol Nutr. 2000 Oct;31(4):411-7. doi: 10.1097/00005176-200010000-00015.
- Background: PubMed 17197975Curro G, Meo A, Ippolito D, Pusiol A, Cucinotta E. Asymptomatic cholelithiasis in children with sickle cell disease: early or delayed cholecystectomy? Ann Surg. 2007 Jan;245(1):126-9. doi: 10.1097/01.sla.0000242716.66878.23.
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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.
Nabil Y Abou Eldahab, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecystectomy and histochemical analysis of Gallbladder stones in people with Gallbladder Stone, run by Sohag 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 3 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: status not confirmed, as of the sponsor's last update on 28 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haithem D Ahmed, Resident (01005036082, haithemdiaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early follow up to detect aetiology of gallbladder stones (time frame: One week after operation). 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 NCT06660576, which also lists 3 linked publications.
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 28 Oct 2024.