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

NCT06708689 | Active Not Recruiting

• 1 other identifier: 69HCL23_0638
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Appearance of Botryomycoma

  genetic characteristics (origin, phototype), local factors (mechanical, infectious), and general factors (history of sepsis).

  From first diagnosis through a follow-up period of 2 years.

• Recurrence of Botryomycoma

  analyze risk factors for recurrence and evolution under different treatments.

  From first diagnosis through a follow-up period of 2 years.

Study Arms (2)

Case / patients

Pediatric patients requiring a long-term central line for home parenteral nutrition: * home parenteral nutrition patients * diagnosed with at least on episode of botriomycoma on their central line * 0 to 18 years of age at diagnosis of botriomycoma

Control

Pediatric patients requiring a long-term central line for home parenteral nutrition: * home parenteral nutrition patients * never diagnosed with an episode of botriomycoma on their central line * 0 to 18 years of age at diagnosis

Eligibility Criteria

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

Study Population

Pediatric patients with intestinal failures requiring a long-term central line for home parenteral nutrition in France

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Mère-Enfant

Bron, France

Location

MeSH Terms

Conditions

Intestinal Failure; Infections; Sepsis

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 27, 2024
• Study Start: April 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: March 3, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

FR (1)