Gallbladder Stones in Children and Correlation With Etiological Factors

NCT06660576 | Recruiting

• 1 other identifier: Soh-Med-15-10-7MS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallbladder Stone

Outcome Measures

Primary Outcomes (1)

• Early follow up to detect aetiology of gallbladder stones

  Aetiology of gallbladder stones

  One week after operation

Study Arms (1)

Gallbladder stones in children

OTHER

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

Procedure: Cholecystectomy and histochemical analysis of Gallbladder stones

Interventions

Cholecystectomy and histochemical analysis of Gallbladder stones PROCEDURE

Cholecystectomy and histochemical analysis of Gallbladder stones

Gallbladder stones in children

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• Age \>18 years. Asymptomatic patients who improved after follow up and medical treatment . Biliary anomaly as choledochal cyst , biliary stricture. Common bile duct stones .

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 17632509 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cholecystolithiasis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Haithem D Ahmed, Resident

CONTACT

01005036082; haithemdiaa@gmail.com

Nabil Y Abou Eldahab, Professor

CONTACT

+201122564413

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.Ch., Resident of Pediatric Surgery Sohag University Hospital

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: October 15, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

EG (1)