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RecruitingNCT06660576Updated Oct 28, 2024

Gallbladder Stones in Children and Correlation With Etiological Factors

An interventional study of Cholecystectomy and histochemical analysis of Gallbladder stones in Gallbladder Stone, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Sohag University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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 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 .

02

Conditions studied

  • Gallbladder Stone

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03

In context

Cholecystolithiasis

88 studies on the registry are indexed under Cholecystolithiasis; 17 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 59 interventional studies indexed under Cholecystolithiasis.

Browse Cholecystolithiasis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion 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 .
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Gallbladder stones in children

    Histochemical analysis of Gallbladder stones in children and correction with aetiological factors

    Procedure: Cholecystectomy and histochemical analysis of Gallbladder stones

Interventions

  • ProcedureCholecystectomy and histochemical analysis of Gallbladder stones

    Cholecystectomy and histochemical analysis of Gallbladder stones

06

What researchers measure

Primary outcomes

  1. Early follow up to detect aetiology of gallbladder stones

    Aetiology of gallbladder stones

    Time frame: One week after operation

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 17632509 ↗
  • Wesdorp 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 11045839 ↗
  • Curro 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Aug 2025, 9 months after the start.

Of 27 interventional studies with no phase under Cholecystolithiasis, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's planned 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2024
First posted
Oct 28, 2024
StartActual
Oct 15, 2024
Primary completionEst.
Aug 1, 2025
CompletionEst.
Aug 1, 2025
Last update
Oct 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06660576
Lead sponsor
Sohag University
Responsible party
Hitham Diaaeldin Ahmed (M.B.B.Ch., Resident of Pediatric Surgery Sohag University Hospital, Sohag University) — Principal investigator
First posted
Oct 28, 2024
Start date
Oct 15, 2024
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Oct 28, 2024

Study contacts

Haithem D Ahmed, Resident
Contact
haithemdiaa@gmail.com
01005036082
Nabil Y Abou Eldahab, Professor
Contact
+201122564413

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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