Overview of Botriomycoma in Children with a Central Line: Epidemiology, Risk Factors, Treatments

Active, not recruiting

• Conditions: Home Parenteral Nutrition; Intestinal Failure; Central Line; Botriomycoma; Infection; Sepsis; Antibiotics

• Registration Number: NCT06708689
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Botriomycomas are frequent benign tumors in children. Their appearance on the central catheter orifice is a known event in clinical practice, but one that has been little studied. This lesion could lead to changes in pathways and an increase in the number of sepsis events, which would promote thrombosis and thus depletion of venous capital in patients who have been dependent on a central line for many years.

This study is a pilot study which will enable us to better identify the risk factors for the development of such a tumour, and to take stock of the different treatments used and their respective efficacy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2024-04-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Study Completion: 2025-03-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• home parenteral nutrition patients
• never diagnosed with an episode of botriomycoma on their central line
• 0 to 18 years of age at diagnosis

Exclusion Criteria

• Botriomycoma more than 10 years old at time of data collection (or lack of data)
• Patient over 18 years of age
• Not on home parenteral nutrition patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Appearance of Botryomycoma	From first diagnosis through a follow-up period of 2 years.	genetic characteristics (origin, phototype), local factors (mechanical, infectious), and general factors (history of sepsis).
Recurrence of Botryomycoma	From first diagnosis through a follow-up period of 2 years.	analyze risk factors for recurrence and evolution under different treatments.

Trial Locations

Locations (1)

Hôpital Mère-Enfant; 🇫🇷 Bron, France