Gallbladder Stones in Children and Correlation With Etiological Factors

Not Applicable

Recruiting

• Conditions: Gallbladder Stone

• Registration Number: NCT06660576
• Lead Sponsor: Sohag University

Brief 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.

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 Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-15
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Early follow up to detect aetiology of gallbladder stones	One week after operation	Aetiology of gallbladder stones

Trial Locations

Locations (1)

Sohag university hospital; 🇪🇬 Sohag, Egypt