Menu
Recruiting NCT06660576

Gallbladder Stones in Children and Correlation With Etiological Factors

No phase Interventional Gallbladder Stone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cholecystectomy and histochemical analysis of Gallbladder stones.
Who it may be relevant to
Registry conditions: Gallbladder Stone. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Histochemical Analysis of Gallbladder Stones in Children and Correlation With Etiological Factors

Overview

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 .

Interventions

  • Procedure Cholecystectomy and histochemical analysis of Gallbladder stones
    Cholecystectomy and histochemical analysis of Gallbladder stones

Primary outcome measures

  • Early follow up to detect aetiology of gallbladder stones [Time frame: One week after operation]

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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Egypt · 1 center
  • Sohag university hospital — Sohag

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 fac PMID 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. PMID 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. PMID 17197975

Identifiers

NCT: NCT06660576 · Soh-Med-15-10-7MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗