Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID06660576

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

Led by Sohag University · Updated on 2024-10-28

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study the relationship between causes of pediatric gallbladder stones and their analysis after surgery. It focuses on children under 18 years old who have symptomatic or certain asymptomatic gallbladder stones, including those with congenital hemolytic anemia or specific imaging findings. The study is prospective and will take place from October 2024 to August 2025 at Sohag University Hospital's Department of Pediatric Surgery. Children in this study will undergo cholecystectomy, which is the surgical removal of the gallbladder, followed by histochemical analysis of their gallbladder stones. The study will investigate how different causes relate to the stone composition after this surgical procedure. There are no comparison groups or placebo treatments, and the study involves only this intervention. Participants will be followed up early, about one week after the operation, to detect the cause of their gallbladder stones. The study involves monitoring symptoms such as biliary colic, fever, vomiting, and imaging measurements like gallbladder thickness. Data collected will help understand the etiology of stones in children. The total study duration spans approximately 10 months, with ongoing evaluations and no mention of long-term follow-up beyond the initial postoperative period.

CONDITIONS

Brief Title

Gallbladder Stones in Children and Correlation With Etiological Factors

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age under 18 years
  • Symptomatic gallbladder stones with symptoms such as biliary colic, fever, vomiting, or positive Murphy sign
  • Diagnosis of congenital hemolytic anemia with gallbladder stones
  • Asymptomatic gallbladder stones smaller than 5mm after one year of Ursodeoxycholic acid treatment
  • Imaging showing large gallbladder stone less than 1cm in diameter or gallbladder thickness greater than 3mm, whether symptomatic or asymptomatic
Not Eligible

You will not qualify if you...

  • Age over 18 years
  • Asymptomatic patients who improved after follow-up and medical treatment
  • Presence of biliary anomalies such as choledochal cyst or biliary stricture
  • Presence of stones in the common bile duct

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of surgery

Participants undergo cholecystectomy and histochemical analysis of gallbladder stones.

1 visit (in-person)

Early Follow-up

Duration - 1 week after operation

Participants are followed up to detect the aetiology of gallbladder stones.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Sohag university hospital

Sohag, Egypt

Actively Recruiting

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Research Team

H

Haithem D Ahmed, Resident

N

Nabil Y Abou Eldahab, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

A genome-wide association scan identifies the hepatic cholesterol transporter ABCG8 as a susceptibility factor for human gallstone disease.

Stephan Buch, Clemens Schafmayer, Henry Völzke...

https://pubmed.ncbi.nlm.nih.gov/17632509