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

November 26, 2024 updated by: Hospices Civils de Lyon

Retrospective Case-control Study of Central Line Botriomycoma in Children on Home Parenteral Nutrition: Epidemiology, Risk Factors, Treatments

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • Hôpital Mère-Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appearance of Botryomycoma
Time Frame: 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).
From first diagnosis through a follow-up period of 2 years.
Recurrence of Botryomycoma
Time Frame: From first diagnosis through a follow-up period of 2 years.
analyze risk factors for recurrence and evolution under different treatments.
From first diagnosis through a follow-up period of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

April 1, 2024

Study Completion (Estimated)

March 3, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_0638

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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